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The model MW-300 series wrist pressure monitor is intended for use for the noninvasive measurement of blood pressure (systolic and diastolic) and pulse rate in adults, in a home use setting. Use may be initiated by the individual or as part of a hypertension monitoring and management program supervise by a health care provider.

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The provided text is a 510(k) premarket notification letter from the FDA for a Wrist Digital Blood Pressure Monitor (Digital Sphygmomanometer), Model MW-300 Series. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding the acceptance criteria, the study that proves the device meets the acceptance criteria, or any of the specific details requested in your prompt (e.g., sample size, ground truth, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

Therefore, I cannot provide the requested table or answer the specific questions based on the input text. The document is a regulatory approval letter, not a detailed study report.

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