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The Power Wheelchair 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 Power wheelchair 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, push-handle, backrest, seat cushion, pedal, battery box and charger. The device is powered by 2 Li-ion Battery pack (24V 10Ah, 240Wh) with 20 Km (12.5 miles) 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.

The provided text describes the regulatory clearance for a Power Wheelchair, W5907, not an AI/ML powered medical device. Therefore, the information requested about acceptance criteria and studies related to AI/ML device performance (such as sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or present in the document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (K113463) through non-clinical performance and biocompatibility testing, adhering to various ISO standards relevant to wheelchairs.

However, I can extract and present the performance criteria and reported performance based on the non-clinical testing described for the Power Wheelchair, W5907 as an analogy to acceptance criteria.

Acceptance Criteria and Reported Device Performance (Non-AI/ML Device)

Since this document describes a power wheelchair and not an AI/ML device, the typical acceptance criteria for AI/ML performance metrics (like sensitivity, specificity, AUC) are not applicable. Instead, the "acceptance criteria" here are defined by compliance with established international standards for wheelchairs. The reported device performance is implicitly that the device met these standards.

1. Table of Acceptance Criteria and the Reported Device Performance

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" in this context refers to the physical device undergoing non-clinical bench testing according to international standards (e.g., ISO, IEC). The data provenance is from laboratory testing of the manufactured device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI/ML device requiring expert ground truth for interpretation. Compliance with standards is typically assessed by qualified testing engineers/laboratories.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no human interpretation or adjudication of AI/ML output is involved.

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/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For this physical device, "ground truth" is defined by the objective pass/fail criteria specified within each referenced ISO and IEC standard.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

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

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