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The intended use of the Medline Strider MIDI 4 scooter is to provide mobility to persons that have difficulty walking for short periods of time. It is intended to be used by persons who are mentally capable of assessing and reacting to any driving situation. The Medline Strider MIDI 4 scooter is constructed for use both indoors and outdoors. It is for use indoors, on pavements, sidewalks, pedestrian zones and areas free from motor traffic. It must not be driven on public roads with the exception of crossing or when no pavements are available.

Medline Strider MIDI 4 scooter

This document is a 510(k) clearance letter from the FDA for a medical device called the "Medline Strider MIDI 4". This device is a motorized three-wheeled vehicle (scooter) and is classified as a Class II device.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically found in submissions for devices that employ AI or rely on performance metrics like sensitivity, specificity, or AUC.

Instead, this document is a regulatory clearance based on the device being "substantially equivalent" to a legally marketed predicate device. This means the FDA has determined that the new device is as safe and effective as a similar device already on the market, usually without requiring new clinical performance studies that define and test against specific numerical acceptance criteria.

Therefore, I cannot fulfill your request for the detailed breakdown of acceptance criteria and study information because it is not present in the provided document. The 510(k) process for this type of device (a mobility scooter) typically focuses on engineering specifications, safety features, and comparison to an existing similar product rather than the kind of AI/algorithm performance metrics you've asked for.

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