(51 days)
These manual wheelchairs are to be used by persons requiring assistance for mobility. The TC series (Tilt Recliner) are for self-propelled by a care giver. These wheelchairs can be use for everyday in the home or outdoors, hospitals, or institution.
TC Series (Tilt Recliner) [Mechanical Wheelchair]
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a series of wheelchairs. It does not contain information about the acceptance criteria or a study proving device performance as typically expected for medical devices involving algorithmic performance or diagnostic capabilities.
The letter explicitly states that the devices (manual wheelchairs) are "substantially equivalent" to predicate devices marketed before May 28, 1976. This type of clearance primarily focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or different characteristics that do not raise new questions of safety and effectiveness.
Therefore, the requested information elements (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to the content of this FDA letter. The letter is about regulatory clearance for mechanical wheelchairs, not about a study assessing the performance of software or an AI-powered diagnostic device against specific metrics.
§ 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).