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510(k) Data Aggregation

    K Number
    K031309
    Device Name
    KUANN DAH, COOL TANK MOTORIZED SCOOTER, KS4L320
    Manufacturer
    KUANN DAH INDUSTRY CO., LTD.
    Date Cleared
    2003-07-31

    (98 days)

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

    The device is intended for medical purposes to provide mobility to persons restricted to a seated position.

    Device Description

    KUANN DAH, COOL TANK Motorized Scooter, KS-4L320

    AI/ML Overview

    I'm sorry, but this document is a 510(k) clearance letter from the FDA for a motorized scooter. It details the regulatory approval process for the device, including its classification and indications for use.

    However, it does not contain any information about:

    • Acceptance criteria or reported device performance metrics in the context of a study.
    • Sample sizes for test sets or their data provenance.
    • Number or qualifications of experts used for ground truth.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used (e.g., pathology, outcomes data).
    • Sample size for a training set.
    • How ground truth for a training set was established.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is purely administrative regulatory correspondence.

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