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The EIKON automatic digital blood pressure monitor, Model HD-400M, is a noninvasive blood pressure measurement system intended to measure the systolic and diastolic blood pressures and pulse rate of an adult individual, over age 16, at home by using a non-invasive technique in which an inflatable cuff is wrapped around the wrist. The cuff circumference is limited to be 5.3"-8.5".

EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR HD-400M

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and study details. The document is a 510(k) clearance letter from the FDA for a blood pressure monitor, confirming its substantial equivalence to a predicate device. It briefly mentions the device name, regulation number, and intended use, but it does not include:

• A table of acceptance criteria and reported device performance.
• Details about the sample size for test sets or data provenance.
• Information on experts used to establish ground truth or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm-only) performance data.
• The type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set or how its ground truth was established.

The document essentially states that the device can be marketed due to its substantial equivalence to previously approved devices, rather than providing a detailed technical or clinical validation study report.

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