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Wrist type non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment.

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The provided text is a 510(k) clearance letter from the FDA for the Rossmax Wrist Type Blood Pressure Monitor, Models B150 and Q400. This document grants market clearance based on substantial equivalence to a predicate device, rather than providing a detailed study report with acceptance criteria and performance data.

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.

The document states that the device is a "Wrist type non-invasive blood pressure system that measure systolic, diastolic, and pulse rates for adult consumers in a home environment." The FDA's determination of substantial equivalence implies that the device is expected to meet the performance standards set by its predicate device, but the specifics of those standards and the device's performance against them are not detailed in this clearance letter.

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