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510(k) Data Aggregation

    K Number
    K180092
    Device Name
    Intellitorq
    Manufacturer
    Gauthier Biomedical, Inc.
    Date Cleared
    2018-03-08

    (55 days)

    Product Code
    HXC
    Regulation Number
    888.4540
    Type
    Traditional
    Panel
    Orthopedic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is intended to indicate the applied torque according to the set target torque value. This device is intended for use in surgical procedures on bone and tissue by a surgeon trained in its intended use.

    Device Description

    Not Found

    AI/ML Overview

    I apologize, but the provided text focuses on an FDA 510(k) clearance letter for a device called "Intellitorq." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory compliance requirements.

    However, the text does not contain any information regarding acceptance criteria, specific study details, sample sizes, ground truth establishment, or expert qualifications related to the device's 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 input. The document is solely an administrative FDA communication, not a performance study report.

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