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The Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X 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 via cable with the PC.

Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X 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 capacitor 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 Irregular Heartbeat Detection (IHD) function. It detects the appearance of irreqular heartbeat during measurement and the irreqular heart beat symbol " is displayed on the LCD screen if any irregular 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X.

Based on the provided document, the device did not undergo specific clinical testing for its overall accuracy and performance for this particular submission (K141083). Instead, the submission relies on the "substantial equivalence" principle to predicate devices. Therefore, direct acceptance criteria and study data for this specific model as if it were a novel device are not present in the given text.

The document claims that the device's measurement algorithm and program codes from a predicate device (BP3BS1-3C) remain unchanged, and therefore its performance in terms of blood pressure measurement would be identical. This means the clinical performance data would refer to those predicate devices, not the BP3NU1-4X directly.

However, I can extract information relevant to the type of testing and standards that would typically apply to such a device, and how the manufacturer justifies not conducting new clinical trials for this specific model.

Acceptance Criteria and Study for Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X

Important Note: The provided document states that no new clinical testing was necessary for the Microlife Wrist Watch Blood Pressure Monitor, Model BP3NU1-4X because its fundamental scientific technology, measurement algorithm, and program codes are identical to a predicate device (Model BP3BS1-3C). Therefore, the "reported device performance" in the table below reflects the performance expected based on the predicate device, or general expectations for such devices, rather than new, specific performance data for Model BP3NU1-4X itself.

1. Table of Acceptance Criteria and the Reported Device Performance

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

• Clinical Performance Test Set: No new clinical test set was used for the BP3NU1-4X device itself, specifically for blood pressure measurement accuracy. The justification for substantial equivalence is based on the performance of a predicate device (BP3BS1-3C). The document does not specify the sample size or data provenance for the original clinical studies performed on the predicate device.
• Non-Clinical Testing: The non-clinical tests (reliability, EMC) were conducted on the BP3NU1-4X device. The sample sizes for these engineering tests are not specified but are typically sufficient to demonstrate compliance with the respective standards.

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

• Not applicable for the BP3NU1-4X directly, as new clinical testing was not performed. For the predicate device, clinical validation (e.g., against ANSI/AAMI SP10) would typically involve qualified clinicians taking reference measurements (e.g., auscultatory readings by trained observers) to establish ground truth. The document does not provide details on these experts for the predicate testing.

4. Adjudication method for the test set

• Not applicable as new clinical testing was not performed for the BP3NU1-4X. In a typical clinical validation for a blood pressure monitor, multiple trained observers often take reference readings, and their agreement (or specific adjudication rules) would be used to establish the validated ground truth.

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, not an AI-assisted diagnostic imaging device requiring human reader intervention.

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

• Yes, implicitly. The blood pressure measurement algorithm operates autonomously without human intervention during measurement. The justification for substantial equivalence relies on the standalone performance of this algorithm, which remains "unchanged" from the predicate device. The accuracy testing required by standards like ANSI/AAMI SP10 is a standalone performance evaluation of the device's measurement capabilities against a reference standard.

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

• For the blood pressure accuracy (referencing the predicate device's clinical validation), the ground truth would typically be established by simultaneous auscultatory measurements performed by trained human observers using a mercury sphygmomanometer or another validated reference device, following standardized protocols (e.g., specified by ANSI/AAMI SP10).
• For non-clinical tests, ground truth is the specified engineering requirement or standard for the test (e.g., specific voltage levels for EMC, impact force for drop tests).

8. The sample size for the training set

• Not applicable. This device is likely using a fixed algorithm based on established oscillometric principles, not a machine learning model that requires a distinct "training set" in the conventional sense. The "training" or development of the algorithm would have occurred during the initial design of the oscillometric method, likely incorporating physiological models and experimental data, but this is not disclosed as a separate dataset in this submission.

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

• Not applicable for the same reasons as (8). Any data used for the development of the oscillometric algorithm would have been associated with reference measurements (e.g., auscultatory) to optimize the algorithm's accuracy, but this is part of the fundamental technology development, not a separate "training set" for an AI model in this context.

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