(18 days)
The intended use of the subject device as well as the predicate device empowers physically challenged persons a means of mobility. This includes temporary and permanent conditions in all ages, including but not limited to arthritis, paraplegic, multiple sclerosis, and other debilitating conditions. Our device and the predicate device provide the same function for occupants who are unable to move due to injuries or other medical conditions.
Manual Wheelchair
This document is a 510(k) clearance letter from the FDA for a manual wheelchair. It is not a study document that describes acceptance criteria and device performance data for a medical device that relies on AI or machine learning.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, training set size, and ground truth establishment for the training set).
The document states that the manual wheelchair is substantially equivalent to legally marketed predicate devices, meaning it has been deemed as safe and effective as a device already on the market without requiring new clinical trials or extensive performance studies typically seen with novel, often AI-driven, technologies.
§ 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).