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510(k) Data Aggregation

    K Number
    K003646
    Manufacturer
    Date Cleared
    2001-02-22

    (87 days)

    Product Code
    Regulation Number
    886.5700
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUTUREGROOVE WEIGHT SIZING SET

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K994289
    Device Name
    SUTUREGROOVE
    Manufacturer
    Date Cleared
    2000-04-17

    (118 days)

    Product Code
    Regulation Number
    886.5700
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SUTUREGROOVE

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

    SutureGroove Gold Eyelid Weights are indicated for the gravityassisted treatment of the functional defects of lagophthalmos resulting from facial paralysis. This is intended to protect against corneal exposure keratitis and improve cosmesis

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but based on the provided text, there is no information about the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is primarily a 510(k) clearance letter for the "Suture Groove™ Gold Eyelid Weight Implant," stating that the device is substantially equivalent to legally marketed predicate devices. It outlines the regulatory classification, general controls, and indications for use.

    Therefore, I cannot provide the requested table, sample sizes, expert qualifications, adjudication methods, details on MRMC studies, standalone performance, training set information, or ground truth establishment. This information is typically found in a clinical study report or a premarket submission summary, which is not present in the given text.

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