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The Meditech ABPM-05 Ambulatory Blood Pressure Monitor automatically measures the systolic and diastolic arterial blood pressure and the pulse rate of adult patients under ambulatory circumstances using the standard oscillometric method with a standard upper arm cuff, sequentially as preprogrammed by the adjoining software. The device is intended for use with the standard indications and contraindications for ambulatory blood pressure monitoring.

Meditech ABPM-05 Ambulatory Blood Pressure Monitor

The provided text is a 510(k) clearance letter from the FDA for the Meditech ABPM-05 Ambulatory Blood Pressure Monitor. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information about acceptance criteria, device performance results, sample sizes for testing or training, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The letter focuses on regulatory clearance based on substantial equivalence, not on detailed study results.

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