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The Manual Wheelchair is to provide mobility to persons limited to a sitting position.

The S002, S004, S005, S006, S007, S008, S009 series are mechanical wheelchairs which are a manually operated devices with wheels that are intended for medical purposes to provide mobility to persons restricted to a sitting position. It can be folded for transport by bring the two sides together. The manual wheelchair incorporates a main frame, a seat, two adjustable footrests and four wheels. The larger rear wheels have hand rims of slightly smaller diameter projecting just beyond the tire. These allows the user to manoeuvre the chair by pushing them on without requiring them to grasp the tires. The manual wheelchairs have brakes that bear on the tires of the rear wheels and two push handles at the upper rear of the frame to allow for manual propulsion by an assistant.

Main Components: Main frame, Backrest, Seat cushion, handgrip, front wheel, rear wheel, hand rim, crossbar, footrests, brake, Anti-tipper, Seat belt.

The device can be operated indoors, or outdoors on dry, level surfaces composed of concrete, blacktop, or asphalt under normal driving conditions.

This FDA 510(k) summary describes a Manual Wheelchair (Models: S002, S004, S005, S006, S007, S008, S009) and its substantial equivalence to a predicate device (K232230). The information provided is for a physical medical device, not an AI/software device. Therefore, many of the requested categories related to AI/software performance criteria (such as sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this document.

However, I can extract the acceptance criteria related to the physical device's performance and the study details that demonstrate it meets those criteria.

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not specified in the document. For physical device performance testing, samples are typically a representative number of units, but specific numbers are not usually detailed in a 510(k) summary unless a specific statistical power is claimed for a particular test.
• Data provenance: The tests were conducted by the applicant, Anhui JBH Medical Apparatus Co., Ltd, in China (No.116 QiCang Road Industrial District MingGuang Chuzhou,Anhui, China). The data is retrospective in the sense that the tests were performed on finished devices to demonstrate compliance.

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

This information is not applicable. For physical device performance, "ground truth" is established through standardized testing procedures and objective measurements as defined by the referenced ISO standards, not through expert consensus on interpretation.

4. Adjudication method for the test set:

Not applicable. Physical device performance is determined by meeting objective criteria defined in the ISO standards, not by an adjudication process as used in clinical or imaging studies.

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 a physical medical device, not an AI/software device.

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

Not applicable. This is a physical medical device, not an AI/software device.

7. The type of ground truth used:

The "ground truth" for the device's performance is established by its adherence to the technical specifications and performance limits defined within the cited international ISO standards (e.g., ISO 7176 series for wheelchairs and ISO 10993 series for biocompatibility). This is essentially objective measurement against predefined engineering and biocompatibility standards.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/software device that requires a training set.

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

Not applicable. This is a physical medical device, not an AI/software device.

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