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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 arm circumference ranging from 9 inches to 17 inches (22 cm - 42 cm). The device detects the appearance of irreqular heartbeats during measurement and gives a warning signal with readings. This blood pressure monitor compares average blood pressure results to pre-established AHA (American Heart Association) hypertension quideline of 135/85 mmHq. The Omron 780N3 model is not intended to be a diagnostic device. Contact your physician if hypertensive values are indicated.

Automatic Blood Pressure Monitor Model: HEM 780N3

This document is a 510(k) clearance letter for the OMRON Automatic Blood Pressure Monitor Model: HEM-780N3. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain the acceptance criteria, study details, or performance data that would typically be found in a clinical study report or a more detailed submission document.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is what can be inferred or stated based on the provided text, and what information is missing:

1. Table of acceptance criteria and reported device performance:

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

• Sample size: Not provided.
• Data provenance: Not provided (e.g., country of origin, retrospective/prospective). This document only covers the FDA's decision on substantial equivalence, not the details of the studies conducted by the manufacturer.

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

• Number of experts: Not provided.
• Qualifications of experts: Not provided.

4. Adjudication method for the test set:

• Not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human "readers" interpreting output. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant for this type of device.

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

• Yes, implicitly. As an automatic blood pressure monitor, its core function is to produce a blood pressure reading without human interpretation of raw data. The performance study (which is not detailed here) would have assessed the device's accuracy in a standalone capacity.

7. The type of ground truth used:

• Not explicitly stated, but highly likely to be a reference standard blood pressure measurement. For blood pressure monitors, the ground truth is typically established by simultaneous measurement using a highly accurate, often invasive or a standardized auscultatory method (e.g., Korotkoff sounds by trained observers with a mercury sphygmomanometer), following protocols like ISO 81060-2 or AAMI standards.

8. The sample size for the training set:

• Not applicable/Not provided. As an automatic blood pressure monitor, the term "training set" is usually associated with machine learning devices. While there is likely calibration data used during development, it is not referred to as a "training set" in the context of traditional medical device validation. If the device uses any form of adaptive algorithm, details of its development data would be in a separate study report.

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

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

Summary of what the document does provide:

• Device Name: OMRON AUTOMATIC BLOOD PRESSURE MONITOR MODEL: HEM-780N3
• Intended Use: Measuring blood pressure and pulse rate in adult patients with arm circumference 9-17 inches (22-42 cm).
• Additional features: Detects irregular heartbeats and provides a warning signal. Compares average readings to AHA hypertension guidelines (135/85 mmHg).
• Limitation: Not intended to be a diagnostic device.
• Regulatory Class: Class II (two)
• Product Code: DXN
• Predicate Device: Substantially equivalent to devices marketed prior to May 28, 1976.

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