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510(k) Data Aggregation

    K Number
    K992619
    Device Name
    AMIGO MODEL 680000 (AMIGO EXCITE F 350)
    Manufacturer
    AMIGO MOBILITY INTL., INC.
    Date Cleared
    1999-10-25

    (82 days)

    Product Code
    ITI
    Regulation Number
    890.3860
    Type
    Traditional
    Panel
    Physical Medicine
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    AMIGO MODEL 680000 (AMIGO EXCITE F 350)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The subject device and the predicate device intended use The subject device and the produced individuals.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification approval letter from the FDA for a medical device called "Amigo Model 680000 Excite F350".

    This document does not contain any information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications for AI/ML device evaluation. It is a regulatory approval for a physical mobility device (presumably a powered wheelchair or scooter). Therefore, I cannot fulfill your request for information related to AI/ML device studies based on this document.

    The information sought in your prompt (e.g., sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) is typical for the evaluation of AI/ML-driven medical devices. However, this specific document predates the widespread use and regulatory frameworks for such devices and is for a different type of product entirely.

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