(86 days)
The intended use of the C350 powered wheelchair is to provide outdoor and indoor mobility to persons limited to a seated position that are capable of operating a powered wheelchair.
C350 Powered Wheelchair is battery powered, rear wheel motor driven and is controlled by the PG power wheelchair VR-2 70 amp controller. The user interface is a joystick. The C350 is powered by two 12VDC 60Ah, Group M34 batteries, approximate driving range on fully charged batteries is up to 22 km (13.75 miles), depending on use and the terrain the chair is driven on. The chair frame is a rived nut and welded steel construction and includes two rear drive wheels with drive units (motor, gear, brake), batteries and front pivoting casters. Depending on users needs, the joystick motor control is mounted to the left or right armrest. When the user activates the joystick, the controller receives a signal to release the brakes. With the brakes released, the chair is allowed to move in the direction the joystick is actuated. When the user releases the joystick, the chair slows to a stop and the brakes are automatically re-engaged. The solenoid electromechanical brakes allow the user stop by letting go of the joystick.
The provided document, K071650 for the Permobil Powered Wheelchair: C350, does not contain information typically found in studies for AI/ML-driven medical devices. This is a premarket notification for a physical medical device (a powered wheelchair) from 2007, which predates the widespread acceptance and integration of AI/ML into medical device regulations.
Therefore, the requested information regarding acceptance criteria and studies for an AI device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, is not present in this document.
The "Performance Data" section merely states: "In all instances, the C350 functioned as intended." This indicates a fundamental functional performance assessment rather than a study with statistical metrics. The substantial equivalence argument relies on comparing the C350 to its predicate device, the C300 (K041219), and asserting that "The minor technological differences between the Electro and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the C350 is as safe and effective as the C300(Electro)."
Since the document pertains to a traditional physical medical device and not an AI/ML-driven one, I cannot extract the requested information as it is not applicable to the content provided.
§ 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).