Search Results

The Mechanical Wheelchairs are intended to provide mobility to persons restricted to a sitting position.

Not Found

The provided document is a 510(k) clearance letter from the FDA for several models of mechanical wheelchairs. It establishes substantial equivalence to legally marketed predicate devices.

This document DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.

The 510(k) process for these types of Class I mechanical devices typically relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This often involves engineering bench testing to ensure structural integrity, maneuverability, and other physical properties meet established standards for wheelchairs, rather than clinical studies with human participants or AI/ML algorithm evaluations.

Therefore, I cannot answer your specific questions as they pertain to AI/ML device evaluations, as the provided document is not about such a device. An AI/ML device submission would typically include a detailed clinical study report or performance testing report which outlines the information you are requesting.

Ask a specific question about this device