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510(k) Data Aggregation

    K Number
    K091968
    Device Name
    KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    2009-09-14

    (75 days)

    Product Code
    FCW
    Regulation Number
    876.1500
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C

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

    The Karl Storz LED NOVA 100 Cold Light Fountain is indicated for use to transmit light through an optical cable to an endoscope in order to illuminate the site of surgery during minimally invasive endoscopic surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter for a medical device (Karl Storz LED NOVA 100 Cold Light Fountain) and its indications for use. It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical study details of the nature you've requested (e.g., MRMC studies, effect sizes of AI assistance).

    The document is purely administrative, confirming that the device is substantially equivalent to a predicate device for its intended use as a light source for endoscopes. Therefore, I cannot extract the information you've asked for from this text.

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