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The YH-E7007 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 suitable for disabled people with mobility difficulties and elderly people.

The subject device, Power Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed.

The power wheelchair is a battery powered four wheeled vehicle. It consists Li-ion battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel(including: Battery indicate, ON/OFF button, Horn, Gear indicator, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.

The operation of the scooter: Use the On/Off button to turn on or turn off the power, The main function of the Joystick is to control the speed and direction of the wheelchair, the Joystick can control the wheelchair to travel in any direction, the operation of the Joystick movement will determine the wheelchair in that direction speed of movement. The farther the Joystick is moving from the center, the faster the wheelchair runs. When you release the Joystick, the wheelchair is automatically braked. Use the speed control button to reduce or increase the speed setting. The Electric/ manual model change lever underneath the seat will allow for the brakes to engage or disengage. When adjusted to the manual model, the assistant can easily push the wheelchair. The power wheelchair has a structure for quick assembly and disassembly that is convenient to be stored or placed in the trunk of your vehicle while traveling.

The Power Wheelchair has 8 inch front wheel and 12 inch rear tire.

The motor of power wheelchair is DC24V 250W; the battery is 24V 12AH, Li-ion battery; the charger is 24V/2A.

Max. loading can not be over than 120Kgs.

Max. distance of travel on the fully charged battery is 20km and Max. speed forward is 6km/h.

The braking time is about 2s, and the braking distance is ≤1.5m.

The provided text describes the 510(k) premarket notification for the Ningbo Youhuan Automation Technology Co., Ltd. Power Wheelchair (YH-E7007). It details the device's characteristics and compares it to a predicate device, but it does not include information about acceptance criteria and a study proving that the device meets these criteria in the context of an AI/ML-driven device.

This document is for a Power Wheelchair, which is a physical device, and the evaluation for substantial equivalence primarily relies on non-clinical performance testing against established ISO standards and a comparison of technical specifications with a legally marketed predicate device.

Therefore, many of the requested points regarding AI/ML device evaluation are not applicable to this submission. I will address the relevant sections based on the provided text, and explicitly state when information is not available or not applicable.

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

The acceptance criteria for this medical device are primarily established by compliance with a comprehensive set of ISO standards for wheelchairs and related components, as well as biocompatibility assessments. The "reported device performance" is demonstrated by the results of non-clinical tests showing compliance with these standards and a comparison of specifications with the predicate device.

Table 1: Acceptance Criteria (as indicated by compliance with standards) and Reported Device Performance

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

This information is not applicable in the context of an AI/ML test set as this is a physical device submission. The "test set" for this device consists of the physical device undergoing non-clinical performance and safety testing according to ISO standards. The text does not specify the number of units tested, but it states that "Non-clinical tests were conducted to verify that the proposed device met all design specifications." These tests are typically conducted in a laboratory setting.

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 is not applicable as this is not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment. The ground truth for performance is defined by established international engineering standards (ISO, IEC).

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

This is not applicable as this is not an AI/ML diagnostic device requiring human adjudication. Compliance with engineering standards is determined by test results vs. predefined thresholds.

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 is not applicable as this is a physical medical device (power wheelchair), not an AI/ML diagnostic or assistive technology that would involve human readers or MRMC studies. No such study was performed or is relevant for this device.

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

This is not applicable for a power wheelchair. While the device has software, it does not operate as a "standalone algorithm" in the diagnostic or analytical sense. Its software controls the physical operation of the wheelchair.

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

The "ground truth" for the device's performance and safety is defined by international engineering standards (ISO and IEC). These standards specify test methods and acceptable performance limits (e.g., stability angles, braking distances, speed, electromagnetic compatibility). For biocompatibility, the ground truth refers to established guidelines and tests (e.g., ISO 10993 series) to confirm material safety.

8. The sample size for the training set

This is not applicable as this is a physical device. There is no "training set" in the AI/ML sense for this product.

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

This is not applicable for the same reasons as point 8.

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