(25 days)
The Icon Adult Manual Wheelchair is a mechanical wheelchair intended to provide mobility to persons with disabilities restricted to a seated position.
The Icon Adult Manual Wheelchair is a rigid manual wheelchair, with a centralized modular design. The frame components of the chair are aluminum.
The provided text is a 510(k) summary for a manual wheelchair, not a medical device driven by an algorithm or AI. Therefore, it does not contain the information required to answer your specific questions related to AI-driven device acceptance criteria and study design.
However, I can extract the acceptance criteria and performance information that is present in the document for this physical device.
1. A table of acceptance criteria and the reported device performance
For the Icon Adult Manual Wheelchair, the "acceptance criteria" are implied by the standards it references, and the reported performance is simply that the results were "as expected" with "no pass/fail criteria" explicitly stated in the summary.
| Characteristic | Standard/Test/FDA Guidance | Reported Device Performance |
|---|---|---|
| Static Stability | ANSI/RESNA WC/Volume 1-1998, Section 1: Determination of Static Stability | Results were as expected |
| Overall dimensions, mass and manoeuvring space | ANSI/RESNA WC/Volume 1-1998, Section 5: Determination of overall dimensions, mass and manoeuvring space | Results were as expected |
| Static, Impact & Fatigue Strength | ANSI/RESNA WC/Volume 1-1998, Section 8: Requirements and Test Methods for Static, Impact and Fatigue Strengths | Results were as expected |
| Resistance to Ignition | ANSI/RESNA WC/Volume 1-1998, Section 16: Resistance to Ignition of Upholstered Parts | Results were as expected |
Regarding the other questions (2-9), these are specifically geared towards AI/algorithmic devices and are not applicable to the Icon Adult Manual Wheelchair, which is a physical mechanical device.
The document states:
- "There is no pass/fail criteria for this test – results were as expected."
- The tests are "SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE". These tests are designed to show that the new device performs similarly to a predicate device based on established standards for mechanical wheelchairs, rather than meeting specific performance metrics derived from a data-driven model.
- The device is a "mechanical wheelchair," not an AI product.
§ 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).