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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.

The subject device, Electric Wheelchair, mainly powered by battery, motivated by DC motor, driven by user controlling joystick controller and adjusting speed. Products for adult use.

The Electric Wheelchair is a battery powered four wheeled vehicle. It consists lead-acid battery with an off-board battery charger, Push handle, Seat, Back support, Joystick controller, Control panel (including: Speed light, ON/OFF button, Horn, Joystick, Accelerated button, Deceleration button), Arm supports, Anti-tip wheel, Front wheel, Rear wheels.

The operation of the Controller: 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 Electric 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 Electric Wheelchair has 7 inch front wheel and 12 inch rear tire.

Max. distance of travel on the fully charged battery is 13.3 km and Max. speed forward is 5.76 km/h.

When the wheelchair needs to stop, release the joystick. After a set period of time, the controller disconnects the solenoid brake power supply, and the internal spring squeezes the suction plate and friction plate to lock the motor, so as to brake.

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

The provided FDA 510(k) clearance letter and summary are for an Electric Wheelchair (HG-630). This document specifies performance criteria based on engineering and safety standards (ISO 7176 series), not on AI/algorithm performance. Therefore, the questions related to AI/algorithm performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, and standalone performance, are not applicable to this device.

The study proves the device meets acceptance criteria through a comparison to a predicate device and adherence to established international standards for wheelchairs.

Here's a breakdown of the acceptance criteria and proof of performance based on the provided text:

Acceptance Criteria and Device Performance for the Electric Wheelchair (HG-630)

The acceptance criteria for the Electric Wheelchair (HG-630) are primarily based on demonstrating substantial equivalence to a legally marketed predicate device (K240913) and compliance with relevant international performance and safety standards, specifically the ISO 7176 series and ISO 10993 series. The "performance" of the device is assessed against a set of engineering and safety specifications that ensure it functions safely and effectively as a powered wheelchair.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the adherence to a comprehensive set of ISO standards for wheelchairs and by demonstrating that the device's technical specifications are comparable to or meet the safety requirements outlined by the predicate device and those standards.

2. Sample Sizes Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a "test set" in the context of a dataset for AI/algorithm validation, as this is an electro-mechanical device. The performance is based on physical testing of the device itself.
• Data Provenance: The tests are conducted according to international standards (ISO series) which specify the methodologies. The manufacturer is Zhejiang Automwheel Tech Co., Ltd. from China. The testing would have been conducted in a laboratory environment, likely by the manufacturer or a third-party testing facility, to certify compliance with the stated ISO standards. This is akin to prospective testing on a manufactured unit.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Not Applicable. For an electric wheelchair, "ground truth" is established by adherence to engineering performance metrics and safety standards defined by organizations like ISO. There are no human "experts" establishing subjective "ground truth" in the way one would for diagnostic AI. The performance metrics are objective and measurable (e.g., braking distance, stability angles, dimensions).

4. Adjudication Method for the Test Set

• Not Applicable. As objective engineering parameters and safety standards are being met, there is no need for adjudication in the context of multiple human interpretations as there would be in, for example, medical image analysis. The tests either pass or fail the defined criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Not Applicable. This is not an AI/algorithm-assisted diagnostic device. Therefore, a comparative effectiveness study involving human readers' improvement with or without AI assistance is irrelevant.

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

• Not Applicable. This device is an electro-mechanical product. It does not have a "standalone algorithm" in the typical sense of AI/ML. Its performance is inherent to its design and functionality, which is then tested against industry standards.

7. The Type of Ground Truth Used

• Engineering and Safety Standard Compliance: The "ground truth" for this device's performance relies on objective, measurable physical parameters and functionalities as defined by established international standards (ISO 7176 series for performance, ISO 10993 series for biocompatibility, etc.). These standards set the benchmarks for what constitutes safe and effective operation for a powered wheelchair.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires machine learning training data.

9. How the Ground Truth for the Training Set was Established

• Not Applicable. No training set for AI/ML was used. The "ground truth" (i.e., compliance with performance and safety standards) is established through established test procedures defined by the ISO standards themselves.

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