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K Number
K040818
Device Name
MEDLINE STRIDER MINI 3
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2004-05-07

(38 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The intended use of the Medline Strider MINI 3 scooter is to provide mobility to persons that have difficulty walking for prolonged periods of time. They are intended to increase the mobility of persons who are both physically and mentally capable of assessing and reacting to any driving situation.

The Medline Strider MIN1 3 scooter is constructed for use both indoors and outdoors. They are for use indoors, on pavement, sidewalks, pedestrian zones and areas free from motor traffic. They must not be driven on public roads with the exception of crossing or when no pavements are available.

Device Description

Not Found

AI/ML Overview

The provided documents are a 510(k) clearance letter from the FDA for a medical device called the "Medline Strider MINI 3," which is a motorized three-wheeled vehicle. This type of document is typically for demonstrating substantial equivalence to a predicate device and does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria in the way a clinical trial or performance study for AI/software-as-a-medical-device (SaMD) would.

Therefore, none of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) can be extracted from these documents.

These documents primarily confirm:

  • The device name: Medline Strider MINI 3
  • Its classification: Motorized three-wheeled vehicle, Class II, Product Code: INI
  • Its intended use: To provide mobility to persons with difficulty walking for prolonged periods, who are physically and mentally capable of assessing and reacting to driving situations. For both indoor and outdoor use (pavement, sidewalks, pedestrian zones, areas free from motor traffic, with specific exceptions for public roads).
  • The FDA's determination of substantial equivalence to a legally marketed predicate device, allowing it to be marketed.

This 510(k) clearance is a regulatory step, not a performance study report for AI-driven devices.

§ 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).