Search Results

The Titan 3W is a mobility assistive device for indoor and outdoor use on mild terrain. It is not used as a transportation vehicle on roads and freeways used by cars.

The Titan 3W scooter is an electrically powered scooter. It is intended to be used by individuals that are able to walk, but suffer from mobility limitations. The user must have sufficient arm and leg strength to get on and off the Titan 3W alone and to safely steer under all driving conditions. The Titan 3W is intended for indoor use and outdoor use. The Titan 3W has reflectors and lights, which should be used in the dark or in limited visibility conditions. The Titan 3W can be folded and disassembled into two parts, the Front Frame and the Rear Frame. Separating both frame parts allows for easy storage and enables portability of the Titan 3W. The Front Frame consists of the steering column, control panel, front wheels, footrest plate and seat. The Rear Frame consists of the motor, controller and battery holders. The control panel houses all the controls for operating the device. The control panel has a key switch for turning the device on and off. a lever for forward/reverse driving, knobs and switches for speed adjustment and lights (front and rear lights, indicators and hazard lights). The control panel also contains the control indicator for the status of the device and a battery gauge. The LED control indicator shows the status of the scooter: steady light mean that all is well, blinking indicates an issue. The number of flashes indicate the type of issue. The User Manual contains a troubleshooting section where each type of error and its solution is specified. The steering column can be adjusted and put it in the position which is most comfortable for the operator.

The provided text describes the 510(k) premarket notification for the Titan 3W, a motorized three-wheeled vehicle. It details a comparison to a predicate device, the Titan 4W, and provides performance test results against various ISO standards. However, it does not contain information related to an AI/algorithm-based device, human reader studies, or the specific criteria and study details as requested for an AI/algorithm's acceptance criteria and performance.

Therefore, I cannot fulfill the request to provide the acceptance criteria and study that proves the device meets them in the context of an AI/algorithm, human readers, or ground truth. The document is about a physical medical device (mobility scooter) and its substantial equivalence to a predicate device based on engineering and safety standards.

Ask a specific question about this device