(244 days)
Quickie Powered Wheelchairs empower physically challenged persons by providing a means of mobility.
Quickie powered wheelchairs consist of typical features found on any wheelchair, such as push handles, adjustable armrests, backrest, seat frame and cushion, footrests, and casters. Because these are motorized wheelchairs, they also consist of joy stick controller, motors, brakes, batteries and drive wheels.
The provided text is a Summary of Safety and Effectiveness for the Quickie Powered Wheelchair with Penny and Giles Controller, a medical device submission. It describes the device, its intended use, and compares it to predicate devices. However, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria, specifically:
- Table of acceptance criteria and reported device performance: This is absent. The document only states that testing "demonstrate that the wheelchair performs as the predicate device" and "according to specification," but no specific criteria or quantified performance metrics are provided.
- Sample size and data provenance for the test set: Not mentioned for any testing.
- Number of experts and their qualifications for ground truth: Not applicable, as this is hardware testing, not an AI or diagnostic study requiring expert consensus.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not conducted, as this is a physical device and controller modification, not a diagnostic imaging or AI-assisted interpretation system.
- Standalone (algorithm only) performance: Not applicable, as it's a physical controller; its performance is always "in-the-loop" with the wheelchair.
- Type of ground truth used: For non-clinical testing, the "ground truth" would be engineering specifications and safety standards, but these are not explicitly detailed.
- Sample size for the training set: Not applicable, as this is hardware testing, not a machine learning model.
- How ground truth for the training set was established: Not applicable.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical testing of programmable parameters and electromagnetic compatibility (EMI). The core assertion is that the new P&G controller does not change the core wheelchair specifications and performs comparably to the previous Dynamics controller, which is already on the market.
Specific findings from the document related to testing:
- Non-clinical testing: Performed on all programmable parameters, including:
- Maximum and minimum forward and reverse speeds
- Maximum and minimum turn speeds
- Maximum and minimum acceleration and deceleration
- Maximum and minimum turn acceleration and deceleration
- Comparative testing: Regarding speed, acceleration, and brake distance, results "demonstrate that the wheelchair performs as the predicate device with the Dynamics controller."
- Electromagnetic compatibility testing: Performed, and results "demonstrate that the wheelchairs pass the 20 V/m EMI test."
- Software validation information: Includes requirements, design, development, verification, validation, hazard analysis, and mitigation associated with controller safety.
In summary, the document states that the device meets "specifications" and performs "as the predicate device," but it does not provide the quantitative acceptance criteria or detailed study results that your prompt requests. The nature of this submission (a modification of a physical device's controller) does not lend itself to many of the AI-specific questions in your prompt.
§ 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).