(77 days)
LANDLEX 402x scooter is intended for an indoor/outdoor scooter that provides transportation for disabled or elderly persons limited to a seated position
The LANDLEX 402x scooter is an indoor/outdoor transportation vehicles which is battery operated The movement of the scooter is controlled by a tiller handle and a thumb operated potentiometer throttle control lever to engage and disengage the scooter motion in both the forward and reverse directions
I am sorry, but based on the provided document, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them.
The document is a 510(k) summary for the LANDLEX 402x scooter, which is a regulatory submission to the FDA. It declares the device's "substantial equivalence" to predicate devices, meaning it claims that it is as safe and effective as existing legally marketed devices.
However, a 510(k) summary does not typically include detailed information about specific acceptance criteria or the studies that demonstrate device performance against those criteria. It focuses on demonstrating equivalence to predicate devices, often by comparing performance specifications (as mentioned in the document "There are minor differences in performance specifications of the scooters, these differences do not alter the intended function and use of the device..."), rather than providing a rigorous independent study with specific acceptance metrics.
Therefore, the requested information, such as a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details, is not present in this document.
§ 890.3800 Motorized three-wheeled vehicle.
(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).