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Wrist Measurement Electronic Blood Pressure Monitor is for use by medical professionals or at home and is a non-invasive blood pressure measurement system intended to measure the diastolic and systolic blood pressures and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to 6.1023 inches to 9.8425 inches.

Wrist Measurement Blood Pressure Monitor is a Non-invasive blood pressure measurement system for only one person each time. Based on oscillometric and silicon integrate pressure sensor technology, the device is used to monitor systolic, diastolic blood pressure and pulse rate which will be shown on a LCD with an electronic interface module. Buckling a cuff around a wrist automatically inflated and released by an internal pump, the device can analyze the signals promptly and display the results and remember circularly for some sets of data. It can storage and show 60 times measuring result with the day and time. Specially, it has the function of blood pressure level classification.

The provided text describes the clinical tests and acceptance criteria for the Wrist Measurement Electronic Blood Pressure Monitor (Models: KD-791, KD-792, KD-793, KD-795, KD-796, KD-797, KD-798).

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated for the clinical accuracy test. The document only mentions "Clinical tests were performed."
• Data Provenance: Not specified (e.g., country of origin, retrospective or 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 specified.
• Qualifications of Experts: Not specified. For blood pressure monitoring, ground truth is typically established by trained medical personnel using a reference sphygmomanometer.

4. Adjudication method for the test set:

• Not applicable/Not specified. For automated blood pressure monitors, the device's readings are directly compared to the reference standard, rather than involving expert adjudication of "results."

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:

• Not applicable. This device is an automated blood pressure monitor and does not involve human "readers" or AI assistance in the interpretation of complex medical imagery or data. Its primary function is to directly measure and display blood pressure and pulse rate.

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

• Yes, performance evaluation was done in a standalone manner. The device is designed to automatically measure and display readings without real-time human intervention in the measurement process itself. The clinical tests assessed the accuracy of the device's measurements against a recognized standard (ANSI/AAMI SP10-2002).

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

• For the blood pressure accuracy, the ground truth would be established by reference measurements taken simultaneously or sequentially by trained personnel using a validated, traditionally accepted method (e.g., a mercury sphygmomanometer or another validated reference device) as dictated by the ANSI/AAMI SP10-2002 standard.

8. The sample size for the training set:

• Not applicable/Not specified. This device is based on oscillometric technology and appears to be a deterministic algorithm rather than a machine learning model that would require a separate "training set" in the conventional sense. The "training" would be more akin to calibration and design optimization based on engineering principles and the chosen measurement method.

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

• Not applicable for the reason stated above. If any iterative development involved comparing prototype readings to known values, those known values would follow the same ground truth principles as outlined in point 7.

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