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FOR NEAVE STIMULATION AND TOENTIFICATION FOR 26616 WAL ANESTHESIA

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This document is a 510(k) clearance letter from the FDA for a medical device called the "Polystim Nerve Stimulator." It confirms that the device is substantially equivalent to a legally marketed predicate device.

However, this document does NOT contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The letter is primarily a regulatory approval stating that the device can be marketed. It does not include the technical study details one would expect to find when describing acceptance criteria and a study proving device performance.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about the study, as this information is not present in the provided text.

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