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The Winner Transfer Wheelchair is a manually operated wheelchair that is intended for medical purposes to provide mobility to persons restricted to a sitting position.

The Winner Transfer Wheelchair is a manual wheelchair used by individuals for whom walking is difficult or impossible and who need assistance in transport. The Winner Transfer Wheelchair is propelled manually by the user propelling the wheels or being pushed by an assistant. The Winner Transfer Wheelchair has the standard attributes of the predicate wheelchair, such as an aluminum frame with flip away, height adjustable and retractable armrests, an adjustable upholstered tension back and flip down back, and a swing away and removable footrest.

The Winner Transfer Wheelchair has an accessory, the Kingfisher 125T Retractable Kit, which can be attached to either the left side or the right side of the Winner Transfer Wheelchair. The Retractable Kit serves to allow the rear wheel to be retracted (moved back in a linear motion), thereby opening the side distance in front of the wheel to permit easier lateral transfer. Whereas in most wheelchairs, the rear wheel is obstructing placement of a Transfer Board which is often used during lateral transfer. When the rear wheel is retracted using the Kingfisher 125T Retractable Kit, it is easier for the user to positioning the transfer board. The base wheelchair can be fitted with a left or right retractable kit.

The document does not describe acceptance criteria and a study that proves a device meets them in the context of an AI/ML device. Instead, it is a 510(k) premarket notification for a "Winner Transfer Wheelchair." The document details the substantial equivalence of this manual wheelchair to a predicate device, focusing on mechanical and functional characteristics rather than AI/ML performance.

Therefore, I cannot provide the requested information. The concepts of "test set," "ground truth," "MRMC comparative effectiveness study," and "standalone algorithm performance" are not applicable to the content of this document.

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