Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 (NCT06071754), a na na study. The primary outcome is Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057.

2. Clinical Question

This is a measurement-validation question, not a question about treatment effects. The record identifies the intended signal and clinical uses but does not specify the exact validation criterion, the reference measurement, or how correspondence was to be assessed. Those details are important for interpreting any device performance estimate and are not reported in the registry record.

3. Trial Design

This was a completed, single-group device study sponsored by Masimo Corporation. The registry lists an enrollment of 365 and one arm, in which all subjects were to have ECG measurements obtained using the INVSENSOR00057. Allocation is listed as not applicable, and the record identifies the study as not randomized. Masking is listed as none. The study is therefore not a randomized comparison, and its arm should not be read as one side of a like-for-like control comparison.

The stated objective was to validate the ECG function against contemporaneous measurements. The device function is described as a single lead, similar to lead I, intended for heart rate measurement and AFib detection. The primary outcome timeframe is approximately 30 minutes. The registry lists healthy participants and participants with atrial fibrillation as the conditions of interest, but does not provide a fuller account of recruitment, eligibility, or how participants were distributed across rhythm groups.

The recorded study start was 2023-09-01, and primary completion was 2024-04-30. The status is completed. The record lists one outcome measure and no analysis results. Although it describes the purpose of validation, it does not report the detailed measurement protocol, the reference method, the planned performance criterion, or the statistical analysis plan. Sample-size justification and information about interim analyses are not reported in the registry record.

Because this is a single-group design, the study description supports framing the question as measurement validation rather than as a comparison of treatments or randomized groups. The contemporaneous measurements are part of the stated objective, but the registry does not identify them as a separate trial arm or explain how paired measurements were analyzed.

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

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: Masimo W1 rhythm classifications were not obtained from 9 subjects (3 from the NSR group, 6 from AFib group) due to the subject not completing the protocol.

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.

6. Primary Endpoint

The registry lists the primary outcome as Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057, measured over Approximately 30 minutes.

The primary outcome is titled Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057. Its description specifies a single-lead ECG similar to lead I, intended to be used for heart rate measurement and AFib detection. The timeframe is approximately 30 minutes, and the listed unit is percent. The outcome is recorded as a number, but the registry does not define the numerator, denominator, or exact quantity expressed as a percentage.

This type of endpoint is relevant to a device-validation study because the central purpose is to assess how measurements from the device relate to contemporaneous measurements. For such an assessment, the exact reference method and the definition of acceptable performance are essential: a percentage could represent different quantities depending on those definitions. Neither the detailed reference method nor a performance threshold is reported in the registry record.

The registry also notes that Masimo W1 rhythm classifications were not obtained from 9 subjects—3 from the NSR group and 6 from the AFib group—because those subjects did not complete the protocol. It does not report how those missing classifications were handled in the primary outcome analysis. No numerical primary outcome result or analysis estimate is reported in the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

What a validation analysis generally asks. In general, device validation assesses whether measurements from a new device correspond sufficiently well to measurements from a specified reference method for an intended use. This is different from asking whether an intervention changes a clinical outcome. The registry’s stated objective is validation against contemporaneous measurements, but the reference method and the specific statistical criterion are not reported in the registry record. The exact method matters because correlation, agreement, sensitivity, and classification accuracy answer different questions. No particular one of these methods should be assumed for this study.

Why the endpoint definition matters. In general, a percentage is interpretable only when its numerator and denominator are defined. A percentage could describe correct classifications, available measurements, or another quantity; each would have a different interpretation. The registry lists the outcome as a number with percent as its unit, but does not define the counted event or the denominator. It also does not report a threshold that would distinguish acceptable from unacceptable performance. As a result, the endpoint’s statistical estimand—the precise quantity the analysis is intended to estimate—is not clear from the registry record.

Agreement and classification are not interchangeable. In general, two measurement methods can be associated without agreeing closely: values may move together while differing systematically. Agreement analyses examine how far paired measurements differ, while classification analyses assess whether a device assigns categories correctly against a reference. For a rhythm-detection use, classification performance could be expressed in several ways, each emphasizing a different error pattern. For a heart-rate measurement use, the relevant validation question may instead concern the numerical values. These are general distinctions, not reported analyses for this study. The record does not say which approach was used or whether separate analyses addressed the intended uses.

Uncertainty and confidence intervals. In general, a confidence interval describes the uncertainty around an estimated quantity under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while the estimate itself describes the observed performance under the chosen definition. A confidence interval does not establish that a device meets a clinical or technical criterion unless that criterion is defined and interpreted alongside the interval. No confidence interval or numerical estimate is reported in the registry record, so precision cannot be assessed from the registry entries.

