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510(k) Data Aggregation

    K Number
    K992447
    Manufacturer
    Date Cleared
    1999-10-20

    (90 days)

    Product Code
    Regulation Number
    876.1500
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    50 W METAL HALIDE ILLUMINATOR, VES 0501.

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

    The 50 W Metal Halide Illuminator has indicated use in the following situations:

    • There is a requirement for illuminating medical headlamps.
    • There is a requirement for fiber-optic illumination for endoscopy applications.
    • There is a requirement to use video as a visual aid or a method of recording or both.
    • There is a requirement for any or all of the above at the same time.
    Device Description

    Not Found

    AI/ML Overview

    The provided document [0] is a 510(k) clearance letter from the FDA for a device called "VES 0501. 50 Watt Metal Halide Illuminator." This type of letter confirms substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

    The document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any of the other specific study-related details requested in the prompt.

    The closest information it provides in terms of device function are the "Indications For Use" listed in document [1], which describe where the device is intended to be used (illuminating medical headlamps, fiber-optic illumination for endoscopy, and with video systems). However, these are not performance metrics or acceptance criteria derived from a study.

    Therefore, I cannot fulfill the request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text. The document is merely a regulatory clearance, not a technical report or study summary.

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