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K Number
K072630
Device Name
FORU, MODEL EQ30
Manufacturer
KWANG YANG MOTOR CO., LTD.
Date Cleared
2007-10-03

(15 days)

Product Code
INI,89I
Regulation Number
890.3800
Type
Traditional
Panel
PM
Reference & Predicate Devices
K051538
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The ForU EQ30 scooter is motor driven, indoor transportation vehicles with the intended use to provide mobility to disabled or elderly persons limited to a seated position.

Device Description

The ForU EQ30 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.

AI/ML Overview

This document is a 510(k) premarket notification for a motorized scooter (ForU EQ30 scooter) and does not describe a clinical study or evaluation of an AI/ML device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details, ground truth establishment, or multi-reader multi-case studies.

The document primarily focuses on establishing "substantial equivalence" to a predicate device (AVANTICARE SA4022) by providing a comparison of specifications and intended use.

Here's a breakdown of why this document cannot fulfill your request:

  • No AI/ML Device: The device is an "Electrical scooter," a physical motorized vehicle, not a software algorithm or AI/ML-driven medical device.
  • No Acceptance Criteria for an Algorithm: The acceptance criteria in this document are for a physical product, primarily focusing on safety and performance specifications (e.g., maximum loading, speed, braking distance) compared to a predicate device, rather than diagnostic accuracy or performance metrics of an algorithm.
  • No "Study" in the AI/ML Sense: The document refers to a "substantial equivalence comparison" which is a technical comparison of specifications, not a clinical study to prove the performance of an AI model against a ground truth.

Therefore, I cannot extract the requested information like sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from 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).