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The PhysioGlove ES Model I is a reusable 12-lead diagnostic ECG examination system. The system can be used with 12-lead cables or the PhysioGlove device. When used with the PhysioGlove, it is intended to conduct an electrocardiogram. The diagnostic and automatic measurement features are not available. When used with a 12-lead cable, it is intended for use in resting diagnostic electrocardiograph examination of adults. The PhysioGlove ES Model I is intended for use in physician offices, hospitals, outpatient clinics, or similar settings by or on the order of a physician or similarly qualified healthcare professional. The device provides waveform parameters and ECG analysis for healthcare provider interpretation.

The PhysioGlove ES Model I ECG Analysis Program assists the physician in measuring and interpreting 12-lead EGGs for rhythm and contour information by providing an initial automated interpretation. Interpretation by the product is then confirmed, edited, or deleted by the physician. The analysis program is intended for use in the general population ranging from healthy subjects to patients with cardiac and/or non-cardiac abnormalities. The analysis program is intended for use in hospitals, outpatient clinics, emergency departments, and out-of hospital sites such as ambulances and patients' homes.

The PhysioGlove ES Model I is a diagnostic electrocardiograph for 12-Lead resting ECGs. The system consists of an electronics data acquisition unit and software that runs on a medical grade PC. The system uses either a standard, FDA-cleared, 10electrode EGG cable, or the PhysioGlove to obtain ECG data from the patient. The electronics performs analog processing and analog to digital conversion of a 12 lead diagnostic ECG.

The digital packets from the front-end enter the PC via the USB port. The software for the PC performs a variety of functions, including patient registration, ECG display, and storage.

In addition the system provides ECG analysis. The ECG Analysis Program is a software algorithm only. When the system is used with the PhysioGlove, the ECG Analysis Program is not available.

The PhysioGlove ES Module I is intended to be marketed in two configurations.

• Configuration 1 standard ES Model I without ECG analysis. .
• . Configuration 2 - standard ES Model I with ECG analysis.

The provided 510(k) summary for the Commwell Ltd. PhysioGlove ES Model I with ECG Analysis (K103791) does not contain detailed information about specific acceptance criteria and the study that proves the device meets these criteria for its ECG Analysis Program. This document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to general performance standards, rather than presenting a performance study with quantitative acceptance criteria against reported device performance.

Therefore, for aspects like acceptance criteria, reported device performance, sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, the document explicitly states:

• "There are no recognized consensus standards applicable to the ECG Analysis System algorithm."
• "The modifications made to the PhysioGlove ES Model I with ECG analysis did not require clinical testing to support substantial equivalence."

This indicates that a specific performance study with detailed acceptance criteria and reported metrics, as you've requested, was not part of this particular submission for the ECG Analysis Program. The submission relies on the substantial equivalence to the GE 12SL ECG Analysis Program (K092369), which implies that the performance characteristics of the GE program are assumed to be met or are sufficient for the intended use.

However, I can extract the available information and highlight what is mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Not explicitly stated for the ECG Analysis Program's performance. The submission indicates that "clinical testing" was not required for substantial equivalence of the modifications for the ECG analysis. Instead, it refers to the predicate device (GE 12SL ECG Analysis Program, K092369) for this functionality.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not explicitly stated. No specific performance study with expert-established ground truth is detailed for this submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not explicitly stated. No specific performance study is detailed.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, an MRMC comparative effectiveness study was not done as part of this submission. The document states: "The modifications made to the PhysioGlove ES Model I with ECG analysis did not require clinical testing to support substantial equivalence." The role of the analysis program is described as providing "an initial automated interpretation" to be "confirmed, edited, or deleted by the physician," but no study on physician improvement with or without the AI is provided.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not explicitly stated in terms of a formal performance study. While the ECG Analysis Program is a "software algorithm only," and its output is an "initial automated interpretation," the submission does not provide data on its standalone performance (e.g., sensitivity, specificity for specific cardiac conditions) against a ground truth.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not explicitly stated. Since no specific performance study is detailed, the method for establishing ground truth for any potential internal testing is not provided.

8. The sample size for the training set:

• Not explicitly stated. There is no information about the training data for the ECG Analysis Program, as the device is incorporating the GE 12SL ECG Analysis Program.

9. How the ground truth for the training set was established:

• Not explicitly stated. This information would typically be part of the documentation for the GE 12SL ECG Analysis Program, which is a predicate device.

In summary:

This 510(k) submission for the Commwell PhysioGlove ES Model I with ECG Analysis primarily demonstrates substantial equivalence by leveraging the pre-established approval of the GE 12SL ECG Analysis Program (K092369) and the PhysioGlove ES Model I (K050674). It does not present new, detailed performance study data for the ECG analysis algorithm against specific quantitative acceptance criteria. Instead, it focuses on software verification, validation, and compliance with general safety and performance standards, concluding that "there are no new questions of safety and effectiveness issues."

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