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The Sunrise Medical Quickie Rhythm Powered Wheelchairs intended use is to provide mobility to persons limited to a seating position that have the capability of operating a powered wheelchair. The Quickie Rhythm Power Wheelchairs provide an optional means of mobility for physically challenged people.

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This document is a 510(k) clearance letter from the FDA for a powered wheelchair, not a study evaluating a medical device's performance against acceptance criteria. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, etc.) is not present in the provided text.

The letter simply states that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed. It does not contain any performance data or study results.

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The Quickie Rhythm & Groove Series Power Wheelchairs with Quickie/Delphi Controls intended use is to empower physically challenged individuals by providing a means of mobility.

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This is a notification from the FDA regarding a 510(k) premarket notification for "QuickieRhythm & Groove Scries Power Wheelchairs with Ouickie/Delphi Controls". This document is a regulatory approval, not a technical study report for an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available within the provided text.

The document confirms that this device is a powered wheelchair, not an AI/ML diagnostic or prognostic device that would typically involve acceptance criteria and a study to prove performance as described in your request. The FDA's determination is based on the device being "substantially equivalent" to legally marketed predicate devices, not on a detailed analysis of performance against specific acceptance criteria for AI algorithms.

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