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510(k) Data Aggregation

    K Number
    K982960
    Device Name
    MEICAL DEVICE TECHNOLOGIES, INC. TRU-CORE DISPOSABLE AUTOMATIC BIOPSY INSTRUMENT
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    1998-09-23

    (30 days)

    Product Code
    KNW
    Regulation Number
    876.1075
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    K962969,K982085
    Why did this record match?
    Reference Devices :

    K962969, K982085

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

    The Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

    Device Description

    The Tru-Core™ Disposable Automatic Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

    AI/ML Overview

    This document is a 510(k) summary for the Tru-Core™ Disposable Automatic Biopsy Instrument and does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.

    The 510(k) summary focuses on the device's substantial equivalence to previously marketed devices and its intended use. It does not include details on:

    • A table of acceptance criteria and reported device performance.
    • Sample size or data provenance for a test set.
    • Number or qualifications of experts for ground truth establishment.
    • Adjudication methods.
    • Multi-reader multi-case (MRMC) comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used in a performance study.
    • Sample size for a training set.
    • How ground truth for a training set was established.

    Therefore, I cannot provide the requested information based on the provided text.

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