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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The MASY23 manual wheelchair is a mechanical wheelchair which is a manually operated, attendant and self-propelled transport device in a health care environment such as a hospital, nursing home or extended care facility. It is intended for medical purpose to provide mobility to persons limited to a sitting position. It can be folded for transport by bring two sides together.

The MASY23 Manual Wheelchair incorporates a main frame, a seat, two hand rims and four wheels. The wheelchair is designed with two small rear wheels and two gearing with hand rim, it can be manually moved forward and in reverse. The wheelchair can support users of up to 136 kg.

The provided text is a 510(k) Premarket Notification from the FDA regarding a Manual Wheelchair (MASY23). It does not describe a study, acceptance criteria, or performance data for an AI/ML-driven medical device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established, as these concepts are not applicable to the clearance of a manual wheelchair.

The document focuses on demonstrating substantial equivalence of the manual wheelchair to a predicate device through non-clinical performance and biocompatibility testing, primarily against ISO standards.

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