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510(k) Data Aggregation

    K Number
    K103234
    Device Name
    GC AADVA BO AC ABUTMENTS
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2011-06-30

    (240 days)

    Product Code
    NHA
    Regulation Number
    872.3630
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K083871,K071370,K072100,K073258,K053373
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    "GC AADVA TI ABUTMENTS – BO AC SV BH" are dental implant abutments for use with partially or fully edentulous patients to restore chewing function by attachment to a dental implant fixture placed in the maxilla or mandible. Each abutment is accompanied by a screw in order to engage corresponding dental implant fixture.

    Device Description

    The "GC Aadva Ti Abutments – Bo Ac Sv Bh" are abutments which are placed into a dental implant to provide support for a prosthetic restoration. The subject abutments are indicated for use with the following implant fixtures: IN-Bo-3.3mm #354, IN-Bo-4.1mm #355, IN-Ac-3.5mm #356, IN-Ac-4.3mm #357, IN-Bh-3.8mm #358, IN-Bh-4.6mm #359, IN-Bh-5.8mm #360, IN-Sv-3.5mm #351, IN-Sv-4.5mm #352, IN-Sv-5.7mm #353. The "GC Aadva Ti Abutments – Bo Ac Sv Bh" components are made of Titanium grade Ti-6Al-4V and meets the requirements of ISO : 5832-3. The abutments are mounted into the implant with a screw also made of Titanium grade Ti-6A1-4V, which meets the requirements of ISO : 5832-3.

    AI/ML Overview

    The provided text describes the "GC AADVA TI ABUTMENTS – BO AC SV BH" and its substantial equivalence to predicate devices, focusing on materials, intended use, and performance characteristics.

    Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (from ISO 14801 and FDA Guidance)Reported Device Performance (Worst Case Scenario)
    Static Test Loads (Adequate)Test results demonstrated that the "GC Aadva Ti Abutments – Bo Ac Sv Bh" and implant-abutment assemblies support adequate static test loads.
    Fatigue Test Loads (Adequate)Test results demonstrated that the "GC Aadva Ti Abutments – Bo Ac Sv Bh" and implant-abutment assemblies support adequate fatigue test loads.
    Compatibility with Referenced Implant FixturesTest results demonstrated that the "GC Aadva Ti Abutments – Bo Ac Sv Bh" are compatible with the referenced implant fixtures.
    Performs as IntendedPerformance testing demonstrates that the device performs as intended.
    Safe and Effective (compared to predicates)Performance testing demonstrates that the device is as safe and effective as the cited predicates.

    2. Sample Size Used for the Test Set and Data Provenance:

    • Sample Size: The document does not specify the exact number of implant-abutment assemblies tested. It refers to testing on the "worst case scenario" implant-abutment combination assemblies.
    • Data Provenance: The study was conducted by GC America, Inc. and GC Corporation (manufacturer). The country of origin for the manufacturing is Japan (GC Corporation) and the submitter is in the US. The study is prospective in the sense that physical tests were performed on the device.

    3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

    • This information is not provided in the document. The "ground truth" for this type of device (dental abutments) is typically established through adherence to engineering standards and mechanical testing, not expert consensus or clinical observation in the same way a diagnostic device would. The "truth" is whether the device can withstand the specified loads without failure.

    4. Adjudication Method for the Test Set:

    • This information is not applicable as the evaluation is based on mechanical performance against predefined standards (ISO 14801 and FDA Guidance), not expert judgment requiring adjudication.

    5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

    • This is not applicable. The device is a dental implant abutment, not an AI-powered diagnostic or assistive technology. Therefore, no MRMC study or AI-related metrics like human reader improvement are relevant.

    6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

    • This is not applicable. The device is a physical medical device (dental abutment), not an algorithm or AI system.

    7. The Type of Ground Truth Used:

    • The ground truth used for this device is based on established engineering standards and regulatory guidance for mechanical performance. Specifically, the device's performance was evaluated against the requirements of ISO 14801 (Dentistry - Implants - Dynamic loading test for endosseous dental implants) and FDA's Guidance Document for Dental Implants. The "truth" is defined by meeting the specified static and fatigue load requirements.

    8. The Sample Size for the Training Set:

    • This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are refined through engineering principles and iterative testing, not through training data.

    9. How the Ground Truth for the Training Set was Established:

    • This is not applicable for the reasons stated above.
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