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Mobility assistive device for indoor use and outdoor use on mild terrain. Not used as a transportation vehicle on roads and freeways used by cars.

Motorized three wheeled vehicle

The provided text is a 510(k) premarket notification letter from the FDA regarding a device named "EasyTravel," which is a motorized three-wheeled vehicle. This document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device EasyTravel and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified"

This indicates that the device was cleared based on substantial equivalence to a predicate device, not on meeting specific performance acceptance criteria from a new clinical study or AI algorithm validation.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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