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The Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B 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 for a circumference range from 13.5 to 21.5cm. 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 a smart phone running the APP. The memory data can be transferred to the smart phone via Bluetooth.

Microlife Wrist Watch Blood Pressure Monitor, Model BP3GK1-4B is designed to measure systolic and diastolic blood pressure and 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 a semiconductor sensor rather than a stethoscope and mercury manometer. The sensor converts tiny alterations in cuff pressure to electrical signals, by analyzing those signals and diastolic blood pressure and calculating pulse rate, which is a well - known technique in the market called the "oscillometric method".

The device detects the appearance of irregular heartbeat during measurement. In addition, the device can be used in connection with smart mobile devices running the APP and via Bluetooth.

The provided text does not contain information about "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of performance metrics like accuracy for the subject device (Microlife Wrist Watch Blood Pressure Monitor Model BP3GK1-4B).

Instead, it states that:

• The subject device is considered "identical" to a predicate device (BP3NN1-3E, K151330) from a clinical validation standpoint for blood pressure measurement.
• Therefore, "no repeated clinical testing was required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."

To answer the request fully, the clinical validation study for the predicate device (BP3NN1-3E, K151330) would need to be reviewed. The provided document points to "AAMI / ANSI/IEC81060-2" as the standard for clinical validation, but it does not detail the specific results for the predicate or subject device against those criteria within this submission.

Therefore, I cannot populate the table or answer all the sub-questions directly from the provided text for the subject device.

However, I can extract the general accuracy criteria typically expected for such devices, as mentioned in the comparison table for Pressure and Pulse Rate Accuracy, which is shared between the subject device and Predicate device No.1.

Here's what can be extracted based on the provided text's limited information regarding performance for the subject device, and an acknowledgement of assumptions made based on shared specifications with the predicate device:

Acceptance Criteria and Device Performance (Based on shared specifications with Predicate Device No.1, as a clinical study was not performed on the subject device due to substantial equivalence claim):

There is no specific clinical study detailed for the subject device (BP3GK1-4B) in this document to prove it meets acceptance criteria, as the manufacturer claims substantial equivalence to a predicate device (BP3NN1-3E, K151330) and leverages its clinical validation. The acceptance criteria listed below are common performance specifications for such devices, and for this submission, the subject device is considered to meet these based on its substantial equivalence to the predicate device which presumably met these in its own 510(k) submission (K151330).

1. Table of Acceptance Criteria and the Reported Device Performance (for clinical accuracy)

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

• Not provided for the subject device (BP3GK1-4B). The document explicitly states: "There was no repeated clinical testing required for blood pressure measurement to support BP3GK1-4B as the subject device can leverage the clinical validation of BP3NN1-3E that was proven in K151330."
• To obtain this information, the 510(k) submission K151330 for the predicate device BP3NN1-3E would need to be reviewed.

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

• Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Blood pressure monitor validation studies typically involve comparison against reference measurements taken by trained operators.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not provided for the subject device. This information would be within the clinical validation study of the predicate device (K151330), if detailed. Standards like AAMI/ANSI/IEC 81060-2 specify requirements for comparing automated blood pressure measurements against auscultatory measurements by human observers.

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:

• Not applicable. This device is an automated blood pressure monitor for direct blood pressure and pulse rate measurement, not an AI-assisted diagnostic tool for human readers. It does not involve "human readers" in its primary function for diagnosis, but rather provides direct readings to the user.

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

• Yes, implicitly. The device operates standalone to provide blood pressure readings. The claim of substantial equivalence for blood pressure measurement performance means the device's algorithm performs its intended function without human intervention in the measurement process itself. The clinical validation referenced by the predicate (K151330) against the AAMI / ANSI/IEC81060-2 standard would have assessed this standalone performance against reference measurements.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Presumed to be reference blood pressure measurements. For blood pressure monitors, the ground truth is typically established using a reference method, such as auscultatory measurement by trained observers using a mercury sphygmomanometer or another validated reference device, following international standards like AAMI/ANSI/IEC 81060-2.

8. The sample size for the training set:

• Not applicable / Not provided. For a hardware device with an embedded algorithm like this, there isn't typically a "training set" in the machine learning sense for the end-user product. The algorithm development may have involved internal data for calibration and optimization, but this is distinct from a clinical validation "test set." The document does not provide details on algorithm development data.

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

• Not applicable / Not provided. (See point 8).

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