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Model CH-311B Blood Pressure Meter is intended to be used for oscillometric measurement of systolic and diastolic blood pressure and pulse and are intended to be sold at a retail shop and 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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This document is a 510(k) clearance letter from the FDA for a blood pressure monitor, not a study report. Therefore, it does not contain the detailed information requested about acceptance criteria, study methodology, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The letter confirms that the device, Model CH-311B Blood Pressure Monitor, is substantially equivalent to legally marketed predicate devices and can be marketed for over-the-counter use for oscillometric measurement of systolic and diastolic blood pressure and pulse for checking personal health conditions at home. While it mentions the device meets general controls provisions and potentially additional controls for Class II devices, it does not provide the specific performance data or the study details to prove this.

To answer your request, one would typically need access to the actual 510(k) submission or a separate study report for the device.

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