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510(k) Data Aggregation

    K Number
    K970871
    Device Name
    TR NEEDLE
    Manufacturer
    GALLINI INTL., INC.
    Date Cleared
    1997-05-21

    (72 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    TR NEEDLE

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

    The needle is designed to be used for soft tissue histological biopsy.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that a device meets such criteria. The document is a 510(k) clearance letter from the FDA for a device called "TRTM Guillotine Needle," indicating its substantial equivalence to previously marketed devices for soft tissue histological biopsy.

    Therefore, I cannot provide the requested information, including:

    • A table of acceptance criteria and reported device performance.
    • Sample size and data provenance for a test set.
    • Number and qualifications of experts for ground truth.
    • Adjudication method for the test set.
    • Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
    • Results of a standalone algorithm-only performance study.
    • Type of ground truth used.
    • Sample size for the training set.
    • How ground truth for the training set was established.
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