The Aerotel MPM SYSTEM is indicated when patients use with home patient monitoring devices (blood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) and wish to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.

Device Description

The system comprises a modem-like device that connects to various cleared measurement devices and a central station program that keeps the records of the patients, and makes the reports available ... the internet.

AI/ML Overview

The Aerotel Medical Systems (1998) Ltd. MPM System functions as a device simplifying the transmission of patient health data from home monitoring devices to a central station for review by physicians and patients.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., sensitivity, specificity, accuracy, error rates for data transmission). Instead, the acceptance is based on the system's ability to satisfactorily pass internal tests and its equivalence to predicate devices.

Acceptance Criterion	Reported Device Performance	Study that Proves Performance
Functional Equivalence	The system has been tested with all compatible measuring units and has satisfactorily passed the tests. The software has been extensively validated.	Internal non-clinical tests
Safety and Efficacy Equivalence	The MPM system is equivalent in safety and efficacy to the legally-marketed predicate devices.	Conclusion based on the absence of new technology and comparison to predicate devices; no specific study details provided beyond this assertion.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not mentioned. The document states, "The system has been tested with all of the compatible measuring units," but doesn't specify how many tests were run, the number of data points, or the number of patients/users involved in these "non-clinical tests."
Data Provenance: The tests are described as "Non-clinical tests," implying laboratory or internal testing rather than real-world patient data. There is no information regarding the country of origin of this data, but given the company's location in Israel and the regulatory submission to the FDA in the US, it's likely conducted internally without external patient data. The study is retrospective in the sense that completed tests were reviewed for the submission.

3. Number of Experts and Qualifications for Ground Truth

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned. The "satisfactorily passed the tests" statement implies internal review by the company's technical personnel, but no specifics are provided.

4. Adjudication Method for Test Set

Adjudication Method: Not mentioned. The nature of the non-clinical tests suggests internal validation against pre-defined functional specifications rather than an external human adjudication process.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical tests are not necessary because the device does not use new technology." The device's primary function is data transmission, not diagnostic interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device's intended use according to the submission.

6. Standalone (Algorithm Only) Performance

Standalone Performance: Yes, the described "Non-clinical tests" and "software... extensively validated" can be considered a form of standalone performance evaluation for the system's data transmission and processing functions. The device is intended to operate automatically in transmitting data. However, specific metrics (e.g., data transmission error rates, uptime) are not provided, only the general statement that it "satisfactorily passed the tests."

7. Type of Ground Truth Used

Type of Ground Truth: The ground truth for the non-clinical tests would likely be functional specifications and expected data output. For example, if a blood pressure reading of "120/80" was input from a compatible device, the ground truth would be that the system should accurately transmit and present "120/80" at the central station without corruption or error. There would be no "expert consensus," "pathology," or "outcomes data" in the traditional medical sense, as this device's role is data conduit.

8. Sample Size for Training Set

Sample Size for Training Set: Not applicable. The MPM System, as described, is a data transmission system and not an AI/machine learning device that 'learns' from a training set of data to make predictions or classifications. Therefore, the concept of a "training set" in the context of AI development is not relevant here.

9. How Ground Truth for Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for an AI/machine learning model.

Summary

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OCT 6 - 2004

Image /page/0/Picture/3 description: The image shows the alphanumeric string "K041854" in a bold, sans-serif font. Below this string, there is another string "P 1/2" written in a smaller, less defined font. The overall impression is that of a label or identifier, possibly from a document or inventory system.

Aerotel Medical Systems (1998) Ltd. 510(k) Submission BP-Tel Trans-Telephonic Blood Pressure Measurement System

510(k) Summary

(1) Submitter Information

Name: Aerotel Medical Systems (1998) Ltd.

Address:

5 Hazoref Street 58858 Holon Israel

Telephone Number: 972-3-559-6111

Contact Person: Dr. George Myers (Official Correspondent) Medsys Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604 Telephone 201-727-1703 Fax 201-727-1708

Date Prepared: June 3, 2004

(2) Name of Device

Trade Name: MPM System Common Name: Device for transmitting measurement parameters from the home and receiving them at a central station with Internet Access. Classification name: Telephone electrocardiograph transmitter and receiver.

(3) Equivalent legally-marketed devices.

1. Cybernet Medical Medstar, K020534
1. Aerotel BPTEL/MPM, K983717
1. Aerotel TeleCliniQ, K021447
1. Aerotel MPMP-Net, K030825

(4) Description

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2-1 2-

The system comprises a modem-like device that connects to various cleared measurement devices and a ntral station program that keeps the records of the patients, and makes the reports available ... the internet.

(5) Intended Use

The Aerotel MPM SYSTEM is intended to be used with home patient monitoring devices (b)ood pressure, digital scale, blood glucose level, respiratory peak flow, pulse oximetry) to send the measured data to a central station via modem by telephone, where reports can be generated for the physician and reports can be received over the Internet by physicians and patients.

(6) Performance Data

(a) Non-clinical tests

The system has been tested with all of the compatible measuring units and has satisfactorily passed the tests. The software has been extensively validated.

(b) Clinical tests

Clinical tests are not necessary because the device does not use new technology/

The MPM system is equivalent in safety and efficacy to the legally-marketed predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare. The caduceus is composed of three parallel lines that curve and flow together.

OCT 6 - 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aerotel Medical Systems, Ltd. c/o George H. Myers, Sc.D. Medsys, Inc. 377 Route 17 S Hasbrouck Heights, NJ 07604

Re: K041854

Trade Name: MPM System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: II (two) Product Code: DXN Dated: July 7, 2004 Received: July 8, 2004

Dear Dr. Myers:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally manatis and the Medical Device American by to de Ford. Four conninered phor to they 2011-03-12) in accordance with the provisions of the Federal Food, DNIg, de vices that have been require approval of a premarket approval application (PMA). and Cosmetic 710 (710) that as not some of in the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls pro reserving 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 rr your device to such additional controls. Existing major regulations affecting your device can may be subject to back adders and 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 - George H. Myers, Sc.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA S Issualice of a subside on the requirements of the Act
that FDA has made a determination that your device complies with of acception. Your must that FDA has made a dolorimiation administered by other Federal agencies. You must or any Federal statutes and regulations daminding, but not limited to: registration and listing (21) comply with an the Act 3 requirements, merceans, and manufacturing practice requirements as set CFK Part 807); labeling (21 CFR Part 800); good manat 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 81 CFR 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (overlees) (over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in 10 I his letter will anow you to ocgin marketing your and equivalence of your device to a legally premarket notification: "The FDA inding of bactualized on 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 If you desire specific advice for your ac 11 594-4648. Also, please note the regulation entitled, and Colliact the Office of Complanou at (501) 37 - 7 - 7 - 7 - 7 807.97). You may obtain " Misoranding of Icierchee to premanter is thirds. In the Act from the Division of Small
other general information on your responsibilities under the Act from the 1990 Call o other general information on your respense Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Blimmimo for

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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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Indications for Use Form

Device Name: MPM System

Indications for Usc:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
Use

(Per 21 CFR 810.109)

Over-the-Counter

(Optional Format 1-2-96)

Blumuma

lon Slanof Cardlovascular Devices 510fk] Number

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).