(42 days)
The intended use of the Litestream 500E is to provide mobility to persons limited to a seated position that are capable of operating a mechanical wheelchair.
The Litestream 500E mechanical wheelchair enhances the mobility of users whom are partially or fully non-ambulatory.
The Litestream 500E mechanical wheelchair is lightweight and designed to provide mobility based on the user's capabilities and needs, with propulsion by the user or an attendant. To better adapt to individual needs, the Litestream 500E is available in various seat sizes, and features component adjustments to enhance fitting and performance.
With hand-rim drive wheels in the rear, and pivoting front casters, the Litestream 500E steers according to typical mechanical wheelchairs, and features common wheelchair components, including a seat frame, backrest, armrests, legrests, and wheel locks.
The Litestream 500E performs well indoors, and maintains its performance on firm, smooth, surfaces, as well as those that are free of steep angles and obstacles. For durability and less weight, the frame material is aluminum, with a seat and backrest upholstery fabric that meets the California CAL177 Standard for flammability. The Litestream 500E Owner's Manual contains descriptions and specifications toward meaningful use, operation, and care of the wheelchair.
This document is a 510(k) premarket notification for the Litestream 500E Mechanical Wheelchair. As such, it does not contain the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML medical device.
The provided text describes a traditional mechanical medical device (a wheelchair) and its substantial equivalence to a predicate device. The information requested (acceptance criteria, test/training sets, ground truth, expert qualifications, adjudication, MRMC studies, standalone performance, etc.) are concepts relevant to the evaluation of AI/ML-based medical devices, which are not applicable to the Litestream 500E Mechanical Wheelchair as described here.
The document focuses on:
- Device Description: A mechanical wheelchair, its components, and general function.
- Intended Use: To provide mobility to persons limited to a seated position, capable of operating a mechanical wheelchair, and who are partially or fully non-ambulatory.
- Comparison to Predicate Device: The Sunrise Medical Quickie (K850536).
- Non-Clinical Testing: A list of ANSI/RESNA standards related to wheelchair performance (static stability, brakes, dimensions, impact, fatigue, strength, flammability, etc.).
- Conclusion: The Litestream 500E is substantially equivalent to the predicate device because it has the same intended use and similar technological characteristics, and differences do not raise new questions of safety or effectiveness.
Therefore, I cannot provide the requested information about acceptance criteria and studies for an AI/ML device based on this document. The document explicitly states "Discussion of Clinical Testing Performed: N/A".
§ 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).