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510(k) Data Aggregation

    K Number
    K961605
    Device Name
    KARL STORZ 10.5 FR. FLEXIBLE HYSTEROSCOPE
    Manufacturer
    KARL STORZ ENDOSCOPY-AMERICA, INC.
    Date Cleared
    1996-11-13

    (202 days)

    Product Code
    HIH
    Regulation Number
    884.1690
    Type
    Traditional
    Panel
    Obstetrics/Gynecology
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The KSEA flexible hysteroscope is intended for hysteroscopy.

    Device Description

    The KSEA 10.5 Fr. flexible hysteroscope is a manually operated, reusable surgical device consisting of a flexible fiberscope with working channel The instrument is long enough to gain access to the uterus.

    AI/ML Overview

    The provided document is a 510(k) summary for a Karl Storz 10.5 Fr. Flexible Hysteroscope. This document does not contain any information about acceptance criteria or a study proving device performance against such criteria.

    The document primarily focuses on:

    • Device Identification: Common and trade names, indication, and a brief description.
    • Substantial Equivalence Claim: Stating that the device is substantially equivalent to predicate devices and that minor differences do not raise new safety or effectiveness issues.

    There is no mention of an algorithm, AI, or any performance metrics that would require a study with sample sizes, ground truth establishment, or expert adjudication. Therefore, I cannot generate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement.

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