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510(k) Data Aggregation

    K Number
    K964018
    Device Name
    PHACOILLUMINATOR - FIBEROPTIC SLEEVE
    Manufacturer
    MICHAEL REYNARD, M.D.
    Date Cleared
    1997-02-26

    (142 days)

    Product Code
    HQC
    Regulation Number
    886.4670
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    K971750
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Provide illumination at surgical site.

    Device Description

    Clear silicone sleeve that transmits light originating from fiber optic channels contained in the phacofragmentation handpiece.

    AI/ML Overview

    I am sorry, but the provided text describes a medical device called "Phacoilluminator™" for surgical illumination, specifically a clear silicone sleeve designed to transmit light during phacofragmentation procedures.

    The text does not contain any information about acceptance criteria, device performance metrics, study details (like sample size, data provenance, expert qualifications, adjudication methods), statistical studies (MRMC, standalone), or ground truth establishment relevant to the questions you've asked. It is a very brief 510(k) summary from 1997 focusing on the device's description and equivalence to existing devices.

    Therefore, I cannot fulfill your request for a table of acceptance criteria and reported performance, nor can I provide details on the study design, as this information is absent from the provided input.

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