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 Form, Fit, and Function of INVSENSOR00061 (NCT05926648), a na na study. The primary outcome is INVSENSOR00061 SpO2 Accuracy.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT05926648 |
| Phase | NA |
| Condition | Healthy |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Masimo Corporation |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned healthy newborn and infant subjects aged 0–18 months. The registry record lists 53 enrolled subjects. It also states that 11 subjects were not included in the endpoint analysis because of incorrect sensor placement, and 29 were not included because a reference sensor needed for the calculation was absent. Whether those exclusions overlap is not reported in the registry record.
Intervention
The device under evaluation was the noninvasive INVSENSOR00061. The record describes the test subjects as receiving this device and states that its form, fit, and function were evaluated. The study was not registered as a comparison between different devices or treatments.
Comparator
No concurrent comparator group is described. The allocation is listed as NA, and the study model is single group. Reference values were used in calculating the accuracy endpoint, but those values are not a randomized control arm. The source and details of the reference measurement beyond the reference sensor are not reported in the registry record.
Primary question
The registered primary question was whether INVSENSOR00061’s SpO2 measurements agreed with reference values, summarized by an accuracy root mean squared difference (Arms) over a timeframe of 2 hours. The registry record describes the calculation in accordance with ISO-80601-2-61. It does not report a numerical Arms result, an uncertainty interval, or an analysis result, so the degree of agreement cannot be assessed from the record.
3. Trial Design
This completed study was registered as a single-group evaluation of the form, fit, and function of INVSENSOR00061. Its stated objective concerned use on newborn and infant subjects aged 0–18 months, and the condition listed was Healthy. The intervention was a noninvasive device. The sponsor was Masimo Corporation.
The registry lists enrollment as 53. Allocation is NA, masking is NONE, and the model is SINGLE GROUP. These design entries indicate that the registered study was not a randomized, masked comparison between treatment arms. The record does not describe a concurrent control group. The reference measurements used for the primary accuracy calculation serve a different role: they are inputs to the agreement measure, not an allocated comparator arm.
The recorded study start was 2023-05-12, primary completion was 2024-03-28, and status is COMPLETED. Phase is listed as NA. These administrative entries describe the registered study but do not supply further detail about procedures, follow-up beyond the endpoint timeframe, or the timing and conduct of analysis.
The primary endpoint was INVSENSOR00061 SpO2 Accuracy, with a stated timeframe of 2 hours. The record says that the measure was derived from the difference between measured SpO2 values and reference values. It also identifies subjects excluded from the endpoint analysis because of incorrect sensor placement or absence of a reference sensor. The record does not give a numerical outcome, a breakdown of the analysis population, or an account of any overlap between those exclusion reasons.
Because the design is single group, it can describe device measurements relative to the stated reference method, if outcome results are reported. It cannot by itself estimate a comparative effect against a separately assigned control group. The registry record does not report a sample-size justification, further protocol details, or a statistical analysis plan.
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 | Test Subjects |
|---|---|
| STARTED | 53 |
| COMPLETED | 52 |
| NOT COMPLETED | 1 |
Analysis population for the primary outcome, as defined in the registry: 11 subjects not included in analysis due to incorrect sensor placement. 29 subjects not included in analysis due to absence of reference sensor used to calculate Arms.
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 | Test Subjects |
|---|---|---|
| Participants analysed | 52 | |
| Age, Categorical: <=18 years | Participants | 52 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 |
| Age, Categorical: >=65 years | Participants | 0 |
| Sex: Female, Male: Female | Participants | 28 |
| Sex: Female, Male: Male | Participants | 24 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 21 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 1 |
| Race (NIH/OMB): White | Participants | 15 |
| Race (NIH/OMB): More than one race | Participants | 3 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 12 |
| Region of Enrollment: United States | participants | 52 |
6. Primary Endpoint
The registry lists the primary outcome as INVSENSOR00061 SpO2 Accuracy, measured over 2 hours.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | % of SpO2 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is titled INVSENSOR00061 SpO2 Accuracy and is expressed as % of SpO2. The registry describes it as an accuracy root mean squared difference (Arms) between device-measured values and reference values, calculated in accordance with ISO-80601-2-61. The registered timeframe is 2 hours.
In general, an aggregate root mean squared difference summarizes the size of discrepancies between paired measurements. Squaring the individual differences prevents positive and negative discrepancies from cancelling one another; the resulting summary reflects the magnitude of disagreement rather than its direction. A smaller value would generally indicate closer agreement with the reference values, although no numerical result is reported in this record.
