(119 days)
Not Found.
Mechanical Wheelchair "CHUMP", "KRYPTO"
This document is a 510(k) premarket notification letter from the FDA regarding a mechanical wheelchair. It explicitly states that the device is "substantially equivalent" to legally marketed predicate devices and is classified as Class I.
The information provided does not describe an acceptance criteria and study for a device that uses AI or machine learning. It pertains to a physical product (a wheelchair) and its fire retardancy testing, which is a physical property test, not an AI performance study.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, MRMC study, or standalone performance) because this document does not contain any information related to AI or machine learning performance.
The only relevant "acceptance criteria" mentioned is the "Fire retardant test accomplished at Swedish Handicapped Institute to I.S.O. 7176 under umbrella of ISO 9000/9001" and "All fabric is in accordance to California specification 117." However, these are not AI-specific performance 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).