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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, model: YFWB-63, is a motor driven, indoor and outdoor transportation vehicle, which a device for assisting action handicapped 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, seatbelt, pedal, battery box and charger.

The device is powered by Li-ion Battery pack with 25 Km range, which can be recharged by an offboard 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.

The provided FDA 510(k) clearance letter and summary for the "Electric Wheelchair (YFWB-63)" detail a non-clinical study to demonstrate substantial equivalence to a predicate device, rather than a study proving the device meets acceptance criteria for an AI/Software as a Medical Device (SaMD).

Therefore, I cannot provide information on acceptance criteria and study details related to AI/SaMD, such as sample size for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or training set details. This document focuses on the mechanical and electrical safety and performance of a physical device (electric wheelchair) as per relevant ISO standards.

However, I can extract the acceptance criteria and reported device performance from the provided document as they pertain to the Electric Wheelchair (YFWB-63) and its comparison to the predicate device.

Acceptance Criteria and Reported Device Performance for Electric Wheelchair (YFWB-63)

The study conducted was a non-clinical test to verify that the proposed device met design specifications and was substantially equivalent (SE) to the predicate device (K220747). The acceptance criteria were primarily based on compliance with various ISO 7176 series standards related to wheelchairs and ISO 10993 series for biocompatibility.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of a dataset for software evaluation. Instead, it refers to physical testing of the device itself. The tests were conducted according to various ISO standards. The data provenance would be the test reports generated from these physical tests of the Electric Wheelchair (YFWB-63) device. No information on country of origin of the data or retrospective/prospective status as it pertains to a dataset is applicable here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the non-clinical testing of a physical medical device like an electric wheelchair. "Ground truth" in this context refers to established engineering standards (like ISO 7176) and directly measured physical performance, not expert consensus on medical images or patient outcomes. The testing would be performed by qualified engineers at a testing facility.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically associated with human-in-the-loop medical image review or similar subjective evaluations requiring multiple experts.

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. This is not an AI/SaMD device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/SaMD device. No algorithm is being evaluated in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this submission are the performance requirements and test methods defined by the referenced International Standards (ISO 7176 series, ISO 10993 series, etc.). The device's physical performance (e.g., speed, stability, braking distance, biocompatibility) was measured and compared against these objective, established standards.

8. The sample size for the training set
Not applicable. This is not an AI/SaMD device. There is no training set for a machine learning model.

9. How the ground truth for the training set was established
Not applicable. This is not an AI/SaMD device.

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