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.

Device Description

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.

AI/ML Overview

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:

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with software verification and validation	"Software Verification and Validation" was performed.
Performance testing of the system	"Performance testing" was performed.
Usability in the intended environment	"Usability testing was done to demonstrate the efficacy of the PhysioGlove in its intended environment."
Compliance with IEC 60601-1-4 (Programmable Medical Systems)	The device "compl[ies] with the Guidances and/or Special Controls" and lists this standard.
Compliance with IEC 62304 (Software Life Cycle for Medical Devices)	The device "compl[ies] with the Guidances and/or Special Controls" and lists this standard.
Compliance with IEC 60601-2-51 (Safety of Electrocardiographs)	The device "compl[ies] with the Guidances and/or Special Controls" and lists this standard.
Overall Functionality	"In all instances, the device functioned as intended."
Assistance to physician in interpreting 12-lead ECGs (Implied by Intended Use)	The analysis program "assists the physician in measuring and interpreting 12-lead ECGs for rhythm and contour information by providing an initial automated interpretation."

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."

Summary

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510(k) Summary

Commwell Ltd. PhysioGlove ES Model I with ECG Analysis

510(k) Number K103791

Date:

October 18, 2011

Submitter:

Commwell Ltd. Rechov Yad Harutzim 4 Kfar Saba, Israel 44641

Contact Person:

Irving Levy Commwell Ltd. · Rechov Yad Harutzim 4 Kfar Saba, Israel 44641 T: (972) 9-766-8094 F: (972) 9-766-8099

Device Trade Name:

PhysioGlove ES Model I with ECG Analysis

Common Name:

12-lead Diagnostic System with ECG Analysis Program

Classification:

Electrocardiograph System

Product Code:

DPS, MHX

Class:

CFR Reference:

21 CFR 870.2340

Predicate Devices:

K050674, Commwell PhysioGlove ES Model I .
K092369, GE 12SL ECG Analysis Program .

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Intended Use / Indications for Use:

Device Description:

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.

Technological Characteristics - Components and Safety Features:

The PhysioGlove ES Model I with ECG analysis is for recording and analyzing diagnostic 12-lead ECG signals. The system is intended to be used with either a standard patient cable or the cleared PhysioGlove device (K083677). When used

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with the PhysioGlove, the ECG analysis functionality is disabled. The system employs the same functional scientific technology as its predicate devices.

Determination of Substantial Equivalence:

The PhysioGlove ES Model I with ECG analysis has been modified from the predicate version (K050674) to include additional features to enhance performance and usability of the device, and to provide additional functionality with the introduction of the ECG analysis package (General Electric (GE) 12SL ECG Analysis Program approved under (K092369)). There have been no changes to the fundamental scientific technology of the system.

Summary of Non-Clinical testing:

There are no recognized consensus standards applicable to the EGG Analysis System algorithm. The EGG Analysis Program and its applications comply with the Guidances and/or Special Controls as outlined below and detailed in Section 16 of this premarket submission. The following quality assurance measures were applied to the development of the system:

*Requirements Reviews .
*Risk Analvsis .
*Software Verification and Validation .
*Performance testing .

The device was tested according to the following performance standards:

Usability testing was done to demonstrate the efficacy of the PhysioGlove in its . intended environment.
IEC 60601-1-4 Programmable Electrical Medical Systems .
IEC 62304 Software Life Cycle for Medical Devices .
IEC 60601-2-51 Particular requirements for safety of electrocardiographs .

In all instances, the device functioned as intended.

Summary of clinical testing:

The modifications made to the PhysioGlove ES Model I with ECG analysis did not require clinical testing to support substantial equivalence.

Conclusion:

The summary above shows there are no new questions of safety and effectiveness issues associated with the PhysioGlove ES Model I with ECG analysis when compared to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 2 1 2011

Crommwell Ltd. c/o Mr. Irving Levy Vice President Rechov Yad Harutzim4 Kfar Saba ISRAEL 44641

Re: K103791

Trade/Device Name: PhysioGlove ES Model I with ECG Analysis Program Regulatory Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: II (two) Product Code: 74 DPS Dated: September 21, 2011 Received: September 21, 2011

Dear Mr. Levy:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have betely promance holdication of intent to market the device
for use stated in the enclosure) to locally market is substantially equivalent (for the i for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of the Federal Food, Drug,
You may, therefore, market the device, subicat to You may, therefore, market the device, subject to the general controls provisions of the Act. The Act. The general controls provisions of the Act include requirements for annual registration, isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Irving Levy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Rev. D. Zacharias, M.P.

Bram D. 2 uckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number: K103791

Device Name:

PhysioGlove ES Model I with ECG Analysis Program

Indications for Use:

The PhysioGlove ES Model I ECG Analysis Program assists the physician in measuring and interpreting resting 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.

Prescription Use (Per 21 CFR 801.109 subpart D)

Over the Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Qffice of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K103791

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).