BLOOD PRESSURE METER, MODEL CH-4532 by CITIZEN SYSTEMS JAPAN CO., LTD.

Model CH-4532 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter from the FDA to Citizen Systems Japan Co., Ltd. for their Model CH-4532 Blood Pressure Meter. This document primarily focuses on regulatory approval and does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, training, and test set specifics for an AI/ML medical device.

The FDA 510(k) approval process for non-AI devices like this blood pressure meter typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than extensive clinical trials with detailed AI performance metrics.

Therefore, most of the specific questions you've asked cannot be answered directly from the provided text. I will indicate where information is missing or not applicable based on the document's content.

Acceptance Criteria and Device Performance (Not Available in Document)

The document does not detail specific performance acceptance criteria or report device performance data from a pivotal study. The FDA letter states the device is "substantially equivalent" to predicate devices, implying that its performance meets the regulatory bar set by those predicate devices, but the specific metrics are not elaborated here.

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria	Reported Device Performance
Not Available	Not Available	Not Available

Study Details (Not Available for AI/ML Device, General for this device)

Since this is a conventional blood pressure monitor and not an AI/ML device, many of the questions related to AI/ML specific study design (e.g., test set provenance, ground truth establishment, training set details) are not applicable.

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

Result from Document: Not applicable as this is a non-AI device. The FDA letter does not contain information on the clinical study's sample size or data provenance for demonstrating blood pressure measurement accuracy.
General Context: For blood pressure monitors, accuracy studies are typically conducted according to international standards (e.g., ISO 81060-2) which specify subject inclusion criteria, measurement protocols, and statistical analysis methods. These studies usually involve a specific number of subjects (e.g., at least 85 subjects for ISO 81060-2) covering a range of blood pressures.

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

Result from Document: Not applicable. For blood pressure monitors, "ground truth" for individual measurements is typically established by trained human observers using a reference sphygmomanometer (e.g., mercury sphygmomanometer with stethoscope auscultation, or another validated reference device), not by a panel of experts.
General Context: The "experts" would be the trained personnel performing the reference measurements, following a strict protocol.

4. Adjudication method for the test set:

Result from Document: Not applicable. Adjudication methods like 2+1 or 3+1 are common in AI/ML studies where human readers provide interpretations. For blood pressure device accuracy, the reference measurements are typically taken by multiple trained observers (sometimes blinded or dual-observer) to minimize individual bias, or by validated automated reference devices.
General Context: The "adjudication" would refer to how discrepancies between multiple reference measurements are handled, or how the reference measurement is compared to the device's measurement.

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:

Result from Document: Not applicable. This concept is specific to AI-assisted human interpretation tasks and does not apply to a standalone blood pressure measurement device.

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

Result from Document: The device, Model CH-4532 Blood Pressure Meter, is inherently a standalone device (an "algorithm only" in the sense that it performs automated measurements without human intervention in the core measurement process). The document states its indication for use is "for oscillometric measurement of systolic and diastolic blood pressure and pulse." The performance of this standalone device would have been evaluated to establish its substantial equivalence. The document, however, does not provide the performance results.

7. The type of ground truth used:

Result from Document: Not applicable.
General Context: For blood pressure monitors, the "ground truth" for blood pressure values is typically established by simultaneous or sequential measurements using a validated reference method, such as a mercury sphygmomanometer with a stethoscope (auscultation method) or another validated automated reference device. This is defined by recognized international standards (e.g., ISO 81060-2).

8. The sample size for the training set:

Result from Document: Not applicable. Blood pressure monitors like this typically do not have a "training set" in the AI/ML sense. Their algorithms (e.g., oscillometric algorithms) are developed based on physiological principles and validated against reference measurements, rather than "trained" on large datasets.

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

Result from Document: Not applicable. As mentioned above, there isn't a "training set" in the AI/ML context for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 1 0 2010

Citizen Systems Japan Co., Ltd. c/o Mr. Nathan A. Beaver Foley & Lardner LLP 3000 K Street NW, Suite 600 Washington, DC 20007

Re: K093931

Trade/Device Name: Model CH-4532 Blood Pressure Meter Regulatory Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II (Two) Product Code: DXN Dated: May 11, 2010 Received: May 11, 2010

Dear Mr. Beaver:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Nathan A. Beaver

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/ReportaProblem/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,

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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K093931

Image /page/2/Picture/1 description: The image contains the word "CITIZEN" in large, bold, black letters. Below "CITIZEN" is the phrase "Micro HumanTech" in a smaller font, also in black. To the right of the word "CITIZEN" is a handwritten fraction, which appears to be "1/1".

CITIZEN SYSTEMS JAPAN CO., LTD.

6-1-12, Tanashi-cho, Nishi-Tokyo-Shi, Tokyo 188-8511, Japan Tel : +81-424-68-4712 Fax : +81-424-68-4687

Date : November 30, 2009

Indications for Use

510(k) Number (if known):

Device Name: Model CH-4532 Blood Pressure Meter

Indications For Use: Model CH-4532 Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and is intended to be sold at a retail shop and to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use_____________X

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

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).