MEDITECH MODEL ABPM-04 by MEDITECH KFT.

The Meditech ABPM-04 device automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

Device Description

AI/ML Overview

The provided text is a 510(k) premarket notification summary from the FDA for a device called "Meditech ABPM-04 Ambulatory Blood Pressure Monitor." This document confirms the device's substantial equivalence to a legally marketed predicate device, but it does not contain specific acceptance criteria or a study that directly proves the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document states:

"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..."

This means the FDA has determined that the Meditech ABPM-04 is as safe and effective as a similar device already on the market. However, the details of the studies conducted to demonstrate this substantial equivalence, including acceptance criteria and performance data, are typically found in a separate FDA review memo or the manufacturer's 510(k) submission, not in this clearance letter itself.

Therefore, I cannot provide the requested information based solely on the provided text.

Here's why each point cannot be answered:

A table of acceptance criteria and the reported device performance: This document does not specify any quantitative acceptance criteria or provide a table of performance metrics.
Sample size used for the test set and the data provenance: Not mentioned in this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
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: This device is an ambulatory blood pressure monitor, not an AI-assisted diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device measures blood pressure using an oscillometric method, which is an algorithm, but the document does not detail a standalone performance study.
The type of ground truth used: Not explicitly stated, though for blood pressure monitors, ground truth typically involves a reference method like invasive arterial pressure measurement or a highly accurate clinical standard.
The sample size for the training set: Not mentioned.
How the ground truth for the training set was established: Not mentioned.

To obtain this information, one would need to access the full 510(k) submission (if it's publicly available) or the FDA's internal review memorandum for K051149.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is surrounded by a circular border containing the text "U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" in capital letters.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2005

MEDITECH KFT. c/o Mr. Benny Arazy Arazy Group Mizpe Aviv, Industrial Park 13 M. P. Misgav 20187 ISRAEL

Re: K051149

Trade Name: Meditech ABPM-04 Ambulatory Blood Pressure Monitor Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (two) Product Code: DXN Dated: May 4, 2005 Received: May 4, 2005

Dear Mr. Arazy:

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. Benny Arazy

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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Blimimton 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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8.3 Indications for Use

510(k) Number (if known): Not applicable

Device Name: Noninvasive Blood Pressure Measurement System, Meditech ABPM-04

Indications for Use:

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Meditech Kit, - Orvosi F 1191 Budapest, Ulloi ut . Adoszára: 10397880-

Prescription Use

・・・

AND / OR

Over-the-Counter Use

(21 CFR 801 Subpart C)

(Part 21 CFR 801 Subpart D)

Srilanka

General Manager (Name & Signature)

4-12-05
Date

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Brammer

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on sign-om Islon of Cardiovascular Devic 510(k) Number 15/140

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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).