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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Y.E.S. Powered Wheelchair, T180

The provided document is a 510(k) premarket notification letter from the FDA for a powered wheelchair (Y.E.S. Powered Wheelchair, T180). This type of document declares substantial equivalence to a predicate device and allows market entry. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment—these are typically found in the 510(k) submission itself, which is not provided here.

Therefore, I cannot answer your request based on the provided text. The document is administrative in nature, confirming regulatory clearance.

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The device is intended for medical purposes to provide mobility to persons restricted to a sitting position.

Y.E.S. Powered Wheelchair, T200

I am sorry, but the provided text does not contain information on acceptance criteria, study details, or device performance for the Y.E.S. Powered Wheelchair, T200. The document is an FDA 510(k) clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not include the specifics of performance testing or clinical studies.

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