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510(k) Data Aggregation

    K Number
    K103790
    Device Name
    ACE TRIMARK TRICAM DENTAL IMPLANT
    Manufacturer
    ACE SURGICAL SUPPLY COMPANY INC.
    Date Cleared
    2011-08-18

    (234 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K954513,K023113,K053654
    Why did this record match?
    Device Name :

    ACE TRIMARK TRICAM DENTAL IMPLANT

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

    The TriMark™ TriCam™ Dental Implant System is used in indications for oral endosseous implants in the maxilla and/or mandible as part of a functional and aesthetic oral rehabilitation in partial or fully edentulous patients.

    The TriMark™ TriCam™ Dental Implant System is designed for use in totally edentulous mandibles or maxillae or as a terminal or intermediary abutment for fixed or removable bridgework. The system is intended for use with all standard straight abutment prosthetics and is not intended for use with angled intents. The system can also be used for single tooth restorations. The TriMark™ TriCam™ Dental Implant System uses a two-stage implantation process and is not intended for immediate loading.

    The TriMark™ TriCam™ Dental Implant System is compatible with 0 (zero) degree, straight version of the Atlantis™ Abutment for Nobel Replace Interface.

    Device Description

    The ACE Surgical TriMark™ TriCam™ Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Implant System (K954513) designed with technology occubilent (K023113). The ACE Surgical TriMark™ TriCam™ Dental Implant is made of Ti-6-AL-4V ELI per ASTM F136 standard and surface treated with resorbable blast media (RBM). The TriCam™ Dental Implant tapered external thread geometry is consistent with industry standard screw implant fixtures. A cover screw is included with each implant to protect the internal features of the implants are provided sterile and sterile and sterily is achieved by gamma radiation pursuant to ISO 11137.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the ACE Surgical TriMark™ TriCam™ Dental Implant System.

    Here's an analysis of the provided text in the context of your request:

    Acceptance Criteria and Device Performance

    The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format typical of AI/software approval. Instead, it demonstrates substantial equivalence to predicate devices based on a comparison of characteristics and mechanical testing.

    Acceptance Criteria (Implied by Substantial Equivalence to Predicates)Reported Device Performance (ACE Surgical TriMark™ TriCam™)
    Material Composition: Material must be compatible with existing dental implants.Made of Ti-6-AL-4V ELI per ASTM F136 standard. Similar to predicate devices (titanium alloy, commercially pure titanium).
    Surface Treatment: Must have a roughened surface treatment comparable to predicate devices.Surface treated with resorbable blast media (RBM). Comparable roughened surface treatments to predicate devices.
    Diameters: Must be offered in diameters comparable to predicate devices.Offered in diameters of 3.5; 4.3 and 5.0mm external thread diameters. Similar to predicate devices.
    Lengths: Must be offered in lengths comparable to predicate devices.Offered in lengths 8-16mm. Similar to predicate devices (8-16mm).
    Internal Threads: Must have internal threads comparable to predicate devices.Has 1.8 and 2.0mm metric internal threads. Similar to predicate devices.
    Sterilization Method: Must be sterilized by methods identical to predicate devices.Sterilized by gamma radiation pursuant to ISO 11137. Packaged and sterilized by identical methods to predicate devices.
    Implantation Process: Must utilize a compatible implantation process.Uses a two-stage implantation process. Similar to one predicate (ACE Screw Implant); one predicate (Nobel Biocare™) uses one or two stages.
    Mechanical Performance: Must demonstrate comparable mechanical strength and durability.Torsional insertion and shear loading: Data demonstrates substantial equivalence to predicate devices.
    Compressive bending: Data demonstrates substantial equivalence to predicate devices.
    Fatigue strength: Data demonstrates substantial equivalence to predicate devices.

    Study Details

    The provided document describes a non-clinical mechanical study for a physical medical device (dental implant), not an AI/Software as a Medical Device (SaMD). Therefore, many of your requested criteria (related to AI performance, ground truth, expert review, MRMC studies, etc.) are not applicable to this submission.

    Here's an breakdown based on the context of this specific device:

    1. Sample size used for the test set and the data provenance:

      • The document refers to "data generated from these tests" for mechanical performance, implying tests were conducted on physical samples of the device.
      • Not explicitly stated for the test set. The number of physical implants tested for each mechanical performance characteristic (e.g., torsional insertion, shear loading, compressive bending, fatigue strength) is not provided.
      • Data provenance: The tests were conducted on the ACE Surgical TriMark™ TriCam™ Dental Implant itself. No country of origin for data is mentioned beyond the manufacturing location (Brockton, MA, USA). The study is inherent to the device's design verification and validation. It is prospective in the sense that the tests were performed specifically to support this 510(k) submission.

    2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

      • Not applicable. This is a mechanical device, not an AI/software. There is no "ground truth" established by experts in the context of diagnostic accuracy. Mechanical tests follow established engineering standards.

    3. Adjudication method for the test set:

      • Not applicable. This pertains to expert review for diagnostic outcomes, which is not relevant for mechanical device testing.

    4. 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. An MRMC comparative effectiveness study is not relevant for a physical dental implant. This type of study is specifically for evaluating the impact of AI on human reader performance, typically in imaging diagnostics.

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

      • No. This is not an algorithm or AI device.

    6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

      • Not applicable. For mechanical testing, the "ground truth" is typically defined by engineering standards (e.g., ASTM F136 for material, relevant ISO standards for sterilization, or internal company specifications for mechanical performance derived from predicate device performance). The performance is measured against these established physical and engineering benchmarks.

    7. The sample size for the training set:

      • Not applicable. This device does not use a "training set" like an AI model.

    8. How the ground truth for the training set was established:

      • Not applicable. This device does not have a "training set" and therefore no ground truth was established for it in that context.
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