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BP 700-WF is a non-invasive blood pressure measurement device intended to measure systolic, diastolic BP 700-Wr is a non-invasive blood pressure modult individual over age 18, at home by using a non-invasive blood pressure and puise rate of an addit managed around the upper arm. The cuff circumference is limited to 9"-13" for Arm type.

The device can transmit the readings through wireless communication for record archiving and review.

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The provided document is a 510(k) clearance letter from the FDA for the Carematix Inc. Blip model bp-700wf, a non-invasive blood pressure measurement system. As such, it does not contain the detailed study information required to answer your questions about acceptance criteria, study design, expert qualifications, or ground truth establishment.

This type of FDA letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics, and raises no new questions of safety and effectiveness. The actual performance data and study details would be found in the manufacturer's 510(k) submission document, which is typically much more extensive than this clearance letter.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the full 510(k) submission document for K123020, or a summary of its performance data and clinical study details.

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