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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 5.3 inches to 8.5 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 Wrist Blood Pressure Monitor (BPM) Model BP6100 ("BP6100") is an automatic, non-invasive, wrist-worn blood pressure measurement system for over-the-counter (OTC) home use. During measurements, an electric pump within the main unit slowly inflates the wrist cuff, generating cuff pressure which is monitored and from which pulse waveform data is extracted. This waveform data is analyzed by software algorithms within the microprocessor to determine pulse rate, systolic pressure, and diastolic pressure. The systolic and diastolic pressures are determined via the oscillometric cuff method. The cuff pressure range is 0 to 299mmHg and the pulse rate range is 40 to 180 beats/min.

The BP6100 is intended for use in the adult patient population, in wrist circumferences ranging between 5.3 - 8.5 inches (13.5 - 21.5 cm). During measurement, the device also detects the appearance of irregular heartbeat rhythms. BP6100 further includes administrative functions for automatic storage of the 60 most recent readings taken by the device. The device also provides an "average" function, which can calculate an average reading based on the latest two (2) or three (3) readings, when taken within a 10-minute span.

The operations of BP6100 are primarily through use of buttons. Functions and other features that are controlled by the end user include applying the wrist cuff to the wrist, powering on/off the system, starting or stopping measurements, and installing and changing batteries as needed. It has no potential connection to external power. There are no additional parts or accessories to the BP6100. The BP6100 does not connect to any other devices.

The provided document is a 510(k) summary for the Omron Healthcare, Inc. Wrist Blood Pressure Monitor Model BP6100. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to a predicate device (Omron Healthcare, Inc. HEM-6131).

Based on the provided information, here's a description of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria for the Omron BP6100 are primarily aligned with the standards used for the predicate device, K131742 (HEM-6131), and the ANSI/AAMI/ISO 81060-2:2013 standard.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Sample Size: The document does not explicitly state the numerical sample size for the clinical investigation. It mentions that the study was conducted "in accordance with guideline per ANSI/AAMI/ISO 81060-2:2013 Non-invasive sphygmomanometers — Part 2: Clinical investigation of automated measurement type." This standard typically specifies minimum sample sizes (e.g., 85 subjects for validation in the general population). While the exact number isn't present, compliance with this standard implies a sufficient sample size was used.
• Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, but clinical investigations for device validation like this are almost universally prospective studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• The ground truth for blood pressure measurement in the clinical investigation was established using an "auscultation method using a calibrated sphygmomanometer by trained medical staff."
• The document does not specify the exact number of experts (medical staff) or their specific qualifications (e.g., years of experience, specific medical degree beyond "trained medical staff"). However, for such studies, it implies that the personnel performing the auscultation measurements are qualified and trained according to standard medical practices for blood pressure measurement.

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

• The document does not describe a specific adjudication method like "2+1" or "3+1." The ground truth was established by "trained medical staff" using the auscultation method. In the context of a clinical investigation for a blood pressure monitor validating against an auscultatory reference, the comparison is typically direct, and an adjudication process beyond the core measurement methodology itself is not usually required or described in a 510(k) summary for this type of device.

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

• No, an MRMC comparative effectiveness study was not done. This device is a standalone blood pressure monitor, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images or data with and without AI assistance. The study was a clinical investigation validating the accuracy of the device against a reference method (auscultation), not evaluating human performance.

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

• Yes, a standalone performance evaluation was indeed done. The clinical investigation directly validated the accuracy of the BP6100 device's oscillometric measurements ("algorithm only") against the auscultation method. This represents the device's performance without "human-in-the-loop" assistance in the measurement itself, although a human operates the device. The non-clinical bench testing also evaluated the device's standalone performance.

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

• The primary ground truth for the clinical investigation was expert-performed auscultation using a calibrated sphygmomanometer. This is considered the reference standard for non-invasive blood pressure measurement.

8. The sample size for the training set

• The document describes a clinical investigation and bench testing for device validation. It does not mention a "training set" or "test set" in the context of machine learning (AI/ML models). This is a traditional medical device, not an AI device. Therefore, there is no AI model training set.

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

• As this is not an AI/ML device, there was no "training set" in the AI sense, and therefore no ground truth established for such a set. The studies described are for validation of the device's inherent accuracy and performance.

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