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The W5905 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 product is suitabled people with mobility difficulties and elderly people.

The subject Power Wheelchair is a wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk designed to be propelled by power from electric motors. The electronic control of speed and direction can be performed by the occupant with the help of controlling joystick. The device can be quickly folded and disassembled, which makes it convenient to be stored or placed at the trunk of vehicles while traveling.

The subject Power Wheelchair is intended to provide mobility to a disabled or elderly limited to a seated position. It is of indoor and outdoor type, suitable for the use indoor and flat path near buildings, but not on grass, gravel roads, large slopes or motorway, neither on muddy, rugged, soft, narrow, icy road, bad roads such as dangerous roads without guardrails or waterways.

The subject Power Wheelchair consists of two parts, the wheelchair main body and the electrical part. The main body includes a main foldable frame, two armrests, a seat cushion, a safety belt, two rear driving wheels and two front wheels. The electrical part is composed of two motors, two brakes, a li-ion battery, a controller and an off-board charger.

The device is powered by a Li-ion battery (24V 12Ah) with 15 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. The further the joystick is pushed from its central position, the faster the wheelchair moves, when it is released, it will automatically reset and brake.

The provided text describes the W5905 Power Wheelchair's equivalence to a predicate device (Y207 Electric Wheelchair) for FDA 510(k) clearance, not the detailed acceptance criteria and study proving its performance in a clinical or AI context. The document focuses on performance requirements according to international standards (ISO and IEC) for wheelchairs.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present "acceptance criteria" in a table format directly alongside "reported device performance" from a study. Instead, it refers to compliance with various ISO and IEC standards that define performance requirements for power wheelchairs. The "performance" described is the subject device meeting these standards.

Here's an attempt to extract relevant comparison points, which can be interpreted as the device meeting specific performance specifications relative to the predicate device and relevant standards:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes non-clinical testing performed on the device itself to comply with various ISO and IEC standards. These tests are typically performed on a sample of the manufactured device. However, the exact "sample size" (e.g., number of units tested) for each specific test is not explicitly mentioned in the provided text.

Data provenance (country of origin, retrospective/prospective) is not applicable in the context of these engineering and performance standard tests. The tests are focused on the physical device's characteristics and its ability to meet documented engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable. The product is a power wheelchair, and the evaluation is based on engineering and performance standards (e.g., braking distance, stability, battery life), not on human interpretation or diagnosis. Therefore, "ground truth" established by medical experts is not relevant to this type of device clearance. The "ground truth" is the objective measurement against the specified standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies where multiple human readers interpret data (e.g., medical images) and their disagreements need to be resolved. The evaluation here is based on objective, quantifiable engineering tests, not subjective interpretations.

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

This question is not applicable. The device is a power wheelchair, not an AI-powered diagnostic or assistive technology that involves human readers interpreting cases or data.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is not an algorithm or AI system. It's a physical medical device (a power wheelchair).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical tests is defined by the objective, measurable criteria stipulated in the international standards (e.g., ISO 7176 series, IEC 60601-1-2) themselves. For instance, the ground truth for "braking distance" is the actual distance measured under specified conditions, compared against the maximum allowed distance by the standard. For "biocompatibility," the ground truth is whether the materials, when tested, meet the criteria for non-toxicity, non-irritation, and non-sensitization as defined by ISO 10993 standards.

8. The sample size for the training set

This question is not applicable. This is not an AI or machine learning device that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable. The device does not utilize a training set or AI.

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