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510(k) Data Aggregation

    K Number
    K052103
    Device Name
    EXEL SECURE TOUCH II SAFETY SYRINGE
    Manufacturer
    EXELINT INTL. CO.
    Date Cleared
    2005-10-19

    (77 days)

    Product Code
    MEG
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    EXEL SECURE TOUCH II SAFETY SYRINGE

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

    This Device is a Safety Hypodermic Syringe for injection of medicine to patients. This device aids in the prevention of needlestick injuries.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter from the FDA for a safety syringe, not a study report for an AI/ML medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, device performance, study design, or ground truth establishment.

    Specifically, the document:

    1. Does not describe acceptance criteria for an AI/ML device.
    2. Does not report device performance against any such criteria.
    3. Does not detail any study involving AI/ML.
    4. Does not mention sample sizes, data provenance, expert qualifications, or adjudication methods.
    5. Does not refer to MRMC comparative effectiveness studies or standalone algorithm performance.
    6. Does not discuss ground truth types or how ground truth was established.
    7. Does not specify training set sizes.

    The document is a regulatory approval for a physical medical device (a safety syringe) based on substantial equivalence to a predicate device, as opposed to performance against specific efficacy or accuracy metrics typically associated with AI/ML device studies.

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