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The intended use of Travel Ease Electric Scooter, Pioneer 4 is to provide mobility to adult persons limited to a sitting position and capable to operate a few simple controls.

Travel Ease Electric Scooter, Pioneer 4

I am sorry, but the provided text from the FDA 510(k) summary for the "Travel Ease Electric Scooter, Pioneer 4" does not contain information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any of the other specific details regarding a medical device's performance evaluation as requested in your prompt.

The document is a clearance letter from the FDA, confirming that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It discusses regulatory matters such as the device's classification, general controls, and compliance with regulations, but it does not include performance data or studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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