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510(k) Data Aggregation

    K Number
    K974735
    Device Name
    STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD 45 DEGREE BLADE
    Manufacturer
    AARON MEDICAL INDUSTRIES
    Date Cleared
    1998-06-24

    (188 days)

    Product Code
    JOS,GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    STANDARD AND EXTENDED BLADE, NEEDLE AND BALL; MODIFIED STANDARD AND EXTENDED BLADE & NEEDLE; STANDARD

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

    Device is used for cutting and/or coagulation during open surgical procedures.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text is a 510(k) clearance letter from the FDA for an electrosurgical device. It primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device.

    The document does not contain information about:

    • Acceptance criteria for a study.
    • Detailed study design or methodology.
    • Device performance metrics from a study.
    • Sample sizes for test or training sets.
    • Ground truth establishment methods.
    • Information on expert qualifications or adjudication methods.
    • MRMC comparative effectiveness studies.
    • Standalone algorithm performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This document is a regulatory approval, not a scientific study report.

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