(148 days)
The Cheetah Wheelchair is designed for children who have physical impairments that require the use of a device to assist them with their mobility needs. This device is intended solely for pediatric use.
Not Found
The provided document is an FDA 510(k) clearance letter for a medical device: the "Cheetah Wheelchair." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance) of the kind requested.
The letter is a regulatory document confirming that the FDA has reviewed the manufacturer's premarket notification and determined that the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device subject to general controls.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study proving the device meets them because this information is not present in the provided text.
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).