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510(k) Data Aggregation

    K Number
    K093719
    Device Name
    PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#
    Manufacturer
    OSTEOGENICS BIOMEDICAL, INC.
    Date Cleared
    2010-03-01

    (89 days)

    Product Code
    DZL
    Regulation Number
    872.4880
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT#

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

    The Pro-Fix™ Precision Fixation System is used to stabilize, fixate and/or support bone grafts, bone filling materials and/or barrier membranes used for regeneration of bone in the oral cavity.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain the information requested. The document is an FDA 510(k) clearance letter for a medical device (Pro-Fix™ Precision Fixation System). It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements. However, it does not include any details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or clinical effectiveness studies (like MRMC studies) for an AI/algorithm-based device.

    Therefore, I cannot populate the table or answer the specific questions related to the performance study of an AI device.

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