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510(k) Data Aggregation

    K Number
    K080074
    Device Name
    ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX
    Manufacturer
    ACE SURGICAL SUPPLY CO., INC.
    Date Cleared
    2008-02-14

    (34 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K061397,K951392
    Why did this record match?
    Device Name :

    ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX

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

    The ACE Tru-FIX™ Implant System is indicated for use to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects.

    Device Description

    The ACE Tru-FIX™ Implant System is a set of machined surgical grade titanium alloy (Ti-OAL-AV ELI) screws, intended to stabilize and support bone graft and or fractured bone segments with or without bone plates or titanium mesh in oral and maxillofacial site defects. The implants are supplied sterile in 3.0 mm and 15 mm, in standard tray packaging and include placement instruments. The screw raw material is Ti-6-AL-4V ELI per ASTM F136 standard. The candidate devices are identical in the screw raw materials and characteristics to that cleared under K951392. These screws are supplied in ACE Surgical TRU-Fix™ trays. The ACE Surgical TRU-Fix™ Implant System is a comprehensive system retaining prosthetic components, if applicable, of the ACE Surgical Orthodontic Miniboneplate system.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary for the ACE Tru-FIX™ Implant System, which focuses on establishing substantial equivalence to previously marketed predicate devices rather than demonstrating performance against defined acceptance criteria through a clinical study.

    The core of this submission is a comparison of technological characteristics and intended use to predicate devices, using:

    1. Device description
    2. Indications for use
    3. Bench test results
    4. Materials
    5. Labeling

    It explicitly states: "In particular, the bench testing the ACE andidn's for use, 3) benefit test results, 17 materials, and by is effectiveness between the ACE Cal TRU-Fix™ Implant System and the specified predicate devices." This indicates that bench testing was performed, but details about specific acceptance criteria, methodology, sample sizes, and outcomes are not provided in this summary.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, ground truth, or expert involvement because this information is not present in the provided text.

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