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510(k) Data Aggregation

    K Number
    K163185
    Device Name
    OptiLux LED Illuminator
    Manufacturer
    ISOLUX LLC
    Date Cleared
    2016-11-21

    (7 days)

    Product Code
    HBI
    Regulation Number
    878.4580
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Isolux Ilc OptiLux LED Illuminator is indicated for use in transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an Indications for Use statement for the "OptiLux LED Illuminator." These documents, from the FDA, confirm the device's regulatory clearance and its intended use but do not contain any information regarding acceptance criteria, device performance studies, or data about the device's accuracy or efficacy.

    Therefore, I cannot fulfill your request for information on the following:

    1. A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
    2. Sample size used for the test set and the data provenance: Not available.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
    4. Adjudication method for the test set: Not available.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not available.
    6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The OptiLux LED Illuminator is a physical device for illumination, not an algorithm. Therefore, this type of study is not applicable, and no information about it would be found here.
    7. The type of ground truth used: Not applicable and not available.
    8. The sample size for the training set: Not applicable and not available.
    9. How the ground truth for the training set was established: Not applicable and not available.

    The documents primarily focus on:

    • The FDA's determination of substantial equivalence to a predicate device.
    • The regulatory classification of the device (Class II).
    • The indications for use: "transmitting light for illumination purposes from an LED source via a fiber optic cable and attached to either an endoscope, surgical head light or other tools that contain in providing illumination to body cavities during examinations or surgical procedures."
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