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To provide an optional means of mobility for physically challenged people.

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The provided text is a 510(k) clearance letter from the FDA for a device named "Coach 777-3," which is a motorized three-wheeled vehicle. This document does not contain any information regarding acceptance criteria for device performance, reports of device performance, study designs, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document solely states that the FDA has reviewed the premarket notification and found the device substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested information based on the input text.

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