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The GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, is a non-invasive blood pressure measurement device that is used for measuring systolic and diastolic blood pressure and pulse rate using the oscillometric method for adults at home.

The device has an irregular heartbeat (IHB) indicator. The appearance of an irregular heartbeat during measurement, and displays an IHB symbol on the LCD with the reading once the irregular heartbeat is detected.

The GMC Wrist Automatic Blood Pressure Monitor, Model BO705, measures systolic and diastolic blood pressure and pulse rate of an adult individual. The method used to define blood pressure is similar to the auscultatory method but uses an electronic pressure sensor rather than a stethoscope and mercury manometer. The device utilizes the oscillometric method whereby the electronic pressure sensor converts variation in cuff pressure to electrical signals. The electrical signals are analyzed and used to define the systolic and diastolic measurements and determine the pulse rate. An irregular heart beat (IHB) indicator is displayed when there is more than a 25% deviation from the averaged pulse rate measurements.

The provided text describes the GMC Wrist Automatic Blood Pressure Monitor, Model BQ705, and includes information about its performance testing and clinical investigation.

Here's a breakdown of the requested information:

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

The document explicitly states that the device complies with several standards, including IEC 80601-2-30 and ISO 81060-2, which define performance criteria for non-invasive blood pressure monitors. The "Accuracy" row in the comparison table indicates the performance:

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: 85 patients (38 males and 47 females) were invited for the clinical study.
• Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, based on the phrasing "were invited for the study" and the mention of a "Clinical Investigation Report," it strongly implies a prospective clinical study.

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 was established using the "Standard auscultation method." While it doesn't specify the number or qualifications of the individuals performing the auscultation, for clinical studies involving blood pressure, the auscultatory method typically involves trained medical professionals. The mention of "standard auscultation method" implies adherence to established clinical practices for blood pressure measurement.

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

The document does not describe an adjudication method for reconciling differences between experts for establishing ground truth. The "Standard auscultation method" implies a direct measurement taken by a trained individual, which serves as the reference, rather than a consensus approach among multiple independent observers for establishing 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

There is no indication of an MRMC comparative effectiveness study in the provided text. This device is an automatic blood pressure monitor, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, a standalone performance study was done. The device itself is designed to automatically measure blood pressure and pulse rate using the oscillometric method. The clinical testing comparing its measurements against the standard auscultation method demonstrates its standalone performance.

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

The ground truth used was "Standard auscultation method" measurements. This serves as a direct clinical reference standard for blood pressure.

8. The sample size for the training set

The document does not provide information on the sample size used for the training set of the device's algorithm. The provided information focuses on the clinical validation of the device.

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

The document does not provide information on how the ground truth for the training set was established. This information is typically proprietary to the device manufacturer and not always included in 510(k) summaries.

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