Agreement with a reference measurement is a distinct question from whether readings differ between treatment groups. This endpoint is intended to characterize measurement accuracy for the device in the study context, not a clinical outcome or a treatment effect. The registry record refers to reference values and a reference sensor, but it does not report the reference method’s further characteristics, the observed Arms value, or an uncertainty interval. It states that 11 subjects were excluded from the analysis because of incorrect placement and 29 because the reference sensor needed for the calculation was absent. The extent to which the recorded exclusions affected the endpoint estimate cannot be assessed from the record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a single primary endpoint and gives its calculation method and timeframe, but it does not report the endpoint’s numerical result. It also lists zero analyses. Consequently, no estimate of SpO2 accuracy, test statistic, p-value, or confidence interval is available in the registry record. Without an observed Arms value, the size and precision of any device-to-reference discrepancy cannot be evaluated from these entries.
The endpoint is an agreement measure, not a comparison of randomized groups. In general, a root mean squared difference condenses discrepancies across paired readings into one summary. Its interpretation depends on the values included, how readings were paired, the reference method, and the analysis population. The registry describes these measurements as being handled in accordance with ISO-80601-2-61, but does not provide the numerical findings or further analysis details needed to judge the result.
The listed enrollment is 53. The endpoint population statement says 11 subjects were not included in analysis because of incorrect sensor placement and 29 were not included because a reference sensor was absent. The record does not state whether the categories overlap, provide a final analysis count, or explain how missing reference measurements were handled beyond those exclusions. Those omissions limit assessment of how representative the analyzed measurements were of enrolled subjects.
The study’s single-group structure also constrains interpretation. Reference values make the accuracy calculation possible, but they do not create a randomized control arm. The record therefore does not support a between-group treatment comparison. Nor does a device accuracy endpoint, on its own, establish effects on clinical outcomes. The registry describes evaluation of form, fit, and function, but the available primary endpoint information concerns only SpO2 measurement accuracy.
The safety entries list zero serious adverse events, zero other adverse events, and zero deaths in the Test Subjects group, with 53 at risk for each event category. These are the values recorded in the adverse-event fields; they do not substitute for the absent accuracy result. The record does not provide further safety descriptions or serious adverse event terms.
Overall, the registry establishes the study’s intended measurement question, general design, and some exclusions, but not the outcome needed to answer that question. It is therefore not possible to determine from the record whether measured SpO2 values were close to the reference values, how variable agreement was, or how uncertainty around the estimate should be interpreted.
9. Statistical Methods Explained
The registered endpoint is a measurement-agreement statistic. The record calls it an accuracy root mean squared difference (Arms) and says it was calculated from INVSENSOR00061 measurements and reference values in accordance with ISO-80601-2-61. In general, this kind of summary begins with paired readings, calculates their differences, squares those differences, and aggregates them into a single measure of discrepancy. Squaring means that discrepancies in either direction contribute positively to the summary; larger discrepancies have greater influence than smaller ones. A root mean squared measure is commonly interpreted on the scale of the original measurements.
The registry includes a mathematical expression for the Arms calculation, but it does not report the resulting value. The endpoint unit is listed as % of SpO2, and its timeframe is 2 hours. The record does not give the number of paired readings, their distribution, or the numerical summary. It also does not describe any confidence interval or other measure of uncertainty. In general, an estimate describes the observed magnitude, while an uncertainty interval communicates how precisely that magnitude has been estimated. Without the estimate and uncertainty information, neither the size nor precision of agreement can be judged.
For a measurement-agreement analysis, the reference procedure is important because the statistic summarizes device readings relative to that reference. The registry states that reference values were used and that a reference sensor was required for the calculation. It does not report further details about the reference sensor, reference readings, pairing rules, or any quality-control procedures. It identifies 29 subjects as not included in analysis because of absence of the reference sensor. Incorrect sensor placement is given as the reason for excluding 11 subjects. The record does not say whether these reasons overlap or how the exclusions affected the final analysis population.
The design information is also relevant to interpretation. The model is single group, allocation is NA, and masking is NONE. This is not a randomized comparison between groups. The reference values are part of the accuracy calculation rather than observations from a separately allocated control arm. In general, a single-group measurement study can describe device-to-reference agreement under its study conditions, but it cannot provide a randomized treatment contrast. The registry record does not report a separate comparator group or a comparative statistical analysis.
