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510(k) Data Aggregation

    K Number
    K983859
    Device Name
    SPECTRUM SMALL FRY
    Manufacturer
    FREEDOM DESIGNS, INC.
    Date Cleared
    1998-11-25

    (30 days)

    Product Code
    IOR
    Regulation Number
    890.3850
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This wheelchair is designed as a transport base for ... . . pediatric clients. This device will not diagnose, treat, prevent, cure or mitigate any of the population of its' intended users.

    Device Description

    Spectrym Small Fry Manual Folding Mobility Wheelchair

    AI/ML Overview

    This document is a 510(k) premarket notification from the FDA, approving a "Manual Folding Mobility Wheelchair". It does not contain information about acceptance criteria or a study proving the device meets said criteria, in the way one would describe for a diagnostic or AI-powered medical device.

    The document is a regulatory approval for a physical medical device (a wheelchair), not a software or diagnostic device. Therefore, the questions related to performance metrics like sensitivity, specificity, sample sizes, expert ground truth, MRMC studies, or training sets are not applicable to this type of submission.

    The FDA's approval for this device is based on a determination of "substantial equivalence" to devices already marketed, not on a clinical performance study with statistical endpoints.

    Therefore, I cannot provide the requested information from the provided text.

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