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510(k) Data Aggregation

    K Number
    K961244
    Device Name
    KSEA INSTRUMENTS FOR ENDOSCOPIC TREATMENT OF CARPAL TUNNEL SYNDROME
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-05-07

    (36 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are indicated for use in endoscopic carpal ligament release.

    Device Description

    The KSEA arthroscopes for use in endoscopic carpal ligament release are straight-shafted, rod-lens telescopes. Accessories are available for use with the arthroscopes include sheaths, obturators, knives, dilators, and a retractor with guiding tube. The body contact materials present in these devices are commonly used in medical devices for a wide range of applications, and have a long history of biocompatability for human use.

    AI/ML Overview

    The provided text describes a 510(k) summary for Karl Storz Endoscopy instruments, focusing on their substantial equivalence to predicate devices for endoscopic carpal ligament release.

    However, the document does not contain any information regarding acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication methods), or AI-related effectiveness studies (MRMC or standalone).

    Therefore, I cannot extract the requested information. The text primarily addresses regulatory aspects of substantial equivalence based on design and intended use, rather than detailed performance study outcomes.

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