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510(k) Data Aggregation

    K Number
    K191997
    Device Name
    FAICO CMF System
    Manufacturer
    FAICO Medical LLC
    Date Cleared
    2020-04-22

    (271 days)

    Product Code
    JEY,DZL
    Regulation Number
    872.4760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    FAICO CMF System is implantable bone plates and bone screws for maxillofacial and mandible surgery procedures including:

    1. Fractures
    2. Osteotomies
    3. Reconstructive procedures
    4. Revision procedures where other treatments or devices have failed.
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a medical device called the "FAICO CMF System." This document primarily focuses on regulatory approval based on substantial equivalence to existing devices and outlines the indications for use.

    It does not contain information about acceptance criteria, specific device performance data, study designs (sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set details for AI/algorithm-based devices.

    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. The document is a regulatory approval, not a scientific study report.

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