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The Mechanical Wheelchair is intended for use to provide mobility to persons limited to a sitting position, but able to operate a manual wheelchair.

Pacific Suppliers, Inc. Mechanical Wheelchair

The provided text is a 510(k) premarket notification letter for a mechanical wheelchair, not a study evaluating a device's performance against acceptance criteria. Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This indicates that the FDA's decision is based on a comparison to a predicate device, and not on a detailed study of the device's performance against specific acceptance criteria in the manner typically described for diagnostic or algorithmic devices.

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