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The Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C is a device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive oscillometric technique in which an inflatable cuff is wrapped around the wrist.

The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected.

The device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C is designed to measure systolic and diastolic blood pressure, pulse rate of an individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. Our method to define systolic and diastolic pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals to define the systolic and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device has an Irregular Heartbeat Detection (IHD) function. It detects the appearance of irregular heartbeat during measurement and the irregular heart beat symbol "is displayed on the LCD screen if any irreqular heart beat signal has been detected. In addition, the device can be used in connection with your personal computer (PC) running the Microlife Blood Pressure Analyzer (BPA) software. The memory data can be transferred to the PC by connecting the monitor with the PC via USB cable.

The device being reviewed is the Microlife Wrist Watch Blood Pressure Monitor, Model BP3BS1-3C.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for the clinical performance testing of the modified device.
• Data Provenance: The document states that the modified device (BP3BS1-3C) did not undergo new clinical testing because it is "identical" in technical aspects and measurement algorithm to the predicate device (BP3MK1-3). Therefore, the clinical performance data would be derived from the studies supporting the predicate device, but the specifics of those studies (e.g., country of origin, retrospective/prospective nature) are not provided in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. No new clinical study was performed for the modified device to establish ground truth for blood pressure measurements. Clinical testing for blood pressure monitors typically involves comparison to a reference standard (e.g., sphygmomanometer measurements by trained observers), not expert consensus in the same way an imaging AI might.

4. Adjudication Method for the Test Set

• Not Applicable. As no new clinical test set was used for the modified device, there was no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers. There is no mention of an MRMC study.

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

• Yes, effectively. The performance of the device's blood pressure measurement algorithm is assessed against a standard (ANSI/AAMI SP10: 2008), which represents standalone performance. The document explicitly states that "the measurement algorithm and its program codes of BP3BS1-3C remain unchanged," implying its standalone performance maintains equivalence to the predicate device.

7. The Type of Ground Truth Used

• Reference Standard Measurements (for predicate device): For blood pressure monitors conforming to standards like ANSI/AAMI SP10, the ground truth for blood pressure measurements is established by trained observers using a reference standard method (e.g., auscultatory method with a mercury sphygmomanometer). While not detailed for this specific submission, it's inferred from the standard adherence.

8. The Sample Size for the Training Set

• Not Applicable / Not provided. Blood pressure monitors using the oscillometric method are based on established physiological principles and algorithms, rather than training a machine learning model on a "training set" in the conventional sense of AI. The algorithm for the device "remains unchanged" from its predicate, which indicates it's a fixed, established algorithm.

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

• Not Applicable / Not provided. As mentioned above, this isn't a machine learning device that requires a training set and corresponding ground truth in the same way an AI diagnostic algorithm would. The algorithm's development (for the predicate device) would have been based on physiological models and empirical data, but not a "training set" in the modern AI context.

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