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The device is a power wheelchair intended to provide mobility to persons restricted to a sitting position.

The device is a power wheelchair.
Common Name: Powered Wheelchair
Trade Name: "SupaChair" Powered Wheelchair
Classification Name: Powered Wheelchair
Regulation Number: 890.3860
Product Code: ITI
Device Class: Class 2
Model: COMBI 18/ COMBI 20/ COMBI 18SP/ COMBI 20SP

The provided text is a 510(k) premarket notification for a powered wheelchair, the "SupaChair." It outlines the device's technical specifications, intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not describe acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a clinical study for an AI/ML powered device.

The information provided relates to a physical medical device (a powered wheelchair), not an AI/ML algorithm. Therefore, many of the requested elements (like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the-loop) performance," "ground truth establishment," "training set sample size," etc.) are not applicable to the content of this document.

The document focuses on demonstrating substantial equivalence to an existing predicate device based on technical characteristics and non-clinical testing (ISO standards for powered wheelchairs), rather than performance metrics of an AI/ML algorithm against a defined ground truth.

Therefore, I cannot extract the requested information from the provided text as it is not present. The document focuses on mechanical, electrical, and physical performance of a wheelchair, not the analytical or clinical performance of a diagnostic AI.

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