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This is an FDA Premarket Notification (510(k)) clearance letter for a manual wheelchair. This type of letter does not include acceptance criteria for device performance, or details of a study proving such criteria are met. The 510(k) pathway is for demonstrating substantial equivalence to a legally marketed predicate device, primarily focusing on safety and effectiveness similarities rather than detailed performance metrics from a new study.
Therefore, I cannot extract the requested information from the provided document. The sections you asked for, such as acceptance criteria table, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, and training set information, are typically found in detailed scientific studies, clinical trial reports, or performance testing summaries, which are not part of this 510(k) clearance letter.
§ 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).