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Measures automatically human's Systolic, Diastolic blood pressure and heart rate using the oscillometric method. All values can be read out in one LCD Panel.

Full Automatic (NIBP) Blood Pressure Monitor

The provided document is a 510(k) clearance letter from the FDA for a blood pressure monitor, specifically referencing K990807, HL148, and HL168. This type of document is a regulatory approval, not a detailed study report. Therefore, it does not contain the kind of detailed information about acceptance criteria, study methodology, sample sizes, expert qualifications, or ground truth establishment that you are requesting.

The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has met the necessary regulatory hurdles for market entry based on comparison to existing approved devices. It does not provide the specifics of the performance studies conducted to establish that equivalence or to meet specific performance acceptance criteria beyond the general statement of substantial equivalence.

To answer your questions, one would typically need access to the full 510(k) submission or the study reports cited within it, which are not part of this public clearance letter.

Therefore, I cannot provide the requested information based solely on the text provided.

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