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510(k) Data Aggregation

    K Number
    K023961
    Device Name
    SCOUT BOSS
    Manufacturer
    BURKE, INC.
    Date Cleared
    2002-12-24

    (25 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    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 SCOUT BOSS is a motorized, battery powered wheelchair for indoor/outdoor mobility purposes by larger disabled individuals.

    Device Description

    Not Found

    AI/ML Overview

    This is a medical device marketing authorization from the FDA for a powered wheelchair, the "Scout Boss." It is not a study describing a device that uses AI/ML or an algorithm-based diagnostic. Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not applicable to this document.

    This document is a 510(k) clearance letter, which means the device (a powered wheelchair) was found to be "substantially equivalent" to a legally marketed predicate device. This process typically involves demonstrating that the new device has the same intended use, technological characteristics, and safety and effectiveness as the predicate device, often through engineering tests and comparisons rather than clinical studies in the context of diagnostic accuracy.

    Therefore, I cannot provide the requested information as it is not present in the provided text.

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