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Folding Mobility Wheelchair. This wheelchair is designed as a transport base for pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

Folding Mobility Wheelchair

The provided text is a 510(k) premarket notification letter from the FDA for a wheelchair, the "Spectrum Libre Wheelchair." This document is not a study report and therefore does not contain information about acceptance criteria, device performance, sample sizes for training or test sets, expert qualifications, or adjudication methods for an AI/ML device.

The letter explicitly states:
"We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance criteria demonstrated through a clinical study as would be required for an AI/ML device.

Therefore, I cannot provide the requested information from this document.

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