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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 document is a 510(k) clearance letter from the FDA for the Rossmax MediPro Model 10 and 60, and MediCare Model 10 and 60 Blood Pressure Monitors. This type of document does not contain the detailed study information required to answer questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.

The letter confirms that the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It lists the trade name, regulation number, regulation name, regulatory class, and product code. It also includes an "Indications for Use Statement" which specifies that the devices are "Non-invasive blood pressure systems that measure systolic, diastolic, and pulse rates for adult consumers in a home environment."

To answer the requested questions, one would need to review the actual 510(k) submission (which is typically a much larger document than this clearance letter) or the clinical study reports submitted as part of that application. The clearance letter itself does not provide the specific performance data or study methodology.

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