(51 days)
The device is intended for medical purposes to provide mobility to persons restricted to a seated position.
The SINON SN-L402 Foldable Wheelchair is an 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.
The provided text describes a 510(k) premarket notification for a medical device (SINON SN-L402 Lightweight Wheelchair). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria based on specific performance metrics or clinical outcomes.
Therefore, many of the requested categories in the prompt (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable because the document does not present a clinical or performance study of the type that would involve these elements.
Here's the information that can be extracted from the provided text based on your prompt:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards. | SINON SN-L402 Lightweight Wheelchair meets the applicable performance requirements as specified in ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards. |
| Intended use: provide mobility to persons restricted to a seated position. | SINON SN-L402 Lightweight Wheelchair is intended for medical purposes to provide mobility to persons restricted to a seated position. |
| Weight limit: 100 kgs. | The weight limit is 100 kgs. |
| Foldable mainframe. | The mainframe is foldable. |
| Back upholstery material: resistance-ignitability fabric (meeting California Technical Bulletin CAL 117 standard for flame retardant). | The back upholstery material is resistance-ignitability fabric and meets the California Technical Bulletin CAL 117 standard for flame retardant. |
2. Sample size used for the test set and the data provenance
- Not applicable / Not provided. The document states that the device "meets the applicable performance requirements" of standards but does not detail a specific test set or clinical study with patient samples. The testing appears to be primarily engineering/product performance testing against established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. Ground truth, in the context of clinical studies, is not referenced as this is a device performance and substantial equivalence submission.
4. Adjudication method for the test set
- Not applicable / Not provided.
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 device is a mechanical wheelchair, not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a mechanical wheelchair, not an algorithm.
7. The type of ground truth used
- For product performance: Compliance with ANSI/RESNA WC Vol. 1 and ISO 7176 Wheelchair Standards served as the basis for evaluating performance. In mechanical testing, the "ground truth" is often defined by the pass/fail criteria set forth by these recognized industry standards.
- For substantial equivalence: The predicate device (BIOTECH B900 SUPER LIGHT Wheelchair, K020472) served as the basis for comparison.
8. The sample size for the training set
- Not applicable / Not provided. No "training set" in the context of an algorithm or machine learning is mentioned.
9. How the ground truth for the training set was established
- Not applicable / Not provided.
§ 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).