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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 product consists of frame, wheels, seat, armrest, lithium battery, motor and controller with a lightweight and compact design. The whole wheelchair can be folded by one button and it can be easily carried or rolled after folding, The seat cushion is detachable. The armrest can be flipped backward, which is convenient for the wheelchair by the wheelchair by themselves through the control device.

The wheelchair uses lithium batteries as its power source. The drive left/right motor to realize the wheelchair forward, backward and turn functions.

The frame of the device is carbon fiber. The front wheels suitable for rotation, acceleration, retrograde and other actions of the wheelchair. The front wheels mover will be achieved by thrust generated from the rear wheels are driving wheels to control the speed and direction. The wheels are Solid PU tires.

When in use, the operator drives the motor of the rear wheel by operating the controller handle (joystick) to achieve the rear wheels movement.

The DC Brushless motor and Brake system are fixed on the rear wheels. The max loading of the device is 125KG. Only for one person sit.

This is an FDA 510(k) premarket notification for an Electrically Powered Wheelchair (K241632).

For devices like this (powered wheelchairs), the acceptance criteria and study that proves the device meets them typically involve demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical performance testing to relevant international standards. Unlike AI/ML-based medical devices, there isn't a "test set" in the sense of a dataset for algorithm evaluation, nor are there "expert readers" establishing ground truth in the same way. The "performance" refers to the physical and functional aspects of the wheelchair.

Here's a breakdown based on the provided document:

Acceptance Criteria and Reported Device Performance

The document states that the device's acceptance criteria are met by demonstrating compliance with various international ISO and IEC standards relevant to electrically powered wheelchairs. The reported "performance" is inherently tied to passing these standards.

Table 1: Acceptance Criteria and Reported Device Performance

The document explicitly states: "The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device K231508."

Study Details

Given the nature of the device (electrically powered wheelchair) and the information provided in the 510(k) summary, the "study" is a series of non-clinical, bench-top, and possibly simulated-use tests to demonstrate compliance with the referenced international standards.

1. Sample size used for the test set and the data provenance:

   • Sample Size: The document does not specify a numerical sample size (e.g., number of wheelchairs tested). For non-clinical performance testing of physical devices, testing typically involves a representative sample or a single unit (depending on the test standard and design).
   • Data Provenance: The document does not explicitly state the country of origin for the testing data itself. The applicant is Kunshan Hi-Fortune Health Products Co., Ltd in China, and their consultant is in Shanghai, China. It is highly probable that the testing was conducted in laboratories in China, often by accredited testing houses. The testing would be considered prospective in the sense that it was conducted specifically to demonstrate compliance for this 510(k) submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this device and 510(k) submission. "Ground truth" established by experts (like radiologists for AI algorithms) is not a component of demonstrating substantial equivalence for an electrically powered wheelchair. The "ground truth" here is the pass/fail criteria defined by the requirements of the international standards themselves. Compliance is verified by engineers and technicians performing the tests according to standard protocols.

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

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on image interpretation or clinical outcomes, typically in studies involving human readers or clinical trials. For non-clinical performance testing against engineering standards, compliance is objectively measured.

4. 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. MRMC studies are used to evaluate AI-assisted diagnostic devices in a clinical reading setting. This 510(k) is for a powered wheelchair, not a diagnostic device.

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

   • This refers to AI algorithm performance. This is not applicable as this is not an AI/ML device. The "standalone performance" refers to the physical functionality of the wheelchair according to the specified standards.

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

   • The "ground truth" for this device's performance is objective compliance with the pass/fail criteria and specifications outlined in the referenced international standards (e.g., maximum speed, turning radius, battery performance, mechanical strength, electromagnetic compatibility limits, flammability). It is a standards-based performance evaluation, not clinical outcomes or expert interpretation.

7. The sample size for the training set:

   • This is not applicable. There is no "training set" in the context of a physical device like a powered wheelchair unless it uses an AI/ML component (which is not described or implied here). The design and engineering of the wheelchair are based on established principles, not a data training set.

8. How the ground truth for the training set was established:

   • This is not applicable for the same reasons as above.

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