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    K Number
    K980822
    Device Name
    TITANIUM PEG SYSTEM
    Manufacturer
    FCI OPHTHALMICS, INC.
    Date Cleared
    1998-07-09

    (128 days)

    Product Code
    MQU
    Regulation Number
    886.3320
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TITANIUM PEG SYSTEM

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

    This system is designed to drill hydroxyapatite orbital implants and place a motility peg for coupling to the artificial eye. It may also be used to replace a previous sleeve or a previous peg.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the "Titanium Peg System," indicating that the device is substantially equivalent to legally marketed predicate devices.

    The text does not include:

    • A table of acceptance criteria and reported device performance.
    • Details about sample sizes, data provenance, or ground truth establishment for any study.
    • Information on expert reviews, adjudication methods, or MRMC studies.
    • Results from standalone algorithm performance.
    • Details about training sets.
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