The record lists one outcome measure and zero analyses. It does not report a numerical Arms result, statistical test, p-value, confidence interval, adjustment, or detailed analysis plan. The absence of a reported p-value should not be interpreted as evidence that a statistical test found no difference; the registry record simply does not include an analysis result. Likewise, the absence of an interval means precision cannot be evaluated, not that the estimate is exact.
Planning calculations require particular care. The registry’s stated sample-size assumptions describe an illustration based on an observed effect, using a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The assumptions say that the effect to detect is a stated fraction of the observed effect. Those assumptions do not describe the registered single-group design, and the record does not report the numerical observed effect needed to interpret such an illustration. Any sample-size values based on those assumptions would be planning illustrations, not observed power or evidence that the study was designed around those parameters. A sample-size justification for the actual study is not reported in the registry record.
In general, a confidence interval around a measurement-agreement estimate would help show the range of values compatible with the data and the analysis assumptions. Its width depends on information such as the number and variability of usable paired measurements and the analysis method. None of those interval results is reported in the registry record. General statistical principles cannot fill in the absent result or establish how accurately the device measured in this study.
Over-dispersion is relevant to count outcomes when variability exceeds what a simple count model assumes; it can make standard errors too small if ignored. That concept does not supply an analysis for this endpoint, which is a continuous measurement-agreement summary rather than a reported count comparison. The registry record does not describe an over-dispersion analysis, a model for the endpoint, or any statistical adjustment. The appropriate reading is therefore limited to the endpoint definition and design information actually recorded, without assuming a model or inferential procedure that is not reported.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure, identified as the primary SpO2 accuracy endpoint, and zero analyses. It does not report numerical results for that endpoint or any secondary outcome analyses. A multiplicity adjustment or hierarchy of statistical tests is not reported in the registry record. With no analysis results, it is not possible to assess whether multiple testing affected interpretation.
The record identifies two reasons that subjects were not included in the endpoint analysis: incorrect sensor placement for 11 subjects, and absence of a reference sensor for 29 subjects. It does not state whether the categories overlap, provide the number of usable paired measurements, or report a final analysis population. It also does not describe imputation, sensitivity analyses, or another approach to missing reference values. Those details are not reported in the registry record.
In general, exclusions and missing measurements can affect an estimate when the availability or usability of data is related to the measurements or participant characteristics. The registry does not provide enough information to determine whether that occurred. It also does not report an analysis population definition beyond the stated exclusions. The endpoint result itself is absent, so the direction or size of any potential impact cannot be evaluated.
A statistical analysis plan, including any prespecified handling of missing data, is not reported in the registry record. No assumptions about the analysis population or missing-data procedure should therefore be inferred from the endpoint description alone.
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 |
|---|---|---|---|
| Test Subjects | 0 | 53 | 0.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Test Subjects | 0 of 53 |
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 |
|---|---|
| Test Subjects | 0 of 53 |
The adverse-event record lists one group, Test Subjects. For serious adverse events, 53 are listed as at risk and 0 as affected. For other adverse events, 53 are listed as at risk and 0 as affected. Deaths are listed as 0. No serious adverse event terms appear in the record.
These entries describe the values recorded in the registry’s safety fields. They do not provide event narratives, severity details beyond the serious-event category, or information about how events were collected and reviewed. Zero recorded events should be read as a registry entry, not as proof that no event of any kind occurred outside the recorded categories or reporting process. The record does not report further safety follow-up details.
These safety figures are separate from the primary accuracy endpoint. They do not quantify measurement agreement, and they do not resolve the absence of a numerical Arms result. Since the study is single group and has no registered comparator, the safety entries also do not provide a comparative estimate between groups.
12. What the Result Does, and Does Not, Mean
The registry record establishes that INVSENSOR00061 was evaluated in a completed, single-group study of healthy newborn and infant subjects aged 0–18 months. It identifies the primary measurement question as SpO2 accuracy relative to reference values, summarizes the endpoint as an Arms measure, and gives a timeframe of 2 hours. It also records exclusions related to incorrect sensor placement and absence of a reference sensor.
What the record does not establish is the observed magnitude of agreement. No numerical Arms value, uncertainty interval, or analysis result is reported, and the analysis count is listed as 0. As a result, the available record cannot show how close the device measurements were to the reference values or how precisely any estimate was determined. The stated endpoint and calculation method describe what was intended to be measured; they are not themselves findings.
