(175 days)
The "Electric Wheelchair, Model: KR8803" 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 Electric Wheelchair (Model: KR8803) is a motor-driven, and indoor/outdoor electric transportation vehicle that is intended to be used by individuals that are disabled or elderly for short distance travel. It has a base with Aluminum alloy frame, two front wheels, two rear wheels, two anti-tippers, two arm rests, one seat, one backrest frame with push handle, two brushed DC motor. One driver and one controller, one lower leg support assemblies, one foot support, electromagnetic braking system, steering mechanisms and one rechargeable Li-ion battery with an off-board charger. The movement of the wheelchair is controlled by the occupant or assistant who operates the controller (joystick). The device is installed with an electromagnetic brake that will engage automatically when the wheelchair is not in use and the brake cannot be used manually. The device only can be operated on the flat road.
The Electric Wheelchair has a physical dimension of 105 (depth) x 60 (width) x 99 (height) cm. with the seat itself has a dimension of 44.5 (depth) x 45 (width) x 42 (height) cm. The footrest is 9.5 cm in height. The device is foldable, and the folded dimension is 60 (Long) x 39.5 (width) x 80 (height) cm.
The Electric Wheelchair has a maximum weight capacity of 120 kilograms, and weighs about 26.68 kilograms with battery (23.5 kilograms without battery). The color is black.
The Electric Wheelchair consists of four wheels, a mechanical main frame, seat, backrest frame with push handle, and mesh fabric upholstery that is ignition resistant.
The frame of the device is made of aluminum alloy.
The Electric Wheelchair uses aluminum alloy wheels and the back wheel has a diameter of 25.4 cm (12 inch) and the front wheel has a diameter of 20.3 cm (8 inch). Both front wheels use solid tires and the back wheels are pneumatic tires.
The Electric Wheelchair has a motor of 24V and 250 Watt, which allows a maximum speed of 5.2 kilometers per hour, and maximum travel range of 20 kilometers. The wheel lock is in the form of electromagnetic force to apply mechanical resistance to the rear wheels to force stop.
The provided text describes a 510(k) summary for an Electric Wheelchair (KR8803) and its comparison to a predicate device. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/human reader performance study.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing against established standards for wheelchairs. There is no mention of an algorithm or AI assistance, nor any human reader performance evaluation.
Therefore, the requested information regarding acceptance criteria, reported device performance in the context of AI/human reader studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for such studies is not available in the provided text.
The text does state in section 8.0: "Clinical study is not performed for this product," which further confirms the absence of any studies involving human subjects or the evaluation of diagnostic performance.
§ 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).