The Medic4All Telemedicine System Model VMS-01 is intended to collect and transmit physiological information, such as glucose levels, via standard telephone lines or the internet to local or remote computer systems for use by the patient or a healthcare professional.

Device Description

Medic4All's VMS-01 telemedicine system (VMS-01) is a wireless telephonic/internet-based physiologic monitoring system, designed for care of patients requiring periodic monitoring. It is designed for interactive, remote, physiological data measurement, transmission, processing, storage and display of data.

AI/ML Overview

Here's an analysis of the provided 510(k) submission for the Medic4All Telemedicine System VMS-01, focusing on acceptance criteria and study data:

Acceptance Criteria and Device Performance for Medic4All Telemedicine System VMS-01

Based on the provided K061502 510(k) summary, the device is a telemedicine system for collecting and transmitting physiological information. The performance data focuses on the functional integrity and reliability of the system rather than clinical efficacy or accuracy in diagnosing specific conditions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test/Evaluation Area	Stated Acceptance Criterion (Implied)	Reported Device Performance
System Functionality	EMC/Electrical Safety	Compliance with relevant standards	VMS-01 functioned as intended.
	Unit Testing	Individual components function correctly	VMS-01 functioned as intended.
	Integration Testing	Components work together seamlessly	VMS-01 functioned as intended.
	Data Integrity Testing	Data is accurately transmitted and stored	VMS-01 functioned as intended.
	Usability Testing	System is user-friendly and effective	VMS-01 functioned as intended.
	Environmental Testing	Device withstands specified environmental conditions	VMS-01 functioned as intended.
	Compatibility Testing	Device operates with intended external systems/networks	VMS-01 functioned as intended.
	Performance Testing	Meets defined operational parameters	VMS-01 functioned as intended.
	System Testing	Overall system meets specifications	VMS-01 functioned as intended.
	Load/Performance Testing	System performs under anticipated load and usage	VMS-01 functioned as intended.

It is important to note: The provided document does not specify quantifiable acceptance criteria (e.g., "data transmission success rate > 99%") or detailed performance metrics. The statement "In all instances, the VMS-01 functioned as intended" serves as the general reported performance against implied criteria for each test category.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The descriptions are general statements about various types of "verification and validation testing activities."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

The provided document does not mention using experts to establish ground truth for a test set. The validation activities described (EMC/Electrical Safety, unit testing, integration testing, etc.) are engineering and system validation tests, not clinical performance studies requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

As no expert adjudication for a clinical test set is mentioned, there is no adjudication method described.

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 MRMC comparative effectiveness study (human readers with/without AI assistance) was conducted or reported in this 510(k) submission. This is a telemedicine system for data transmission, not an AI-assisted diagnostic tool.

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

The "performance data" section describes standalone functional testing of the system components and the whole system (e.g., unit testing, integration testing, data integrity testing, load/performance testing). This is algorithm-only in the sense that the system's technical operation was evaluated independently. However, it's not a standalone clinical performance study in the way it might be for a diagnostic AI.

7. The Type of Ground Truth Used

For the functional and reliability testing described (EMC/Electrical Safety, unit, integration, data integrity, usability, environmental, compatibility, performance, system, load/performance testing), the "ground truth" would be established by:

Engineering specifications and design documents: Whether the system outputs match expected values, whether data is transmitted without corruption, whether modules integrate correctly.
Standards compliance: For EMC/Electrical Safety, testing against industry and regulatory standards.
User feedback/defined requirements: For usability testing, whether the system meets pre-defined usability criteria.

It is not clinical ground truth like expert consensus, pathology, or outcomes data, as this device primarily focuses on data collection and transmission functionality.

8. The Sample Size for the Training Set

This device is not an AI/machine learning model that requires a "training set" in the typical sense. It is a telemedicine system composed of hardware and software components. Therefore, no training set sample size is applicable or mentioned.

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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K061502
page 1 of 2

SEP 15 2006

5 510(K) SUMMARY

This summary of safety and effectiveness is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. § 807.92.

Submitter:

Medic4All (Israel) LTD.

10 Hamefalsim Street, POB 4222 Petach Tikva, Israel 49000 Phone number: +972-3-9226610 Fax number: +972-3-9226615

Contact Person:

Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW Washington DC 20004-1109

Phone: (202) 637-5794

Date Prepared: May 30, 2006

Name of the Device:

Medic4All Telemedicine System VMS-01

Predicate Devices:

The VMS-01 is substantially equivalent to:

. The Philips Medical Systems M3810A TeleMonitoring System with M3812B TeleStation (K023749).
The BL-Healthcare, Inc. Remote Care Management System (K051470). .

Intended Use / Indications for Use

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K041502
page 2 of 2

Technological Characteristics

Performance Data

Verification and validation testing activities were conducted to establish the performance and reliability characteristics of the telemedicine system. Testing involved EMC/Electrical Safety; unit testing; integration testing; data integrity testing; usability testing; environmental testing; compatibility testing; performance testing, system testing, load/performance testing for the whole telemedicine system. In all instances, the VMS-01 functioned as intended.

Substantial Equivalence

The VMS-01 system is substantially equivalent to the Philips Medical Systems M3810A TeleMonitoring System with M3812B TeleStation (K023749) and the BL-Healthcare, Inc. Remote Care Management System (K051470). The VMS-01 has the same intended uses and substantially similar indications, technological characteristics, and principles of operation as these predicate devices. The minor differences in indications for use and technology between the VMS-01 and the predicate devices raise no new issues of safety or effectiveness, as demonstrated by performance test data.

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Public Health Service

Image /page/2/Picture/11 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 5 2006

Medic4All (Israel) LTD. c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, NW Washington DC 20004-1109

Re: K061502

Trade Name: Telemedicine System Model VMS-01 Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulatory Class: Class II (two) Product Code: DRG Dated: August 30, 2006 Received: August 30, 2006

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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Blymmmer for

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

Enclosure

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4 INDICATIONS FOR USE STATEMENT

14041502 510(k) Number (if known):

Device Name: Telemedicine System Model VMS-01

Indications for Use:

Prescription Use

AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of

Ondell

(Division Sian-Off) Division of Cardiovascular Devices 510(k) Number KO6 502

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).