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The Citizen Model CH-658 blood pressure meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The device detects the appearance of irregular heartbeat during measurement, and gives a warning signal with the reading once the irregular heartbeat is detected. The device is intended to be used for checking personal health condition at home, and not primarily under the order or direction of a physician.

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The provided text is a 510(k) clearance letter from the FDA for the "Model CH-658 Blood Pressure Meter." It outlines the device's regulatory status and indications for use, but it does not contain information about acceptance criteria, specific performance studies, sample sizes, ground truth establishment, or expert evaluations.

Therefore, I cannot fulfill your request for a description of the acceptance criteria and a study proving the device meets them based only on the input provided. The document confirms the device is substantially equivalent to a predicate device, which implies it has met some performance standards, but those specific details are not present.

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