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510(k) Data Aggregation

    K Number
    K972308
    Device Name
    MEDNEXT 1000 DRILL
    Manufacturer
    MEDNEXT, INC.
    Date Cleared
    1997-08-20

    (61 days)

    Product Code
    GEY
    Regulation Number
    878.4820
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MEDNEXT 1000 DRILL

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

    To provide power to operate various accessories to cut hard tissue, bone, soft tissue.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the detailed study information required to answer your request. The document is a 510(k) clearance letter for a "Med'ext 1000 Surgical Drill," indicating it has been deemed substantially equivalent to a predicate device. However, it does not include:

    • A table of acceptance criteria or reported device performance.
    • Information on sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
    • Details about multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
    • The type of ground truth used or how it was established for either test or training sets.
    • The sample size for the training set.

    The document primarily focuses on the regulatory clearance of the device based on substantial equivalence, rather than a detailed performance study report.

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