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The intended use is to provide mobility to persons limited to a seated position.

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This looks like a 510K clearance letter for a powered wheelchair, not an AI device. As such, the typical information requested about AI/ML device performance, such as acceptance criteria based on accuracy metrics, sample sizes for test and training sets, expert adjudication, MRMC studies, or standalone performance, is not applicable or present in this document.

The document 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 the approval is based on substantial equivalence to existing devices, not on a detailed study of novel AI performance.

Therefore, I cannot provide the requested information.

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