(35 days)
This wheelchair is to provide mobility to persons limited to a sitting position being transported either by an attendant or self-propelled.
This device is designed to be a typical manual wheelchair for use in an aquatic center setting.
The Stainless Steel Aquatic Wheelchair is a non-rigid style, folding wheelchair. The wheelchair is suitable to provide mobility indoors or in wet conditions on a firm surface free of obstructions.
Construction is typical for this style of wheelchair. Our chair uses a crossbraced, welded, stainless steel frame with slung fabric (seat and back); swing back armrests and removable foot riggings. The chair uses 8-inch caster wheels at the front for steering with rear push handles for attendant assisted propulsion and 24-inch rear drive wheels with hand rims for self-propulsion. Lever style wheel locks are used on this chair.
All parts on our wheelchair are fabricated from stainless steel and selected plastics suitable for use in a swimming pool environment. The chair can be submersed in pool water without any harmful effects.
Upholstery meets California Technical bulletin CAL 117 standard for flame retardancy.
Users manual provides information on warnings, cautions maintenance and operation instructions.
The provided document is a 510(k) Summary for a "Stainless Steel Aquatic Wheelchair" and a clearance letter from the FDA. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI-powered medical device.
The document discusses:
- The submitter's name and address.
- The product name, generic name, model variations, and FDA classification.
- Predicate devices (Tracer EX Manual Wheelchair and Silhouette 300 Manual Wheelchair).
- Intended use and description of the device.
- A statement of substantial equivalence to predicate devices, noting the material differences for aquatic use.
- The FDA's decision to clear the device for marketing.
Therefore, I cannot fulfill your request for the following information based on the provided text, as it pertains to AI/algorithm performance and clinical studies of that nature, which are not present in this document:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This document describes a traditional mechanical medical device, not an AI or algorithm-based one.
§ 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).