(69 days)
In order to transport patient(s) and/or disable people This particular wheel chair is manual,not electrical device. It is highly recommended that someone(nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concerete road,pavement sudd floor for the safety and effectiveness.
WHEEL CHAIR(MANUAL,NOT ELECTRICAL)
The provided text is an FDA 510(k) clearance letter for a manual wheelchair, not a study report for an AI/ML medical device. Therefore, it does not contain any of the requested information regarding acceptance criteria or a study proving device performance for an AI-based system.
The document describes a manual wheelchair (not electrical) and states that its intended use is to "transport patient(s) and/or disable people." It specifies that "someone (nurse, assistant, nursing home staff or family member) operates this device to transport patient(s) and/or disable people on even surface like concrete road, pavement, sudd floor for the safety and effectiveness."
Since this is a clearance for a simple mechanical device, the concepts of acceptance criteria for an AI model, sample sizes for training/test sets, ground truth establishment, expert adjudication, or MRMC studies are not applicable to the information contained in these documents.
§ 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).