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The FS-series Wheelchair is manually operated mechanical wheelchair, the FS-series Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position

Foshan Wheelchair is a self-propelled, folding frame, mechanical wheelchair consisting of components typical of most manual wheelchairs. It has large rear wheels with push rims for self-propulsion and small front pivoting casters for turning and stability. It is a lightweight, user adaptable, everyday chair for use both indoors and outdoors.

The provided 510(k) summary for the FS-Series Wheelchair (K041814) does not contain information about specific acceptance criteria or a detailed study proving the device meets certain performance metrics.

Instead, this document is a substantial equivalence determination, which means the FDA has reviewed the device and determined it is substantially equivalent to a legally marketed predicate device (Foshan Machinery & Equipment Import & Export Co. Series Wheel Chair, K992884) in its specifications, performance, and use.

For Class I devices like manual wheelchairs, the regulatory pathway generally relies on demonstrating substantial equivalence to a predicate device that has already met regulatory requirements, rather than requiring extensive new performance studies with specific acceptance criteria. The general controls provisions of the Act apply, including good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

Therefore, the specific information requested in your prompt (e.g., acceptance criteria table, sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance) is not typically found in a 510(k) summary for a device like a mechanical wheelchair seeking substantial equivalence. Such details are more common for novel, higher-risk, or complex devices, especially those involving AI or diagnostic imaging where performance metrics are critical and quantified through rigorous studies.

In summary, based on the provided document, I cannot fulfill the request as the information is not present for this type of device and regulatory submission.

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