(101 days)
The Electric wheelchair is a motor driven, indoor and outdoor transportation vehicle with the intended use to provide mobility to a disabled or elderly person limited to a seated position.
Electric wheelchair
This document is an FDA 510(k) clearance letter for an electric wheelchair. It does not contain information about acceptance criteria or a study proving that a device (medical or otherwise) meets specific performance criteria through a study involving AI or human readers, ground truth, or sample sizes.
The information you are asking for (acceptance criteria, study details, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in documentation for AI/ML-enabled medical devices, often in their 510(k) summary, clinical study reports, or specific performance reports submitted to the FDA.
Since the provided text is solely an FDA clearance letter for a physical medical device (an electric wheelchair) and not a software/AI-driven diagnostic or therapeutic device, it does not describe the kind of performance study you are asking about.
Therefore, I cannot fulfill your request based on the provided text. The document is about the regulatory clearance process for an electric wheelchair, not its performance validation through a study as described in your prompt.
§ 890.3860 Powered wheelchair.
(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).