(60 days)
The Quickie Interchange FWD w/ Lift Power Wheelchair's intended use is to empower physically challenged individuals by providing a means of mobility.
The Quickie Interchange FWD w/ Lift Power Wheelchair is a High End/Mid-Range Rehabilitation type Power Chair Base design that offers the functionality to be used as a Front Wheel drive or a Rear Wheel drive base without changing major frame parts. The system allows for reassembling parts that will for either front or rear wheel drive function. The design will offer a modular approach within the drive base as intve adopt various seating & wiring elements. The device utilizes components typically found on most wheelchairs, including but not limited to rigid seat frame, backrest, product armrests, cushion, footrests and casters. Accessories that may be added after market include items such as positioning belts, backpacks, seat pouches, oxygen taak holders, IV poles, etc. As a motorized wheelchair, it also contains a controller, joystick, motor, brakes, drive wheel and batteries. This product is appropriate for use by any individual who has the ability to drive a powered wheelchair without having to utilize the services of an attendant. Sunrise Medical makes no claim as to the therapeutic effectiveness of the product. Sunrise Medical's only claim relates to the ability of the product to provide an optional means of mobility for physically challenged people.
The provided text describes a 510(k) premarket notification for a powered wheelchair, not an AI/ML medical device. Therefore, the information typically found for AI/ML device studies (such as diagnostic performance metrics, expert reader studies, and ground truth establishment methods) is not applicable or present in this document.
The document discusses the substantial equivalence of the "Quickie Interchange FWD w/ Lift Power Wheelchair" to a predicate device, focusing on similar technological characteristics and adherence to relevant industry standards for safety and performance.
However, I can extract the closest analogous information based on the 510(k) submission.
Acceptance Criteria and Device Performance (Analogous for a Non-AI Device):
| Acceptance Criteria (from regulation/standards) | Reported Device Performance |
|---|---|
| Device must meet appropriate ISO & ANSI/RESNA standards and other applicable requirements. | Device "passed all test protocols" to appropriate ISO & ANSI/RESNA standards. |
| Device must meet performance criteria for power and control systems as per ISO 7176-14:1997. | "The Quickie Interchange FWD v/ Lift Power Wheelchair met the required performance criteria and functioned as intended" in accordance with ISO 7176-14:1997 ("Wheelchairs - Part 14. Power and Control Systems for Electric Wheelchairs - Requirements and Test Methods"). |
| Device must be substantially equivalent to the predicate device in design, function, features, and performance. | Analysis of comparison of design, function and features to the predicate device (Invacare Arrow FWD Power Wheelchair) and testing results demonstrate the device to be "substantially equivalent ... in terms of meeting performance criteria and functioning as intended." The device "does not raise any new issues of safety and effectiveness." |
| Intended use: provide mobility to persons limited to a seating position, capable of operating a powered wheelchair. | The device's intended use is consistent with providing mobility to physically challenged individuals ("empower physically challenged individuals by providing a means of mobility"). |
Information Not Applicable or Not Found in the Provided Text (for an AI/ML-focused request):
- Sample size used for the test set and data provenance: Not applicable. The "test set" here refers to physical testing against engineering standards rather than diagnostic performance on a dataset.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth for a powered wheelchair's performance is adherence to engineering specifications and safety standards, not expert diagnostic labels.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for AI-assisted diagnostic performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
- The type of ground truth used: For this device, the "ground truth" is compliance with established engineering and safety standards (e.g., ISO, ANSI/RESNA) and the functional specifications of the device itself.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a physical medical device (a powered wheelchair), not an AI/ML diagnostic or therapeutic device. Therefore, the specific criteria for evaluating AI/ML models are not relevant to this submission. The "study" described is the non-clinical testing against established physical performance and safety standards.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).