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510(k) Data Aggregation

    K Number
    K021098
    Device Name
    DAUM-LECTRIC MRI DRILLING MACHINE
    Manufacturer
    MRI DEVICES DAUM GMBH
    Date Cleared
    2002-12-03

    (243 days)

    Product Code
    ERL
    Regulation Number
    874.4250
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Daum p-lectric Drilling Machine is a piezoelectrically driven hand held drill intended to assist the surgeon to access bony tissue. The Daum p-lectric Drilling Machine can drill into hard and soft bone tissue to create a small hole or to obtain bony tissue samples. The Daum p-lectric Drilling Machine is designed to be used inside or close to an MRI Unit up to 1.5 Tesla.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is an FDA 510(k) clearance letter for a medical device called the "Daum x-lectric Drilling Machine." This document primarily focuses on the regulatory aspects of device clearance (substantial equivalence to a predicate device) and does not contain information about acceptance criteria or a study proving the device meets those criteria.

    Therefore, I cannot provide the requested information based on the input text. The document is a clearance letter, not a device performance study report.

    To answer your request, I would need a document that describes:

    • The specific performance criteria of the device.
    • The methodology and results of a study designed to test these criteria.
    • Details about the test set, ground truth establishment, training set, and expert involvement.
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