(14 days)
The Quickie MWD Series II Power Wheelchair's intended use is to empower physically challenged individual by providing a means of mobility.
Not Found
The provided text is related to a 510(k) premarket notification for a powered wheelchair (Quickie MWD Series II Power Wheelchair). This type of document, particularly from 2006, focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance studies with acceptance criteria, expert ground truth, or AI-related metrics like those listed in the prompt.
Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, and training set ground truth) is not available in the given document.
The document primarily states:
- Device Name: Quickie MWD Series II Power Wheelchair
- Intended Use: To empower physically challenged individuals by providing a means of mobility.
- Regulatory Status: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
The FDA's review in 2006 for this type of device would have focused on engineering specifications, safety testing (e.g., electrical safety, mechanical stability, durability), and performance characteristics compared to a predicate device, rather than the kind of clinical performance study with AI-specific metrics that your prompt asks for.
§ 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).