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It 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.

This Electric Wheelchair, models: Panda 10 and Panda 12, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped people and disabled people to move. It is suitable for disabled people with mobility difficulties and elderly people.

The device consists of front wheel, drive wheel, frame, controller, motor, armrest, backrest, seat cushion, pedal, battery box and charger.

The device is powered by Li-ion Battery pack with 9.7 Km range, which can be recharged by an off- board battery charger that can be plugged into an AC socket outlet (100-240V, 50/60Hz) when the device is not in use.

The patient can activate the controller handle (joystick) to control the speed and direction of the wheelchair movement. In addition, when the patient releases the joystick, the joystick will return back to the central position and the wheelchair will be automatically stopped soon due to automatic electromagnetic brake system. Once the joystick is activated again move to other position, the wheelchair will be re-energized.

This document is a 510(k) premarket notification for an electric wheelchair. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria for AI performance. Therefore, the information requested in the prompt regarding AI-related studies and acceptance criteria is not present in this document.

Specifically, the document includes:

• Non-Clinical Test Conclusion (Section F): This section lists various ISO standards that the device complies with, such as ISO 10993 (biocompatibility) and ISO 7176 (wheelchair-specific performance like stability, braking, speed, etc.). These are engineering and safety standards, not performance criteria for an AI-powered system.
• Clinical Test Conclusion (Section G): Explicitly states, "No clinical study is included in this submission." This confirms the absence of human subject trials or performance evaluations that would typically feature AI-related acceptance criteria.
• Comparison with Predicate Device (Section H): This table compares the subject device and the predicate device across various physical and functional parameters, demonstrating similarity. There is no mention of AI functionality in either device.
• Table 2 and Table 3 Safety Comparison: These tables reiterate compliance with various ISO standards for safety and performance, again not related to AI.

Given the content, I cannot provide the requested information about AI acceptance criteria and study details because the device described is an electric wheelchair, and the submission focuses on its mechanical, electrical, and safety performance in comparison to a predicate device, not on AI-driven capabilities.

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