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The intended use of Trevair Chair Adult is to provide mobility to persons with physical limitations limited to a sitting position. It is intended for indoors and outdoor use by individuals of all ages who are physically challenged. Designed and handcrafted in Minden Nevada, USA, specifically for any individuals who want or need plush suspension at an uncompromising wheel chair weight.

Trevair Chair Adult is a self-propelled, rigid 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 light weight, user adaptable, everyday chair for use both indoors and outdoors.

This document is a 510(k) summary for the Trevair Chair Adult, a manual wheelchair. It does not describe a device that uses artificial intelligence (AI) or machine learning, nor does it present any studies involving acceptance criteria based on performance metrics like sensitivity, specificity, or F1-score.

The document discusses the substantial equivalence of this medical device (a manual wheelchair) to predicate devices, focusing on its specifications, performance, and intended use as required for FDA 510(k) clearance.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/ML device, as this document does not contain that type of information.

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