The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram. It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms).

Device Description

The PhysioGlove is a glove that incorporates a system of Ag/AgCI electrodes for use in recording ECGs. The glove terminates in a standard 15-pin mini D-type connector. The PhysioGlove is intended to be used with the cleared PhysioGlove ES-1 software, for recording diagnostic 12-lead ECGs.

AI/ML Overview

The provided text describes the PhysioGlove, an ECG electrode glove, and its regulatory clearance. However, it does not contain specific acceptance criteria or a detailed study proving the device meets particular performance metrics beyond general statements of efficacy and compliance with broad standards.

Therefore, many of the requested sections cannot be filled with information directly from the provided text.

Here's an attempt to answer based on the available information:

Acceptance Criteria and Device Performance Study for PhysioGlove (K083677)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Comments
Clinical Efficacy: Ability to conduct an electrocardiogram comparable to a standard 12-lead ECG cable.	"Clinical testing was done to demonstrate the efficacy of the PhysioGlove compared to a standard 12-lead ECG cable. In all instances, the device functioned as intended."	This is a general statement and lacks specific performance metrics (e.g., sensitivity, specificity, accuracy, signal quality parameters, correlation coefficients).
Compliance with Performance Standards: Adherence to recognized medical device standards for ECG equipment.	"The device was tested according to the following performance standards: IEC 60601-2-25, EC53 and EC 11."	The document confirms testing against these standards, implying compliance, but does not provide results for specific tests within these standards.
Intended Use: Function as a 12-lead glove for configuring ECG electrodes.	"The 12 lead glove is designed to configure the ECG electrodes in a single unit for the purpose of conducting an electrocardiogram."	The device is described as functioning for its intended purpose.
Patient Chest Girth Range: Suitable for patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms).	"It is for use in patients with a chest girth of 33.5 - 46.5 inches (85 - 118 cms)."	This is an intended use specification, not a performance metric that was tested and confirmed in results provided here.
Safety and Effectiveness (Relative to Predicates): As safe and effective as identified predicate devices.	"The PhysioGlove is as safe and effective as the Tapuz ECG Electrodes Apron and the IneedMD 12-Lead Glove."	This is a conclusion of the equivalence assessment, not a specific performance metric.

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

Sample Size: Not specified in the provided text. The text only mentions "clinical testing."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set

Not specified.

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 involving AI assistance is not mentioned. The device is an ECG electrode glove, not an AI-powered diagnostic system. The comparative study was between the PhysioGlove and a standard 12-lead ECG cable.

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

Not applicable. The PhysioGlove is a hardware device (electrode glove), not an algorithm.

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

The text implies that the ground truth for the clinical comparison was established by the standard 12-lead ECG cable. The PhysioGlove's efficacy was compared to this standard, suggesting the standard itself served as the reference for "normal" and "intended" ECG recordings. Specific details on how "efficacy" was measured or adjudicated are not provided.

8. The sample size for the training set

Not applicable, as this is a hardware device for recording, not an AI model that requires a training set.

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

Not applicable.

Summary of Limitations in Provided Text:

The 510(k) summary provides a high-level overview for regulatory clearance. It confirms that the device was tested against relevant standards (IEC 60601-2-25, EC53, and EC 11) and underwent "clinical testing" demonstrating efficacy compared to a standard ECG cable. However, it lacks specific details regarding:

The design and methodology of the clinical study.
Quantitative results of the clinical testing (e.g., specific metrics for signal quality, diagnostic agreement, or concordance).
Sample sizes for any tests.
Details about how "ground truth" was rigorously established or evaluated beyond comparison to a "standard 12-lead ECG cable."

Summary

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K083677 Pl/2

510(k) SUMMARY

MAR 1 0 2009

COMMWELL LTD.'s PHYSIOGLOVE

A. General Information Submitter's Name: 1. Commwell Ltd. 2. Address: Rechov Yad Harutzim 4 Kfar Saba, Israel 44641 Telephone Number: 3. 9729-766-8094 4. Fax number: 9729-766-8099 5. Contact Person: Irving Levy 6. Date Prepared: December 11, 2008 Name of Device and Name/Address of Sponsor: B.

PhysioGlove

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

C. Device

Trade Name:
1. Common Name:
Classification Name: 3.
Product Code: 4.
1. Class:
ర్. CFR Reference:

D. Predicate devices

1. Name:	Tapuz Medical Technology's ECG Electrodes Apron
1. Date Cleared:	June 1, 2003 and Oct. 14, 1998 respectively

Name IneedMD 12-Lead Glove Date Cleared: Dec 22, 2004

\\DC - 080866/000001 - 2823607 v1

PHYSIOGLOVE 12-Lead Diagnostic ECG glove Electrocardiograph glove DRX II

21 CFR 870.2360

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E. Intended Use / Indications for Use

F. Technological Characteristics - Components and Safety Features

The PhysioGlove is a glove that incorporates a system of Ag/AgCI electrodes for use in recording ECGs. The glove terminates in a standard 15-pin mini D-type connector.

The PhysioGlove is intended to be used with the cleared PhysioGlove ES-1 software, for recording diagnostic 12-lead ECGs.

G. Performance Data

The device was tested according to the following performance standards: IEC 60601-2-25, EC53 and EC 11. In addition, clinical testing was done to demonstrate the efficacy of the PhysioGlove compared to a standard 12-lead ECG cable.

In all instances, the device functioned as intended,

H. Substantial Equivalence

The PhysioGlove is as safe and effective as the Tapuz ECG Electrodes Apron and the IneedMD 12-Lead Glove. The PhysioGlove has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the PhysioGlove and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the PhysioGlove is as safe and effective as the Tapuz ECG Electrodes Apron and the IncedMD 12-Lead Glove. Thus, the PhysioGlove is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

MAR I 0 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Commwell Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, NW Washington, DC 20004

Re: K083677

Trade/Device Name: PhysioGlove Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph electrode Regulatory Class: Class II Product Codes: DRX Dated: December 11, 2008 Received: December 11, 2008

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications 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 a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing 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 such 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. Jonathan S. Kahan

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); 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. This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

7 Bram D. Zuckerman, 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 (if known): K083677

Device Name: PhysioGlove

Indications for Use:

Prescription Use イ (Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Zuckerman

(Division Sign-Off) 3/14/09 Division of Cardiovascular Devices 510(k) Number K083677

Regulation Number and Section

§ 870.2360 Electrocardiograph electrode.

(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.