(81 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The KAIYANG Aluminum Wheelchair is indoor / outdoor wheelchair that has a base with four-wheeled with a seat. The device can be disassembled for transport and it is foldable easily. The device uses a standard sling type back and seat, the upholstery fabric meets the California Technical Bulletin CAL 117 standard for flame retardant.
This looks like a 510(k) summary for a medical device (a wheelchair), not an AI/ML device. Therefore, the requested information about acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment is not applicable to this document.
The document describes the KAIYANG Aluminum Wheelchair and its intended use. Here's what can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from recognized standards) | Reported Device Performance |
|---|---|
| ANSI/RESNA WC vol. 1 Wheelchair Standards | Meets requirements |
| ISO 7176 Wheelchair Standards | Meets requirements |
| California Technical Bulletin CAL 117 standard for flame retardant | Meets standard |
2. Sample size used for the test set and the data provenance
Not applicable. This is a physical non-AI/ML device. Testing refers to product performance testing against standards, not data-driven evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth and expert adjudication are concepts used in AI/ML model evaluation, not for mechanical device testing. The "truth" here is compliance with engineering standards.
4. Adjudication method for the test set
Not applicable.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
Not applicable in the context of AI/ML. For this mechanical device, the "ground truth" or reference for evaluating performance would be the specifications and test methods defined within the ANSI/RESNA WC vol. 1, ISO 7176, and CAL 117 standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary based on the provided text:
The KAIYANG Aluminum Wheelchair underwent performance testing to demonstrate compliance with established international and state-specific standards for wheelchairs. The manufacturer states that the device "meets the applicable performance requirements as specified in ANSI/RESNA WC vol. 1 and ISO 7176 Wheelchair Standards." Additionally, the upholstery fabric "meets the California Technical Bulletin CAL 117 standard for flame retardant."
The submission primarily relies on substantial equivalence to a predicate device, the JAN MAO Wheelchair JMC612-FL318EPP & JMC612-FL418EPP (K062218), rather than a clinical study or AI/ML performance evaluation. The comparison highlights similarities in intended use, foldable design, removable armrests, detachable footrests, and flame-retardant back upholstery material. The overall conclusion is that "the new device is substantially equivalent to the predicate device."
§ 890.3850 Mechanical wheelchair.
(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).