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The Dentsply Sirona Titanium Bases system is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For AT EV 3.0 S, AT TX 3.0 S, BH 3.0 S, and SB L 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

The system comprises three parts:

• Abutment Block material (CEREC Cercon 4D Abutment Block)
• Titanium Base (TiBase)
• CAD/CAM system

The TiBase is recommended for use with two-piece hybrid abutments and hybrid abutment crowns, used in conjunction with endosseous dental implants.

The proposed Dentsply Sirona Titanium Bases system are connected to Dentsply Sirona or third-party dental implants to facilitate the prosthetic dental restoration of edentulous areas of the oral anatomy. The proposed TiBase components are assembled (through extraoral cement bonding) with the patient specific CEREC Cercon 4D Abutment Block (K234018), to form the complete, two-piece CAD/CAM Titanium Base system abutments. The bottom half of the abutment is the TiBase component, which interfaces with the implant system-specific geometry, while the top half of the abutment is the abutment block material that is milled to form either an abutment crown or a meso-structure (the latter is subsequently finished with a crown). The TiBase component therefore serves as the "platform" on which the customized milled abutment crown or the meso-structure is bonded to, forming the complete CAD/CAM Titanium Base system abutment. The completed CAD/CAM Titanium Base system abutment is attached to the dental implant with an abutment screw.

The TiBase system is part of a workflow that includes CAD/CAM software cleared in predicate device, K193408, CAD/CAM system with CEREC Chairside Software, and reference device, K200191, CAD/CAM System with inLab Software, and the abutment crown and meso-structure material cleared in reference device, K234018.

The TiBase components are made of the same material as the predicate device (K193408) TiBases, which is titanium alloy Ti6Al4V, complying with ASTM F136-13. While the lower part connects to the implant system, the upper part consists of a tapered, cylindrical center post which is designed to receive the abutment crown or meso-structure to complete the finished CAD/CAM abutment.

The TiBase components come in small and large sizes depending on the diameter size of the connecting implant. A notch feature on the cylindrical part of the upper portion (i.e. rotational reference and lock) ensures that there is only one position to mount either a scanbody or the abutment crown/meso-structure.

The TiBase component center post includes a through-channel through which a corresponding abutment screw is inserted to allow retention of the finished abutment to the implant. The abutment screw, made of the same Titanium material, when assembled with the proposed TiBase component, is located in the internal geometry of the titanium base and does not seat in the finalized abutment crown/meso-structure.

The minimum/maximum design specification limits are as follows:

• Maximum angulation for the Zirconia top-half material: 20˚
• Minimum wall thickness of the Zirconia top-half material: 0.5 mm
• Gingival heights of the TiBase component: 1, 2, 3 mm
• TiBase component post height (i.e., length above the gingival height): ≥ 4 mm

This document is a 510(k) clearance letter for the Dentsply Sirona Titanium Bases system, which specifies its indications for use and compares it to predicate and reference devices to demonstrate substantial equivalence. It does not describe the specific acceptance criteria and detailed study results that prove the device meets those criteria in a format applicable to AI/ML software performance studies.

The document details the technical aspects of the dental implant components and their mechanical testing for safety and performance (e.g., fatigue testing), biocompatibility, reprocessing validation, and MR compatibility. However, it does not involve the types of performance metrics, test set characteristics, or ground truth establishment typically associated with AI/ML device evaluations.

Therefore, for aspects related to AI/ML device performance (like accuracy metrics, expert review, MRMC studies, standalone performance), the answer is "Not applicable" or "Not provided" as this is a traditional medical device clearance, not an AI/ML software clearance.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical tests that the device was subjected to and that it "met acceptance criteria" or "showed similar results" to reference devices. However, the specific quantitative acceptance criteria (e.g., "fatigue strength must be > X N") and the exact reported quantitative performance values achieved by the Dentsply Sirona Titanium Bases system are not explicitly stated in this clearance letter. The letter generally refers to compliance with standards.

For example, for fatigue testing, it states: "The TiBases systems were subjected to fatigue testing per the following requirements and showed similar results when compared to the reference devices (K213961, K241485)" and refers to ISO 14801:2016 and FDA Special Controls Guidance. It does not provide the numerical results or the specific acceptance mechanical load values. The same applies to MR testing, reprocessing, and biocompatibility.

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

• Sample Size: Not explicitly stated in terms of the number of unique devices/tests in the provided text. The fatigue testing mentions "the proposed device performs as well as the reference devices (K213961, K241485)," implying a comparison and potentially new tests for the specific new TiBases. However, specific counts are not given.
• Data Provenance: The studies are non-clinical (laboratory tests) rather than human patient data. Therefore, "country of origin" and "retrospective/prospective" are not applicable in the context of patient data. The tests were performed to demonstrate compliance with international standards (ISO, ASTM) and FDA guidance.

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

• Not Applicable (N/A). This is a mechanical/material device clearance, not an AI/ML software evaluation based on expert-labeled data. The "ground truth" for these tests refers to the objective results conforming to engineering and material science standards (e.g., a device either fractures at a certain load or it doesn't, a material is biocompatible or not).

4. Adjudication method for the test set

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies in expert labeling for AI/ML ground truth, which is not relevant here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This is not an AI/ML software device that involves human interpretation of medical images.

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

• Not Applicable (N/A). This is a physical device, not an algorithm. The "software system verification" refers to confirming that the CAD/CAM software correctly integrates the design parameters for the physical components, not an AI algorithm's standalone diagnostic performance.

7. The type of ground truth used

• For mechanical (fatigue) testing: Compliance with ISO 14801:2016 and FDA guidance, meaning the physical behavior of the device under specified loads.
• For MR testing: Compliance with ASTM standards, meaning objective measurements of displacement, torque, and image artifacts.
• For software verification: Conformation that design parameters are correctly implemented in CAD/CAM software.
• For reprocessing and biocompatibility: Compliance with ISO standards and FDA guidance, meaning objective evaluations of sterility and biological response.

8. The sample size for the training set

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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

• Not Applicable (N/A). There is no AI/ML model involved; therefore, no training set.

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