This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection (NCT05476250), a na na study. The primary outcome is Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05476250 |
| Phase | NA |
| Condition | Healthy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 120 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Masimo Corporation |
| Results posted | Yes |
2. Clinical Question
The clinical question concerns whether the noninvasive Masimo INVSENSOR00057 can correctly identify people who do not have atrial fibrillation. The registry names specificity as the primary endpoint and describes the intended validation as a comparison of noninvasive ECG measurements with results from an FDA-cleared ECG monitor. The record does not report the observed specificity or an analysis comparing device measurements with monitor results.
Population
The listed condition is Healthy. Enrollment is 120. The primary endpoint description notes that 1 subject was not analyzed because of an EDC error. Further details about the people enrolled and the endpoint analysis population are not reported in the registry record.
Intervention
Participants in the test group who enrolled and participated in data collection received the noninvasive INVSENSOR00057 device.
Comparator
The study summary says the device’s noninvasive ECG measurements were to be compared with results from an FDA-cleared ECG monitor. The registry does not list a separate control arm; the study model is single group.
Primary question
How well does INVSENSOR00057 identify individuals without atrial fibrillation, as assessed by specificity? The registry gives a timeframe of 1-5 hours but reports no numerical result, confidence interval, or analysis.
This is a device-performance question, not a randomized treatment comparison. The record does not establish how the comparison was carried out, what reference interpretation was used, or how discordant readings were handled. Those details are not reported in the registry record. Without the endpoint estimate and its uncertainty, the clinical question is stated but cannot be answered from the posted results.
3. Trial Design
The registry describes a single-group study of Masimo INVSENSOR00057, a noninvasive device intended for atrial fibrillation detection. Its brief summary says the device’s ECG measurements would be compared with results from an FDA-cleared ECG monitor. The registry lists enrollment as 120 and the condition as Healthy. It does not describe a parallel control group or a randomized allocation. Allocation is recorded as NA, and masking is listed as NONE.
The intervention description says all subjects enrolled into the test group and participating in data collection receive INVSENSOR00057. That arrangement is consistent with evaluating a device in a test group, rather than comparing treatment assignments. The monitor is mentioned as a measurement comparator in the study summary, not as a separately assigned arm. Details of the monitor, measurement sequence, and procedures for pairing or adjudicating readings are not reported in the registry record.
The recorded study start is 2022-08-01, and primary completion is recorded as 2022-08-10. The current status is TERMINATED. The reason for termination and any consequences for data collection are not reported in the registry record. The listed primary endpoint timeframe is 1-5 hours; the record does not explain the timing of individual measurements within that interval.
The registry lists one primary outcome measure and no analyses. The endpoint description notes that 1 subject was not analyzed due to an EDC error, but it does not give a result or explain the analysis population further. The protocol, sample-size justification, stopping rules, and details of the statistical analysis plan are not reported in the registry record. Therefore, the design can be described as a single-group device evaluation with a planned monitor comparison, but important operational and analytical details remain unavailable.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Masimo INVSENSOR00057 |
|---|---|
| STARTED | 120 |
| COMPLETED | 99 |
| NOT COMPLETED | 21 |
Analysis population for the primary outcome, as defined in the registry: 1 subject not analyzed due to EDC error.
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Masimo INVSENSOR00057 |
|---|---|---|
| Participants analysed | 99 | |
| Age, Categorical: <=18 years | Participants | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 98 |
| Age, Categorical: >=65 years | Participants | 1 |
| Sex: Female, Male: Female | Participants | 35 |
| Sex: Female, Male: Male | Participants | 64 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 1 |
| Race (NIH/OMB): Asian | Participants | 27 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 11 |
| Race (NIH/OMB): White | Participants | 34 |
| Race (NIH/OMB): More than one race | Participants | 7 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 19 |
| Region of Enrollment: United States | participants | 99 |
6. Primary Endpoint
The registry lists the primary outcome as Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function, measured over 1-5 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | % of true negatives |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled Specificity of Masimo INVSENSOR00057 Atrial Fibrillation Detection Function. Specificity describes how often a test correctly classifies people who do not have the condition being assessed. In this study’s description, the relevant classification is identifying individuals who do not have atrial fibrillation. The registry expresses the unit as % of true negatives and says that high specificity is important for minimizing false positives.
In general, specificity is used to characterize the false-positive side of a diagnostic test’s performance. A false positive occurs when a person without the condition is classified as having it. Specificity is distinct from sensitivity, which concerns identification of people who do have the condition. A single metric does not describe every aspect of diagnostic performance, so interpretation typically depends on the clinical question and the quality of the reference classification.
