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Stroke Rehab by Muscle Re-education Relaxation of Muscle Spasms Prevention of retardation of disuse atrophy Increase local blood circulation Muscle re-education Maintaining or increasing range of motion

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The provided document is a 510(k) clearance letter from the FDA for the NeuroMove NM900 device. It states that the device is "substantially equivalent" to legally marketed predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data that would be used to prove the device meets specific acceptance criteria.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth details.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This indicates a comparison to existing devices, not necessarily a new clinical trial proving specific performance against set acceptance criteria in a standalone manner.

To provide the requested information, the actual 510(k) submission (which includes the supporting data and analysis) would be required. The document provided is the outcome of that review, not the review itself.

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