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510(k) Data Aggregation

    K Number
    K200817
    Device Name
    URIS OMNI Narrow System & Prosthetic
    Manufacturer
    TruAbutment Inc.
    Date Cleared
    2020-10-07

    (191 days)

    Product Code
    DZE,NHA
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K102436,K161689,K140507,K182091,K123755,K120951,K123988,K160670,K183518,K081748,K123664,K100756,K183106,K172100
    Why did this record match?
    Reference Devices :

    K161689, K140507, K182091, K123755, K120951, K123988, K160670, K183518, K081748, K123664, K100756, K183106

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

    URIS OMNI Narrow System is indicated for use in the treatment of missing maxillary lateral incisors or the mandbular central and lateral incisors, in support of single or multiple-unit restorations including: cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading.

    The URIS OMNI Prosthetic abutments are intended for use with URIS OMNI dental implants to provide support for prosthetic restorations such as crowns, bridges, or over-dentures.

    All digitally designed abutments and/or coping for use with URIS OMNI Prosthetic abutments are intended to be sent to a TruAbutment-validated milling center for manufacture.

    Device Description

    URIS OMNI Narrow System fixtures are dental implants made of Unalloyed Titanium, grade 4 (ASTM F67) intended for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors. The surface is SLA (Sandblasted, Large grit and Acid etched) treated and is provided sterile. It consists of two implant lines, the OMNI Straight and the OMNI Tapered, with corresponding cover screws, healing abutments and prosthetic abutments. The OMNI Tapered implant has a tapered wall with a single thread design. The OMNI Straight implant has straight wall with smaller threading at the coronal end, and bigger threading at the apical end. Both implant lines have Narrow (Ø 3.15 mm) platform sizes. Both implant lines share the following diameters and lengths.

    Ø 3.15 x 10, 11.5, 13, 14.5mm (L)

    URIS Prosthetic System is made of titanium alloy (Ti-6Al-4V ELI) intended for use as an aid in prosthetic restoration. It consists of Ball Abutment, Retainer, T LOC Straight Abutment, T Loc Titanium Cap, Multi-Unit Straight Abutment, Multi-Unit Angled Abutment, Multi-Unit Healing Cap, Multi-Unit Ti Cylinder, Multi-unit temporary cylinder, Multi-Unit Cylinder screw, URIS DS, URIS Base. No additional angulation is to be included in the when using a coping or cylinder (i.e., Multi-unit Ti Cylinder, Multi-unit Temporary Cylinder, Multi-unit Base) with any of the Multi-unit Abutments.

    URIS Base consists of a two-piece abutment, where the titanium base is a pre-manufactured abutment that will be used to support a CAD/CAM designed superstructure (the second part of the two-piece abutment) that composes the final abutment. URIS Base is made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.

    URIS DS abutment as a patient matched titanium abutment compatible with both URIS OMNI System (K172100) and URIS OMNI Narrow System (subject).

    AI/ML Overview

    The provided document is a 510(k) Summary for a dental implant system. It discusses the substantial equivalence of the "URIS OMNI Narrow System & Prosthetic" to predicate devices based on non-clinical testing. The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of human reader performance or a standalone algorithm performance for AI/ML-driven devices.

    The document states: "No clinical data were included in this submission." and focuses on demonstrating substantial equivalence through comparisons of technological characteristics and non-clinical test data.

    Therefore, I cannot provide the requested information for an AI/ML device related to acceptance criteria, detailed study design, sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, as these types of studies are not discussed in this 510(k) summary for this device.

    The "acceptance criteria" presented in this document are primarily related to the successful completion and results of non-clinical tests to demonstrate equivalence to predicate devices. These are not performance metrics for an AI/ML algorithm.

    Here's an analysis of what is provided regarding acceptance criteria in the context of this traditional medical device:

    1. A table of acceptance criteria and the reported device performance:

    The document implicitly defines acceptance criteria by listing the standards to which tests were performed and stating that "the results have met the criteria of the standards." The "reported device performance" is that it successfully met these standards, thereby demonstrating substantial equivalence.

    Acceptance Criteria (Standards Met)Reported Device Performance
    USP and USP for Bacterial EndotoxinMet the criteria of the standards
    ISO 10993-1 for BiocompatibilityMet the criteria of the standards
    ISO 11137-1,-2,-3 and ISO 11737-1,-2 for SterilizationMet the criteria of the standards
    ISO 17665-1,-2 for End user sterilizationMet the criteria of the standards
    ISO 11607-1,-2 / ASTM F1980-07, ASTM F88, ASTM F1140, ASTM F1929, ASTM F2096 and sterility testing for Shelf LifeMet the criteria of the standards
    ISO 14801:2016 and FDA Guidance for Fatigue TestingMet the criteria of the standards ("worst-case scenario")
    SEM and EDS analysisPerformed (implied acceptable by equivalence conclusion)

    2. Sample size used for the test set and the data provenance:
    Not applicable for this type of non-clinical, non-AI device study. The document refers to testing on the device itself (e.g., fatigue testing, sterilization testing, biocompatibility).

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
    Not applicable. Ground truth as typically understood for AI/ML performance is not relevant here. The "ground truth" for these tests would be the accepted parameters and methods defined by the referenced ISO/ASTM standards and FDA guidance.

    4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
    Not applicable. This is not a human reader or AI performance study.

    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:
    No. This is not an AI/ML device.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
    No. This is not an AI/ML device.

    7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
    Not applicable in the context of AI/ML device performance. For the described non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the referenced ISO/ASTM standards. For example, for biocompatibility, the ground truth is whether the materials meet the criteria specified in ISO 10993-1.

    8. The sample size for the training set:
    Not applicable. This is not an AI/ML device.

    9. How the ground truth for the training set was established:
    Not applicable. This is not an AI/ML device.

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