The endpoint timeframe is 1-5 hours. The primary endpoint description also states that 1 subject was not analyzed due to an EDC error. No numerical specificity estimate, denominator, confidence interval, or endpoint analysis is reported in the registry record. The registry summary mentions comparison with an FDA-cleared ECG monitor, but does not report the specific reference procedure or how disagreements were resolved. Consequently, the endpoint’s purpose is clear, while its observed performance and precision cannot be assessed from the posted results.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies specificity as the primary outcome, but no endpoint value is reported. There is therefore no posted estimate to interpret, and no basis in the registry record for concluding how often INVSENSOR00057 correctly identified people without atrial fibrillation. The endpoint description explains the intended meaning of specificity and its relevance to false positives; it does not supply observed performance.
The record lists one outcome measure and no analyses. It does not provide a confidence interval, p-value, comparison estimate, or other measure of uncertainty. Without an estimate and its uncertainty, precision cannot be judged. A confidence interval, in general, indicates a range of values compatible with the data under the analysis assumptions; it is not a substitute for a clearly described endpoint definition and analysis population. No such interval is reported for this endpoint.
The study summary describes a comparison between the device’s noninvasive ECG measurements and results from an FDA-cleared ECG monitor. That description establishes the intended comparator role but does not show how the measurements agreed, whether the classification rules matched, or what reference standard was used. The record lists no separate control arm and identifies the model as single group. It should therefore not be read as a randomized comparison between device and control groups.
The primary endpoint description notes that 1 subject was not analyzed because of an EDC error. That is a specific explanation for exclusion of that subject from the endpoint analysis, but the registry does not describe other missing or unusable data, the total endpoint denominator, or any sensitivity analysis. It is not possible to infer an analyzed sample size from the enrollment listing and this note; the necessary participant flow and outcome details are not reported in the registry record.
The status is TERMINATED. The reason for termination, whether all planned measurements were collected, and whether termination affected the available endpoint data are not reported in the registry record. The status alone does not establish why the study ended or what the data would have shown under a different course of conduct.
Safety entries list 0 serious adverse events and 0 other adverse events in the device group, with 120 at risk in each category. These are registry-recorded counts for the reported group. They do not fill the gap in the primary performance result and should not be interpreted as proof that no adverse events could occur. The duration and completeness of safety observation are not reported in the registry record.
Overall, the posted information establishes the intended diagnostic-performance question and some design features, but it does not provide the evidence needed to quantify performance. No conclusion about the device’s accuracy, reproducibility, or clinical usefulness follows from an endpoint title or a study purpose statement alone.
9. Statistical Methods Explained
The statistical methods that can be described from the registry are limited. It identifies a single-group device study, names specificity as the primary endpoint, and lists no analyses. A detailed statistical analysis plan is not reported in the registry record. The distinctions below explain the concepts relevant to the endpoint without assuming that any particular procedure was used.
What does specificity measure?
In general, specificity is the proportion of people who do not have a condition and are correctly classified as not having it by a test. Its complement is the false-positive rate: the share of people without the condition who are classified as positive. Specificity therefore addresses one particular form of diagnostic error. It does not by itself describe how well the device detects people who do have atrial fibrillation; that is a separate question usually addressed by sensitivity.
To estimate specificity, an analysis needs a defined set of observations classified as not having the condition by a reference method, along with the device classifications for those observations. The registry’s outcome description says specificity concerns correctly identifying individuals who do not have atrial fibrillation, and the study summary mentions comparison with an FDA-cleared ECG monitor. The exact reference classification rules, observation unit, handling of repeat measurements, and calculation method are not reported in the registry record. Without those definitions, the endpoint’s general meaning is available, but its exact operational implementation cannot be assessed.
Why does the reference method matter?
Diagnostic performance is measured relative to a reference classification. If the reference method or its interpretation is uncertain, the estimated performance describes agreement with that reference rather than an independent, error-free truth. In general, a prespecified reference procedure and consistent interpretation help make diagnostic estimates easier to interpret. The record does not identify the monitor model, the person or process interpreting its readings, or whether readings were reviewed without knowledge of the device result. Those details are not reported in the registry record.
Agreement and specificity are also not interchangeable. A device could agree with a comparator in some respects while still making false-positive classifications among people without the condition. The intended specificity endpoint focuses on one part of the classification task. Since no observed classifications or endpoint estimate are posted, neither the level of agreement nor the frequency of false positives can be quantified.
What does uncertainty add?
A point estimate, if reported, would describe the observed performance in the analyzed data. A confidence interval would add information about statistical uncertainty under the assumptions of the analysis. In general, uncertainty depends on the number and distribution of relevant observations and on the analysis structure. Repeated readings from the same person, for example, may not behave like independent observations. Methods that ignore dependence can make uncertainty appear smaller than it is. The registry does not report whether observations were repeated, how such observations were handled, or an interval estimate.
