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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.

whole wheelchair can be folded by one button and it can be easily carried or rolled after folding type:left-right folding). The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the elderly to move. Users can drive the wheelchair by themselves through the control device.

The wheelchair uses lithium batteries as its power source. The crive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels movement will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are solid polyurethane tires.

When in use, the operator drives the motor of the rear wheel by operating the rear wheels movement. The DC brushless motor and brake system are fixed on the rear wheels.

The max loading of the device is 136KG. Only for one person sit.

I am sorry, but the provided text is a 510(k) summary for a "Power wheelchair (N6101)" and does not contain information about acceptance criteria or specific studies relevant to AI/ML device performance. It mainly focuses on demonstrating substantial equivalence to a predicate device through adherence to various ISO standards and non-clinical testing.

Therefore, I cannot extract the requested information regarding:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on compliance with standards rather than specific performance metrics and their acceptance thresholds.
2. Sample size used for the test set and the data provenance: Not applicable as no AI/ML test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document discusses non-clinical tests to demonstrate safety, but these are related to physical and electrical aspects of the wheelchair (e.g., ISO 7176 series for wheelchairs, IEC 60601 for medical electrical equipment), not AI/ML performance. It explicitly states "Clinical test summary is not applicable." and focuses on "technological characteristics, features, materials, mode of operation" and "biocompatibility tests."

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