The single-group design means that the study is not a randomized comparison with a separate control group. The reference values are necessary to form the accuracy measure, but they should not be interpreted as a treatment arm. The record therefore cannot establish comparative effects between groups. It also does not report clinical outcomes that would answer broader questions about health effects.
The safety fields list zero serious adverse events, zero other adverse events, and zero deaths, with 53 at risk in each event category. These are registry entries, not a substitute for the missing accuracy result or a full account of event ascertainment. Similarly, the stated exclusions flag potential limits on endpoint data availability, but the registry does not report enough detail to determine their effect on the result.
The most supportable conclusion is narrow: the registry describes a device measurement study and its planned accuracy endpoint, but the posted outcome information is insufficient to characterize the observed accuracy or its precision. No conclusion about the magnitude of measurement agreement can be drawn from the endpoint label alone.
13. Why This Trial Matters Statistically
This study raises a useful statistical distinction between measurement accuracy and comparative effectiveness. Its primary endpoint is based on differences between device readings and reference values, while its design is single group. That structure is suited to describing agreement with a reference under the study conditions when results are available; it is not a randomized comparison of treatments.
The endpoint also illustrates why a summary measure needs a reported estimate and context. A root mean squared difference compresses many paired discrepancies into one value. As a general statistical matter, the summary’s magnitude and precision matter for interpretation, as do the reference method and the measurements included. The registry provides the endpoint definition but not the numerical result, uncertainty interval, or detailed information about the usable readings. The study question is therefore clear, but the recorded outcome information does not allow the reader to judge its answer.
Data availability is another important feature. The record identifies incorrect sensor placement and an absent reference sensor as reasons for excluding subjects from analysis. In general, such exclusions can affect how well an estimate represents the enrolled study population, depending on why data are unavailable. Because the record does not report overlap, an analysis count, or sensitivity analyses, that issue cannot be resolved from the registry entries.
Finally, the listed sample-size assumptions describe a two-arm planning illustration, whereas the registered study is single group. This contrast underscores why planning assumptions should not be mistaken for the actual design or for observed evidence. The registry does not report the numerical outcome needed to connect those assumptions to an observed effect. The statistical importance of the study lies in the measurement question it set out to address, alongside the limits imposed by the absent result and incomplete analysis detail.
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 of the registry record is that it does not report the numerical result for the primary endpoint. The record lists one outcome measure and zero analyses, so the observed Arms estimate, its uncertainty, and any inferential result are unavailable. This prevents evaluation of both the amount of device-to-reference discrepancy and the precision of the estimate.
The single-group design has no separate randomized comparator. Reference values contribute to the accuracy calculation but are not a control arm. Accordingly, the record does not support a between-group comparison. Masking is listed as NONE, and allocation is NA; further details on measurement procedures and data review are not reported in the registry record.
The analysis population is not fully described. The registry states that 11 subjects were excluded because of incorrect sensor placement and 29 because the reference sensor was absent, but does not report whether these reasons overlap, the final number analyzed, or the impact of exclusions. The number of paired readings and the handling of missing reference measurements are also not reported.
The record does not provide an uncertainty interval, a detailed statistical analysis plan, or a sample-size justification for the registered design. Its sample-size assumptions describe a two-arm planning illustration, not the single-group design. The reference sensor’s further characteristics and details of the endpoint calculation beyond the registered description are not reported. These limitations restrict interpretation to the study objective, registered endpoint, design entries, exclusions, and recorded safety fields.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Form, Fit, and Function of INVSENSOR00061 — NCT05926648.
- Registry record last updated 2024-09-25; status last verified 2024-09.
- Results first posted 2024-09-25.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT05926648, titled Form, Fit, and Function of INVSENSOR00061, is listed as completed. The study was sponsored by Masimo Corporation and enrolled 53 subjects. It concerned healthy newborn and infant subjects aged 0–18 months and evaluated the noninvasive INVSENSOR00061 in a single-group design. Allocation is NA, masking is NONE, and phase is NA.
The primary endpoint was INVSENSOR00061 SpO2 Accuracy, described as an Arms difference between measured and reference values, with a timeframe of 2 hours. The registry states that 11 subjects were excluded for incorrect sensor placement and 29 for absence of a reference sensor. A numerical endpoint result and analysis result are not reported in the registry record.
The safety fields list zero serious adverse events, zero other adverse events, and zero deaths in the Test Subjects group. The record does not report a comparative control group, a sample-size justification for the registered design, or further analysis details.