Population and missing classifications. The registry reports that classifications were not obtained from 9 subjects who did not complete the protocol: 3 from the NSR group and 6 from the AFib group. In general, missing outcome information can affect both the number of observations included and the interpretation of an estimate. The implications depend on why data are missing and on how missingness relates to the outcome. Here, protocol noncompletion is the stated reason, but the registry does not report the analysis population, the handling of these missing classifications, or whether additional outcomes were missing. No assumption about the missingness mechanism or analysis method is warranted.

Single-group design and comparison. In general, a single-group device study can collect measurements from a device and compare them with a reference without randomizing participants to separate arms. A paired comparison may be suitable when both methods measure the same participant at a similar time, but the analysis must account for the pairing and define the reference. The objective’s reference to contemporaneous measurements suggests that measurements were intended to be related in time; the detailed protocol and analysis are not reported. The arm description says all subjects were enrolled into one arm, so it should not be interpreted as a randomized control comparison.

Planning illustrations and power. In general, a sample-size calculation is a planning tool based on assumptions about the outcome, target effect, variability, allocation, and error rates. It does not establish what was observed. A planning illustration based on an observed effect is retrospective and is not observed power; it cannot substitute for the estimate and its uncertainty. The registry record does not report the study’s sample-size justification. The assumptions stated for planning illustrations include a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect defined as a stated fraction of the observed effect. Those are planning assumptions, not a description of this single-group study’s design or evidence of a study-specific analysis.

Multiplicity and analysis transparency. In general, testing multiple outcomes, subgroups, or decision thresholds can increase the chance of a false-positive result if the analysis does not account for those multiple opportunities. A prespecified analysis plan helps readers distinguish confirmatory questions from exploratory ones. The registry lists one primary outcome measure and no analyses, but does not report a statistical analysis plan, subgroup analyses, adjustment for multiplicity, or interim analyses. Their use or absence cannot be inferred from the available record.

Over-dispersion as a general consideration. In general, over-dispersion occurs when count variability exceeds what a statistical model assumes. If present, it can make standard errors and confidence intervals too small when the model does not account for it. This concept is relevant only when the outcome and model warrant it; the registry does not specify a count model or report data that would allow over-dispersion to be assessed. It should not be read as a feature established for this study.

10. Multiplicity, Missing Data and Analysis Populations

The registry lists one primary outcome measure, but it does not report an analysis plan or any analysis results. It does not describe whether there were additional prespecified endpoints, subgroup analyses, multiple performance thresholds, or adjustments for multiple testing. The number of listed outcomes alone does not establish how many statistical comparisons were planned or conducted. Multiplicity procedures are not reported in the registry record.

For missing information, the outcome note states that Masimo W1 rhythm classifications were not obtained from 9 subjects because they did not complete the protocol: 3 from the NSR group and 6 from the AFib group. The record does not give an analysis population or state how those classifications were handled. It also does not report whether these subjects had other measurements available, whether any imputation was used, or whether the primary analysis included only subjects with complete classifications. Those details are needed to understand the analysis denominator and the potential influence of missing data.

In general, the reasons for missing data and the chosen analysis approach can affect both estimates and their uncertainty. The stated reason is protocol noncompletion, but no further information is provided to assess whether the unavailable classifications could be related to the measured performance. A missing-data assumption or sensitivity analysis should not be attributed to the study without documentation.

The record does not describe interim analyses, stopping rules, or the analysis populations used for safety and performance outcomes. These matters are not reported in the registry record.

11. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 0% reporting threshold.

The safety entries list 365 participants at risk for serious adverse events and 0 affected; they also list 365 at risk for other adverse events and 0 affected. Deaths are listed as 0, and no top serious adverse-event terms are listed. These entries describe the event counts recorded in the registry; they do not provide detailed event narratives or a comparison with another group.

Zero reported events means that the record lists no events in those categories for the stated at-risk group. It is not a demonstration that the risk is absent, nor does it establish comparative safety. The record does not provide additional details about the method of event collection, the observation period for safety, or how adverse events were attributed. The primary outcome timeframe is approximately 30 minutes, but that timeframe should not be assumed to define the safety observation period.

This is a single-group study, not a randomized comparison. The event figures therefore should be read as descriptive counts, rather than as evidence of a difference between treatments or devices. The registry’s safety entries do not by themselves quantify uncertainty about event rates, and no safety analysis estimate is reported.

12. What the Result Does, and Does Not, Mean

The registry record documents a completed study designed to evaluate the ECG function of the Masimo INVSENSOR00057 against contemporaneous measurements. It identifies the device as a single-lead ECG similar to lead I and describes heart rate measurement and AFib detection as intended uses. It also reports enrollment of 365 and notes that rhythm classifications were unavailable for 9 subjects who did not complete the protocol.

