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The Link Abutment for CEREC is titanium alloy abutments placed onto HIOSSEN dental implants to provide support for customized prosthetic restorations. Link Abutment for CEREC is indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
• Link abutment for CEREC
All digitally designed copings and/or crowns for use with the Link abutment for CEREC is to be scanned using Sirona CEREC AC or CEREC AF or CEREC AI, designed using Sirona inLab software (Version 3.65) or Sirona CEREC Software (Version 4.2) and manufactured using a Sirona CEREC or inLab MC X or MC XL milling unit. CAD/CAM manufacturing/milling occurs at dental laboratories per the design limitations of the Sirona CEREC.

The Link Abutment for CEREC provide the interface for mesostructure designed and milled using the Sirona CEREC system with HIOSSEN Implant System (K140934) The Link Abutment for CEREC is pre-manufactured (stock) abutment made from a titanium alloy (ASTM F 136). The Link Abutment for Cerec is a Ti-base abutment design consisting of the Link Abutment and Sirona ceramic mesostructure. The coronal portion is designed to interface with the pre-machined mounting hole in the milling blanks compatible with the Sirona CEREC MC X and MC XL prosthetic milling systems.

This document is a 510(k) premarket notification for a dental device, the "Link Abutment for CEREC." It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study for acceptance criteria of an AI/ML device. Therefore, much of the requested information regarding AI/ML device performance and ground truth establishment is not available in this document.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present "acceptance criteria" in the typical sense of metrics for an AI/ML device. Instead, it demonstrates substantial equivalence through comparisons of design, materials, indications for use, and non-clinical testing. The "reported device performance" is primarily in the context of mechanical properties and safety.

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

• This document describes non-clinical performance testing (fatigue, sterilization) of a physical dental device, not an AI/ML algorithm. Therefore, there isn't a "test set" of data in the AI/ML sense. The "sample size" would refer to the number of physical abutment samples tested. This specific number is not provided in the document, but it states "fatigue testing was considered... with the worst case scenario."
• Data provenance: Not applicable in the AI/ML context. The document refers to testing of the physical medical device and reference to predicate devices. The manufacturer is OSSTEM Implant Co., Ltd. from Busan, Republic of Korea.

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

• Not applicable as this is not an AI/ML device study. Ground truth, in this context, would relate to the established engineering standards and specifications for dental abutments.

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

• Not applicable as this is not an AI/ML device study. Adjudication methods are relevant for resolving discrepancies in expert labeling or diagnoses for AI/ML ground truth.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done because this is a physical dental abutment, not an AI/ML diagnostic or assistive device.

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

• No, a standalone algorithm performance study was not done because this is a physical dental abutment, not an AI/ML algorithm.

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

• The "ground truth" for this device's safety and effectiveness relies on established engineering principles, material science standards (e.g., ASTM F 136 for titanium alloy, ISO 17665-1:2006 for sterilization), and comparison to predicate devices that have already demonstrated safety and effectiveness through their prior clearances (K120847, K151324). It's essentially a demonstration of conformance to pre-defined physical and mechanical properties and established clinical use for dental abutments.

8. The sample size for the training set

• Not applicable as this is not an AI/ML device and therefore does not have a training set.

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

• Not applicable as this is not an AI/ML device and therefore does not have a training set.

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