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The Wrist Automatic Blood Pressure Monitor LD-733 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist.

Wrist Automatic Blood Pressure Monitor Model: LD-733

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, which primarily confirms that the device is substantially equivalent to legally marketed predicate devices. It does not detail specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/algorithm-based device as requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about a study design proving the device meets acceptance criteria.

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The Electronic Blood Pressure Monitor LD-568, LD-520, LD-522, LD-587 & LD-528 is device intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the arm.

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The provided text is related to a 510(k) premarket notification for an Automatic Digital Blood Pressure Monitor. It includes information about the device's regulatory classification, intended use, and substantial equivalence determination. However, this document does not contain the detailed study information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies that you requested.

The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has been determined to be as safe and effective as a previously cleared device. This regulatory clearance often relies on demonstrating that the new device meets the same performance standards as the predicate, which would involve testing. However, the specific details of those tests, including the acceptance criteria and study results, are not present in this publicly available document.

To provide the information you requested, access to the full 510(k) submission document or related performance testing reports would be necessary.

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