(1155 days)
The Ki Mobility Power Tilt System kit design is intended for use on a manual wheelchair to provide patients with posterior tilt for positioning and seating pressure relief.
The Ki Power Tilt System is an assembly that can be used to provide powered tilt on a manual wheelchair. It is an option for the Focus CR manual wheelchair to allow user control of the seating tilt angle. The system uses a battery operated motor gear drive connected between the base frame and the rotational seat tilt frame. A curved gear rack is coupled to the rocker frame and driven by the motor gearbox to control tilt motion. The user controls tilt using a toggle switch or hand pendant control connected to the motor control box. Adaptive switches, such as head arrays, may be connected to an interface control box that connects to the control box. An external battery charger is provided to charge the system. The motor control system uses a soft start/soft stop for ramping down the motor speed with a current limit to momentarily shut down power supply to the motor. End of travel in the tilt range will engage the current limit and the Focus CR Tilt Stops can be used to limit the tilt range from the unrestricted range of 0° to 50°.
The provided text describes the regulatory clearance of a medical device, the Ki Mobility Power Tilt System, and its substantial equivalence to a predicate device. It outlines the device's design, intended use, and technological characteristics. However, the document does not contain the specific details required to answer your questions about acceptance criteria and a study proving device performance in the context of AI or algorithmic evaluation.
The "Performance Data" section discusses:
- Physical performance characteristics (tilt range, weight capacity) of the Ki Power Tilt System compared to the predicate.
- Biocompatibility testing (ISO 10993).
- Mechanical and safety testing against various ISO 7176 standards (wheelchair standards).
The document does not describe an AI/ML-driven device or study related to AI performance, algorithmic acceptance criteria, human reader improvement with AI, standalone algorithm performance, or how ground truth for an AI model would be established.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria and a study proving device performance in the context you've provided, as this information is not present in the given text.
If your request pertains to a different type of medical device (e.g., an AI-powered diagnostic tool), please provide the relevant text.
§ 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).