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The device is a digital monitor intended for use in measuring blood pressure and pulse rate in adult patient population with wrist circumference ranging from 5 1/4 inches to 8 1/2 inches (13.5 cm to 21.5 cm). The device detects the appearance of irregular heartbeats during measurement and gives a warning signal with readings.

The device is an automatic non-invasive blood pressure system. The device is battery powered by 2 "AAA" batteries, there is no connection to external power. The device inflates a wrist cuff with an integral pump, then deflates the cuff via an electronically controllable valve. During inflation the cuff pressure is monitored and pulse waveform data is extracted. The extracted pulse waveform data is then analyzed by software which determines pulse rate, as well as systolic and diastolic pressure. The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate. The device has a memory function that automatically stores up to 60 of the latest measurements. It can also display an average of the last three values. The device also detects the appearance of irregular heartbeats during measurement.

Here's a breakdown of the acceptance criteria and the study details for the Omron HEM-6131, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document primarily highlights compliance with standards and equivalence to the predicate device, rather than providing specific test results against numerical performance targets for accuracy within the summary. However, it explicitly states "Accuracy or pressure indicator: +/-3 mmHg or 2% of reading" and "Accuracy Pulse Rate: +/-5%" as specifications in the device comparison table, implying these are the acceptance criteria.

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

• Sample Size for Test Set: 85 patients (36 males and 49 females).
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. However, clinical testing for medical devices is typically prospective.

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

• Number of Experts: Not explicitly stated, however, the "Standard auscultation method" was used as the reference blood pressure (BP) measurement. This implies that trained medical professionals (likely physicians or nurses) performed the auscultation, but the specific number and qualifications are not detailed.

4. Adjudication method for the test set

• Adjudication Method: Not explicitly stated. The "Standard auscultation method" was used as the reference, suggesting a direct comparison, rather than a multi-expert adjudication process.

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

• MRMC Study: No, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This device is a standalone non-invasive blood pressure monitor, not an AI-assisted diagnostic tool for interpretation by humans.

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

• Standalone Performance: Yes, the clinical accuracy study directly evaluated the device's measurements (algorithm only) against the standard auscultation method without human intervention in the device's measurement process.

7. The type of ground truth used

• Ground Truth Type: Expert consensus using the "Standard auscultation method" for blood pressure measurement.

8. The sample size for the training set

• Training Set Sample Size: Not provided in the summary. The document mentions that "The algorithm used to determine pulse rate, systolic and diastolic pressure is identical to the predicate," which suggests the algorithm was already developed and potentially trained on other data, but this information is not included for the HEM-6131 specifically.

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

• Training Set Ground Truth: Not provided in the summary. Given that the algorithm is "identical to the predicate," the ground truth establishment for its training would have occurred during the development of the predicate device, and those details are not within this submission.

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