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510(k) Data Aggregation

    K Number
    K983142
    Device Name
    KSEA C-MOUNT ARTHROSCOPES
    Manufacturer
    KARL STORZ ENDOSCOPY
    Date Cleared
    1998-12-07

    (90 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    KSEA C-MOUNT ARTHROSCOPES

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

    The KSEA C-Mount Arthroscope is intended for large joint arthroscopic procedures.

    These instruments are manually operated surgical devices intended for arthroscopic procedures of the shoulder and knee.

    Device Description

    The Karl Storz C-Mount Arthroscope are manually operated surgical devices. The KSEA C-Mount Arthroscope are 30° and 70° view Telescopes. The body contact portions of the KSEA C-Mount Arthroscope are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.

    AI/ML Overview

    The provided document is a 510(k) summary for the Karl Storz C-Mount Arthroscope, which is a manually operated surgical device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies, as described in your request.

    The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting performance data from clinical or standalone studies. Therefore, I cannot extract the requested information from this document.

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