No p-value or hypothesis test is listed. A p-value, in general, measures how surprising data would be under a specified statistical model and null hypothesis; it does not state the probability that a device performs well, nor does it measure clinical importance. Because no test or analysis is reported, there is no inferential result to interpret. The registry also does not state a target threshold for acceptable specificity, so the record does not support a threshold-based assessment.
What can a planning illustration establish?
Planning calculations are not trial outcomes. The registry’s planning assumptions describe an illustration using a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. They are explicitly not the trial’s own design assumptions. The trial itself is listed as single group, so an equal-allocation, two-arm illustration should not be confused with the design that was registered.
The illustration is not observed power. In general, power is a design quantity calculated under assumed effects and variability; after a study, observed power does not replace an estimate and its confidence interval. Because the registry does not report an observed endpoint estimate or an analysis, the stated assumptions cannot establish what performance was observed or how precise it was. The protocol’s sample-size justification and any original design calculations are not reported in the registry record.
What does the analysis record leave unresolved?
The registry lists no analyses, which means it does not supply a reported statistical analysis to evaluate. It is not possible to determine whether the endpoint was calculated as planned, whether any alternative analysis was conducted, or whether a decision rule was applied. The record also does not report treatment of missing readings, exclusions beyond the stated EDC-error case, adjustments for repeated observations, or subgroup analyses. These are not assumed to have occurred; their status is not reported in the registry record.
For a diagnostic study, clear reporting would ordinarily connect the endpoint definition to the reference classification, analysis population, numerator and denominator, estimate, and uncertainty. Those elements allow readers to distinguish the test’s observed classification performance from the assumptions used in its analysis. Here, the registry states the endpoint’s intended meaning and notes one subject not analyzed, but offers no numerical performance result or statistical analysis. Interpretation must therefore stop at the stated study objective and design description.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one primary outcome measure and no analyses. It does not report a multiplicity adjustment, a hierarchy of hypotheses, or a plan for handling multiple statistical tests. With no analysis results listed, there is no reported collection of inferential tests from which to assess multiplicity. Whether the protocol anticipated additional outcomes or exploratory analyses is not reported in the registry record.
Missing-data information is limited. The primary endpoint description states that 1 subject was not analyzed due to an EDC error. The record does not describe the nature of the error, whether the device measurement or comparator result was affected, or whether any replacement, imputation, or sensitivity analysis was used. It also does not give an endpoint denominator or describe missing readings for other participants. The enrollment figure cannot be treated as the endpoint analysis population.
The analysis population is not defined beyond the note about the subject not analyzed. The registry does not state whether all enrolled participants, only those with paired device and comparator readings, or another group was intended for the primary analysis. A participant-flow account and the handling of invalid or incomplete measurements are not reported in the registry record. These omissions limit assessment of selection effects and the relationship between the enrolled group and the data used for the endpoint.
In general, multiplicity and missingness matter because they can affect both the chance of a false-positive finding and the representativeness of an estimate. That general concern does not establish that either problem occurred in this study. The posted information is insufficient to evaluate those possibilities or to determine whether prespecified procedures were followed.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Masimo INVSENSOR00057 | 0 | 120 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Masimo INVSENSOR00057 | 0 of 120 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Masimo INVSENSOR00057 | 0 of 120 |
The safety record lists the Masimo INVSENSOR00057 group with 120 at risk for serious adverse events and 0 affected. It also lists 120 at risk for other adverse events and 0 affected. The deaths count is 0, and no serious adverse-event terms are listed. These are the counts recorded for the listed group, not findings about diagnostic performance.
Zero recorded events means that the registry reports no events in those categories for the group. It does not show that the device carries no risk, nor does it rule out events that were not captured, reported, or observed during the study. The record does not describe the duration or completeness of safety follow-up, how events were collected, or the criteria used to classify events. Those details are not reported in the registry record.
The at-risk figures should be read as the registry’s group-level safety denominators. They do not resolve the separate endpoint note that 1 subject was not analyzed due to an EDC error, because the record does not say that the safety and primary-endpoint analysis populations were identical. The safety counts should not be converted into a broader conclusion about safety beyond the categories and group reported.
12. What the Result Does, and Does Not, Mean
The record establishes that Masimo INVSENSOR00057 was studied for atrial fibrillation detection in a single-group device study and that specificity was named as the primary endpoint. The study summary describes comparison of noninvasive ECG measurements with an FDA-cleared ECG monitor. These registry entries define the intended evaluation, but they do not provide its outcome.
