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510(k) Data Aggregation

    K Number
    K960068
    Device Name
    SH-1 SURGICAL HOLDER FOR TELESCOPE
    Manufacturer
    OLYMPUS AMERICA, INC.
    Date Cleared
    1997-05-05

    (486 days)

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

    SH-1 SURGICAL HOLDER FOR TELESCOPE

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

    The Olympus SH-1 Surgical Holder for Telescope can be utilized for the manipulation and positioning of a telescope during laparoscopic procedures.

    Device Description

    Not Found

    AI/ML Overview

    This 510(k) summary for the Olympus SH-1 Surgical Holder for Telescope does not contain the detailed information required to answer your questions regarding acceptance criteria and a study proving device performance in the context of AI/software device evaluation.

    The provided document is for a mechanical surgical instrument (a telescope holder), not a software or AI-driven device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they apply to diagnostic performance (e.g., sensitivity, specificity, AUC) are not relevant here.

    Here's why the questions cannot be fully answered with the given input:

    • Acceptance Criteria & Reported Performance (Table 1): Mechanical devices are typically evaluated based on engineering specifications, material properties, safety tests (e.g., biocompatibility, sterilization validation, strength, durability, ease of use), and performance claims like "securely holds telescope." These are not reported in the provided summary. The summary only states its intended use and comparison to predicates.
    • Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set Size, and Ground Truth for Training (Questions 2-9): These are all specific to the evaluation of diagnostic or prognostic software/AI algorithms. They relate to the quantitative assessment of an algorithm's ability to interpret data (like images or patient records) against a known truth. A mechanical telescope holder does not perform such interpretations. Its "performance" is based on its physical properties and functionality during surgery, which would be assessed through different types of testing (e.g., bench testing, cadaver studies, animal studies, human factors testing if applicable).

    In summary, the provided document is a 510(k) summary for a traditional medical device, not a software device or AI-enabled device. Therefore, the questions posed, which are designed for the evaluation of AI/software performance, are not applicable to this device type and cannot be answered from the given information.

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