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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.

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.

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.

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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The iMARK™ Internal Hexagon 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 IMARK™ Internal Hexagon 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 can also be used for single tooth restorations. The IMARK™ Internal Hexagon Dental Implant System uses a two-stage implantation process.

The iMARK™ Internal Hexagon Dental Implant System is compatible with Zimmer® Tapered Screw Vent prosthetics.

The ACE Surgical iMARK™ Internal Hexagon Dental Implant System is a screw type dental implant system designed with technology established with the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The ACE Surgical iMARK™ Internal Hex dental implant screw raw material is made of Ti-6-AL-4V ELI per ASTM F13& standard and surface treated with resorbable blast media (RBM). The self tapping internal horning and features tapered external thread geometry consistent with industry standard screw implant fixtures. The implants are provided sterile and sterility is achieved by gamma radiation pursuant to ISO 11137

The provided text describes the 510(k) summary for the ACE Surgical iMARK™ Internal Hexagon Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than an AI-based device's performance against specific acceptance criteria in a clinical study. Therefore, much of the requested information (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance, training set details) is not applicable to this type of submission.

However, I can extract the relevant performance characteristics that were tested and the type of ground truth used (in this case, mechanical test standards and predicate device performance).

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in the document (typical for mechanical testing, usually a small number of samples per test type to meet standard requirements).
• Data Provenance: Not specified, but generally, mechanical testing is performed in a controlled laboratory environment. Retrospective/prospective distinction is not applicable here.

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

• Not applicable. The "ground truth" for mechanical testing is established by adherence to recognized industry standards (e.g., ASTM F13, ISO 11137) and comparison to predicate device performance, not by expert consensus on data interpretation.

4. Adjudication method for the test set

• Not applicable. Adjudication methods (like 2+1, 3+1) are used for expert review of clinical data, not for mechanical performance testing.

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

• Not applicable. This is not an AI-based device, and therefore no MRMC study was performed.

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

• Not applicable. This is a medical implant, not an algorithm.

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

• The "ground truth" or reference for the mechanical testing was primarily based on:
  • Industry Standards: Adherence to established mechanical testing standards (e.g., relevant ASTM standards for materials and ISO standards for sterilization).
  • Predicate Device Performance: Comparison of the new device's mechanical performance to that of legally marketed predicate devices (ACE Surgical Screw Dental Implant System K954513 and Zimmer® Tapered Screw Vent Dental Implant K011028) to demonstrate "substantial equivalence."

8. The sample size for the training set

• Not applicable. This is a medical implant, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established

• Not applicable. There is no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its acceptance criteria involved a series of mechanical tests designed to demonstrate the material properties, structural integrity, and functional performance of the ACE Surgical iMARK™ Internal Hex Dental Implant System. These tests included:

• Torsional insertion: To assess the torque required for placement/insertion.
• Shear (coaring): To evaluate resistance to shearing forces.
• Compressive bending: To test the implant's ability to withstand compressive and bending loads.
• Fatigue strength: To determine the implant's durability under repeated stress cycles, simulating physiological conditions over time.

These tests were performed to support the substantial equivalence of the iMARK™ system to two predicate devices: the ACE Surgical Screw Dental Implant System (K954513) and the Zimmer® Tapered Screw Vent Dental Implant (K011028). The implicit "acceptance criteria" for these tests were that the new device's performance characteristics must be comparable to or better than those of the predicate devices, thereby demonstrating that it is as safe and effective.

Additionally, material composition (Ti-6-AL-4V ELI per ASTM F13 standard) and sterilization methods (gamma radiation per ISO 11137) were confirmed to meet recognized standards, further supporting the device's safety and effectiveness. The successful completion of these tests, leading to a determination of substantial equivalence by the FDA, indicates that the device met the necessary performance characteristics for market clearance.

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