(30 days)
This wheelchair is designed as a transport base for ... . . pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.
Spectrym Small Fry Manual Folding Mobility Wheelchair
This document is a 510(k) premarket notification from the FDA, approving a "Manual Folding Mobility Wheelchair". It does not contain information about acceptance criteria or a study proving the device meets said criteria, in the way one would describe for a diagnostic or AI-powered medical device.
The document is a regulatory approval for a physical medical device (a wheelchair), not a software or diagnostic device. Therefore, the questions related to performance metrics like sensitivity, specificity, sample sizes, expert ground truth, MRMC studies, or training sets are not applicable to this type of submission.
The FDA's approval for this device is based on a determination of "substantial equivalence" to devices already marketed, not on a clinical performance study with statistical endpoints.
Therefore, I cannot provide the requested information from 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).