(112 days)
These Manual Wheelchairs are to be used by people needing mobility assistance. The manual Wheelchairs will be used for personal use, and for commercial use in venues such as Theme parks, Airports, and Hospitals.
Not Found
The provided document is a 510(k) clearance letter from the FDA for a manual wheelchair (Momentum No. FS008 Wheelchair). This type of document is a regulatory approval, not a scientific study report. It states that the device is "substantially equivalent" to legally marketed predicate devices.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, as typically found in a clinical or performance validation study report for an AI/diagnostic device.
Specifically, it doesn't provide:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication methods for test sets.
- Information on MRMC comparative effectiveness studies.
- Information on standalone algorithm performance.
- Type of ground truth used.
- Sample size and ground truth establishment for a training set.
The FDA 510(k) process for a manual wheelchair primarily focuses on demonstrating substantial equivalence in terms of safety and effectiveness to an already approved device, rather than requiring extensive new performance studies with detailed statistical metrics as would be expected for a novel diagnostic or AI-powered medical device.
§ 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).