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510(k) Data Aggregation

    K Number
    K984035
    Manufacturer
    Date Cleared
    1999-06-03

    (203 days)

    Product Code
    Regulation Number
    882.4310
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    XK-95 HIGH SPEED MOTOR DRILL SYSTEM

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

    High Speed Drall Syst પ્રાહ-95 for use during neurological to provide power to ope proc or attachments acı assurili

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a clearance letter from the FDA for a medical device called the "XK-95 High Speed Motor Drill System." It confirms that the device is substantially equivalent to a previously marketed device. However, this document does not contain any information regarding:

    • Acceptance criteria for the device's performance.
    • Study details proving the device meets acceptance criteria.
    • Sample sizes for test or training sets.
    • Data provenance.
    • Number or qualifications of experts for ground truth.
    • Adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance.
    • Type of ground truth used.
    • How ground truth was established.

    This document is solely a regulatory approval letter based on "substantial equivalence" to a predicate device, not a performance study report. Therefore, I cannot fulfill your request for the specific information listed.

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