(149 days)
The power wheelchair is a motor driven, indoor and outdoor 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: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, 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: DC01, DC02, DC03, DC05, DC06, DC07L, DC08L, DC09L, DC10L, 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 wheelchair can be folded/expanded manually. The Left and right handrails (joystick) can be interchange.
The provided text describes a 510(k) submission for a power wheelchair and does not contain information about acceptance criteria and a study that proves a device meets those criteria in the context of an AI/ML medical device.
The document is a letter from the FDA regarding a premarket notification for a Power Wheelchair. It focuses on the substantial equivalence of the proposed device to legally marketed predicate devices based on non-clinical performance testing (bench testing), adherence to ISO standards for wheelchairs, and material biocompatibility.
Therefore, I cannot extract the requested information (such as AI/ML performance metrics, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies) because the document does not pertain to an AI/ML device study.
The closest information available is related to non-clinical performance testing for the physical safety and performance of a wheelchair, not an AI/ML algorithm.
§ 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).