Those design details establish what the study set out to examine, but they do not establish the degree of measurement performance. The registry gives no numerical result for the primary outcome, no confidence interval, and no defined performance threshold. The meaning of the listed percent unit is also unclear because the numerator and denominator are not described. The reference measurement and the analysis method are not reported in the registry record.

The results therefore do not support a statistical conclusion about whether the device met a validation criterion, how precisely any performance was estimated, or whether performance differed between NSR and AFib classifications. No group-specific estimate or analysis is reported. The missing classifications also make the analysis population and handling of missing outcomes important unknowns.

These limitations do not establish that the device succeeded or failed. They delimit what can be concluded from the registry entry: the study objective, broad design, outcome description, and safety counts are recorded, while the key analysis results needed to judge performance are not. Interpreting validation requires the estimate, its uncertainty, the comparator definition, and the prespecified criterion—not design information alone.

13. Why This Trial Matters Statistically

Device-validation studies address a statistical question distinct from treatment trials: whether measurements from a device are sufficiently informative relative to a defined reference for an intended use. That question depends on clear measurement definitions, an appropriate comparator, and a method matched to the intended claim. The record identifies an ECG function aimed at heart rate measurement and AFib detection, making endpoint interpretation central to understanding the study.

This study is also a useful example of why a completed status and an enrollment figure are not substitutes for results. The registry reports enrollment of 365 and one primary outcome measure, but does not include an analysis result. Without a defined percentage, reference method, and uncertainty estimate, readers cannot determine what the outcome represents statistically or how precisely performance was estimated. Transparent reporting of those elements is important for evaluating measurement evidence.

The missing rhythm classifications matter for the same reason. The record states that classifications were unavailable for 9 subjects due to protocol noncompletion, but does not describe the endpoint analysis population or missing-data handling. In validation work, a clear account of which measurements contribute to each estimate helps readers understand both the target population and the scope of the result.

Finally, the single-group structure matters when interpreting comparisons. The study is not a randomized comparison between arms; its stated objective is validation against contemporaneous measurements. Distinguishing those designs prevents readers from treating a device-versus-reference assessment as a randomized treatment contrast. The registry record provides the study’s broad purpose but lacks the statistical results needed to resolve the performance question.

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 main limitation for interpretation is that the registry record contains no analysis results. It lists one primary outcome but does not report a numerical estimate, uncertainty interval, or test result. The outcome is expressed with a percent unit, but the exact quantity represented by that percentage is not defined.

The reference method is also unspecified beyond the objective’s phrase contemporaneous measurements. The record does not identify the comparator device or method, describe how measurements were paired, or report the criterion for acceptable performance. Without these details, the intended validation question cannot be translated into a defined statistical estimand from the registry entry.

The study is recorded as single group, with all subjects in the device arm and no masking. This is not a randomized control comparison. The registry also does not give a detailed description of the participant groups or the number included in each analysis. It notes unavailable classifications for 9 subjects—3 from the NSR group and 6 from the AFib group—because they did not complete the protocol, but does not state how those missing classifications were handled.

Other relevant information is not reported in the registry record, including the statistical analysis plan, sample-size justification, interim analyses, multiplicity procedures, and analysis populations. The safety entries are descriptive counts and do not provide a comparison group or detailed event-collection information. These omissions constrain assessment of performance, precision, missing-data impact, and safety interpretation; they do not indicate a particular device result.

15. Related Tutorials

16. Related Statistical Calculators

17. Sources

• ClinicalTrials.gov: Validation of the Performance of the Electrocardiogram (ECG) Function in the Masimo INVSENSOR00057 — NCT06071754.
• Registry record last updated 2025-10-31; status last verified 2025-10.
• Results first posted 2025-06-12.
• 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.

18. Record Summary

The record for NCT06071754 describes a completed, single-group study sponsored by Masimo Corporation. It lists an enrollment of 365, a start date of 2023-09-01, and primary completion on 2024-04-30. All subjects were enrolled in the INVSENSOR00057 arm and were to have ECG measurements obtained.

The objective was to validate the device’s ECG function against contemporaneous measurements. The single-lead ECG is described as similar to lead I and intended for heart rate measurement and AFib detection. The primary outcome timeframe is approximately 30 minutes, and its unit is percent. The record lists one outcome measure but no analysis results.

Masimo W1 rhythm classifications were not obtained from 9 subjects who did not complete the protocol: 3 from the NSR group and 6 from the AFib group. Safety entries list 0 serious adverse events, 0 other adverse events, and 0 deaths. The endpoint definition, reference method, analysis population, and performance results are not reported in the registry record.