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The Conometric Abutments are intended to be used in conjunction with the Conometric Final Cap and Ankylos C/X implants, OsseoSpeed EV implants and Xive S implants to support fixed friction retained single or maxilla, in a partially or completely edentulous patient. This system is intended for delayed loading. The Conometric Abutment including the abutment screw and the Conometric Final abutment. The abutment. The abutment screw is intended to secure the abutment to the endosseous implant.

The proposed Conometric Abutments are intended for use by dental clinicians in the support of prosthetic dental restorations. The conometric concept provides conical friction retention for fixed single tooth restorations. The Conometric Abutments are provided together with prosthetic conometric caps, impression laboratory devices, and insertion and fixation instruments. The abutments are provided with an angulation of 0° and 15° at gingival heights of 1.5, 3.0 and 4.5 mm for Ankylos® Conometric Abutments and with 1.0, 2.0 and 3.0 mm for Xive® and Astra Tech Implant System EV® Conometric Abutments. They are manufactured of Titanium Alloy. The Conometric Final Caps are to be cemented into the final crown to provide friction retention to the abutment. They are made of gold-shaded titanium and are available in the diameter of 3.3 and 4.5 mm. The Conometric Temporization Caps provide support of immediate and short term provisional prosthetic restorations on Conometric Abutments up to 6 months. The temporary caps are provided with the diameter 3.3 mm and 4.5 mm and are manufactured of PEEK material. The smaller cap (Ø 3.3 mm) also contains titanium alloy. The Conometric Healing Caps protect the Conometric Abutment until a crown is placed and serve for the shaping of the gingiva. The Healing Caps are made of PEEK polymer and available with an diameter of 3.3 mm and 4.5 mm. Regarding the outer geometries, the Healing Caps are presented as a wide variant with an maximum outer diameter of 6.0 mm and - for the Healing Cap Ø 3.3 mm - also as a small version with an maximum outer diameter of 4.8 mm.

This document is a 510(k) premarket notification for Dentsply Sirona's Conometric Abutments. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data.

Here's a breakdown of the requested 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 (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes for the test sets in the non-clinical performance studies (Fatigue Testing, Pull-out Test, Dynamic Load Testing for Friction Retention). It generally refers to "worst-case construct" and "implants," implying specific setups for testing but not the number of units tested.

The data provenance is internal testing performed by Dentsply Sirona or its subsidiaries, as implied by the submission document. The country of origin of the data is not explicitly stated. The studies are prospective bench tests, not studies involving patients or real-world data.

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)

This information is not applicable as the studies are entirely non-clinical bench tests. There is no human interpretation of medical images or expert consensus required to establish ground truth for mechanical, material, or sterilization performance. The ground truth is defined by the objective measurement of physical properties against established engineering and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the studies are entirely non-clinical bench tests. Adjudication methods are typically used in clinical studies or studies involving expert interpretation where there might be disagreement in assessing outcomes.

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 MRMC study was done. This device is a dental implant abutment, a physical medical device, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable. The device is a physical medical device; there is no algorithm or AI component.

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

The ground truth for the non-clinical studies is based on established engineering standards (e.g., ISO 14801, ISO 10993, ISO 11137, ISO 17665) and objective measurements of physical and mechanical properties. For example:

• Fatigue Testing: Ground truth is defined by the device's ability to withstand dynamic loads without failure, as per ISO 14801.
• Pull-out and Friction Retention Tests: Ground truth is defined by the measured forces/torques being within an acceptable performance range considered safe and effective for dental abutments.
• Biocompatibility: Ground truth is defined by the material's conformity to biological safety standards (e.g., cell viability in cytotoxicity tests).
• Sterilization: Ground truth is defined by achieving a specific Sterility Assurance Level (SAL) per ISO standards.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI or machine learning model that requires a training set.

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

This information is not applicable for the same reason as above.

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