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The device is intended for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm.

The Wrist Blood Pressure Monitor is a reusable, active, non-sterile, non-invasive and non-implantable device for use in measuring blood pressure in adult patient population with wrist circumference ranging from 13.0 cm to 21.0 cm. It is a home-use device prohibited from use in MRI (magnetic resonance imaging) environment. This device has the systolic and diastolic display features. The device is of the watch type and powered by a rechargeable lithium-polymer battery. An AC adapter is used for charging the device, but the device cannot be operated while charging. The device wrist cuff inflates using an integral pump, and deflates via an electric valve. During inflation, the wrist cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines systolic and diastolic blood pressure. The systolic and diastolic blood pressures are measured using the oscillometric method. The cuff can measure pressure range from 0 to 300mmHg. Product includes device (preinstalled with a strap and large-sized cuff: 16.6-21.0cm), strap with a medium-sized cuff: 13.0-16.5cm, wrist measuring tape, charging base (with the power cable). The product functional configurations of OHMS11 and OHMS12 are completely identical, and the difference between the two is reflected in the color (OHMS11 is the dark gray color, OHMS12 is the champagne color).

The provided text describes the acceptance criteria and a study for a Wrist Blood Pressure Monitor (OHMS11, OHMS12).

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: 85 patients (49 males and 36 females)
• Data Provenance: Clinical study, conducted prospectively as patients "volunteered to take part in the subjects completed the clinical study." The country of origin is not explicitly stated in the provided text.

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

The document does not specify the number of experts used or their qualifications for establishing the ground truth. It mentions that "manual Mercury Sphygmomanometer was used as a reference device" and that the study followed ISO 81060-2. This standard generally requires trained observers for the reference measurements, but specific expert details are absent.

4. Adjudication method for the test set

The document states, "Same arm sequential method was adopted during the clinical testing." This indicates a specific measurement protocol where both the test device and the reference device take measurements sequentially on the same arm. There is no mention of an adjudication method involving experts for discrepancies in ground truth, as the ground truth is established by the reference device 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool requiring human reader evaluation.

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

Yes, a standalone performance study was done. The clinical testing evaluates the device's accuracy (algorithm only) against a reference standard (manual mercury sphygmomanometer) without direct human intervention in interpreting the device's output. The device itself performs the measurement and provides the blood pressure readings.

7. The type of ground truth used

The ground truth used was comparison to a reference device, specifically a "manual Mercury Sphygmomanometer," following the methodology of ISO 81060-2. This is a clinical standard for validating automated blood pressure monitors.

8. The sample size for the training set

The document does not provide information regarding a training set sample size. This type of submission (510(k) for a hardware device with embedded algorithms) typically focuses on validation data rather than detailed training information for AI/ML models.

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

Since no training set information is provided, there is no information on how its ground truth would have been established. It is assumed the device relies on established oscillometric principles rather than a deep learning model requiring a large labeled training set.

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