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The Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Blood Pressure Monitors are designed to provide signals from which systolic and diastolic pressures can be derived through the use of the oscillometric method. The devices also measure pulse rate.

Mars MS-900S, MS-900SFM & MS-900SPM Auto Inflation Wrist Digital Blood Pressure Monitors

The provided text is a 510(k) clearance letter from the FDA for the Mars Medical Products MS-900S, MS-900SPM, and MS-900SFM Automatic Blood Pressure Monitors. It confirms the substantial equivalence of these devices to existing ones. However, this document does not contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a clinical study.

The letter acknowledges the submission and clearance but does not provide the underlying data or results of the performance studies. Therefore, I cannot extract the information requested.

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