The record does not report the specificity estimate, its denominator, a confidence interval, or any statistical analysis. It therefore does not show how often the device correctly classified people without atrial fibrillation, how uncertain such an estimate would be, or how its performance compared with a prespecified target. No claim that the device performs well or poorly can be drawn from the endpoint title alone.
The single-group design and absence of a listed randomized control arm also matter. This is not a randomized comparison of assigned groups. The monitor is described as a comparator for ECG measurements, but the detailed reference procedure and comparison results are not reported. Consequently, the record does not support a quantified statement about agreement or diagnostic accuracy.
The registry identifies one subject not analyzed due to an EDC error but does not provide a full analysis population or participant flow. It lists the study status as TERMINATED without reporting the reason. Neither the status nor the exclusion note establishes the direction or magnitude of any effect on the missing endpoint result.
The safety entries report no serious or other adverse events in the listed group, and no deaths. These counts describe the safety information recorded; they do not establish absence of risk beyond the observation and reporting described in the registry. Overall, the record communicates the study’s purpose and selected design details, while leaving the central performance result and key analytical context unavailable.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between a diagnostic question and a treatment-comparison question. A device intended to classify ECG readings is evaluated by how its classifications relate to a reference method. Specificity focuses on false-positive classifications among people without the condition. That is different from comparing outcomes between randomized treatment groups, and the registry identifies this study as single group rather than a randomized comparison.
The endpoint also illustrates why a stated outcome is not the same as a reported result. Naming specificity and explaining its relevance to false positives describes what the study sought to assess. To evaluate the performance claim statistically, readers also need the observed estimate, the relevant analysis population, and an indication of precision. None is reported in the registry record. Without those elements, the study objective cannot be translated into a quantitative conclusion.
Reference methods are central to diagnostic evaluations. A comparison with an FDA-cleared ECG monitor is part of the study summary, but the record does not explain the reference interpretation or how paired measurements were analyzed. In general, those details help readers understand what the diagnostic estimate represents and whether measurement dependence or classification uncertainty needs attention.
The case also shows why registry status and safety counts should be interpreted separately from efficacy or performance. TERMINATED is a status, not an explanation of the endpoint findings. The listed zero adverse-event counts are safety entries, not evidence about specificity. Each type of information answers a different question.
For statistical reading, the main lesson is to separate the protocol-level question from the evidence available in the results record. The question is clearly articulated; the numerical answer and its uncertainty are not. That distinction prevents design descriptions or planning assumptions from being mistaken for observed device performance.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation for interpretation is that the registry reports no primary endpoint result or analysis. Specificity is named and defined, but no estimate, denominator, confidence interval, or p-value is recorded. As a result, the central performance question cannot be quantified from the posted information.
The study is listed as single group, with allocation NA and masking NONE. The summary describes comparison with an FDA-cleared ECG monitor, but the registry does not explain the reference method, measurement pairing, interpretation procedures, or handling of discordant readings. These gaps prevent assessment of how the endpoint was operationalized and what comparison the result would represent.
The primary endpoint description notes that 1 subject was not analyzed due to an EDC error. The record does not give a full participant flow, define the analysis population, state the endpoint denominator, or describe missing and invalid measurements beyond this note. It is not possible to determine whether the analyzed observations would represent all enrolled participants.
The status is TERMINATED, but the reason and its relationship to data collection are not reported in the registry record. The listed start and primary-completion dates give registry milestones but do not explain the timing or completeness of participant measurements. The protocol, analysis plan, sample-size justification, and any interim analysis plans are not reported in the registry record.
The listed safety counts are limited to the categories and group recorded; follow-up duration and collection procedures are not described. These limitations do not demonstrate that the study had a particular flaw or that a particular result would have been obtained. They identify what cannot be assessed from the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection — NCT05476250.
- Registry record last updated 2025-05-13; status last verified 2025-04.
- Results first posted 2025-05-13.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes NCT05476250, titled Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection. It lists Masimo Corporation as sponsor, a single-group model, enrollment of 120, condition Healthy, allocation NA, and masking NONE. The study summary says noninvasive ECG measurements were to be compared with results from an FDA-cleared ECG monitor.
The primary endpoint is specificity of the device’s atrial fibrillation detection function, with a timeframe of 1-5 hours. Its description notes that 1 subject was not analyzed due to an EDC error. The registry lists one outcome measure and no analyses; no endpoint estimate is reported.
The recorded start is 2022-08-01, primary completion is 2022-08-10, and status is TERMINATED. The reason for termination is not reported in the registry record. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths for the device group. These entries do not provide the missing primary performance result.