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510(k) Data Aggregation

    K Number
    K964919
    Device Name
    EMERALD MEDICAL, INC. NUCLEUS PULPOSIS EVACUATOR SYSTEM
    Manufacturer
    EMERALD MEDICAL, INC.
    Date Cleared
    1997-01-28

    (50 days)

    Product Code
    HRX
    Regulation Number
    888.1100
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    K941709
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K941709

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

    The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.

    Device Description

    The EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System is an assortment of surgical instruments utilized in minimally invasive percutaneous lumbar discectorny surgical procedures.

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested in your prompt. The document is a 510(k) summary for the EMERALD MEDICAL, INC. Nucleus Pulposis Evacuator System, which focuses on establishing substantial equivalence to previously marketed predicate devices. It discusses the device's purpose and its similarity to existing systems but does not include:

    • Acceptance criteria or reported device performance metrics.
    • Details of any specific study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance).
    • Information about training sets.

    Therefore, I cannot provide a response filling in the requested table and study details based on the given input.

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