(133 days)
The power wheelchair is a motor driven, indoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
The power wheelchair, model name: D10, D12, D15, D17, D20, D37, is an indoor/outdoor, foldable, battery-operated 2-wheel (rear-wheel drive) powered wheelchair. It consists of two parts: the electrical part and the wheelchair main body. The electric part includes brushless motor, electromagnetic brake system, controller, rechargeable Lithium-lon battery and off-board battery charger. The main parts of the wheelchair include front wheels, rear wheels, frame, armrest, backrest and seat cushion. The control system, including the controller handle (joystick), is equipped on the control pad that attaches to the one of the arm rests. When the joystick is released, the electromagnetic brakes will be actuated, and the power wheelchair is slowed to a stop. The power wheelchair, model name: D10, D12, D15, D17, D20, D37, can be controlled by joystick or remote controller via Bluetooth Low Energy (BLE) wireless communication interface. The user can lock and unlock the device remotely via the BLE interface using the remote controller. For safety, controller rocker control is priority over the remote control by design. The power wheelchair (Model D10, D12, D15, D17, D20, D37) can be folded/ expanded manually. The Left and right handrails (joystick) can be interchange. The D17 power wheelchair has an additional headrest and its seat unit can be adjusted by a remote control key to a largest angle of 30°.
The provided text is a 510(k) Premarket Notification from the FDA for a Power Wheelchair. It describes the device, compares it to predicate devices, and outlines the non-clinical testing performed to establish substantial equivalence. However, it does not contain information about a study proving the device meets acceptance criteria related to AI/ML performance, human reader improvement with AI assistance, or expert ground truth establishment for medical imaging or similar AI applications.
The document explicitly states:
- "No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the power wheelchair to its predicate device." (Page 17, Section IX)
- The comparison tables (Table 1, Table 2, Table 3) detail physical, mechanical, and electrical characteristics, and safety standards met (ISO, IEC, EMC, biocompatibility). These are engineering and safety performance criteria for a wheelchair, not AI/ML performance.
Therefore, I cannot provide the requested information regarding AI/ML acceptance criteria and a study that proves the device meets those criteria, as the provided text pertains to a power wheelchair and not a medical device involving AI/ML for diagnostic or therapeutic purposes.
If you have a document describing an AI/ML medical device and its validation study, please provide that, and I will be able to answer your questions.
§ 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).