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Dentium Prosthetics are intended for use as an aid in prosthetic rehabilitation.

Dentium Implantium and SuperLine Abutments are intended for use an aid in prosthetic rehabilitation. The abutments were originally cleared under 510(k) K041358. The modified designs proposed in this submission consist of the Angled Screw Abutment, Cover Screw, and Screw Abutment Cylinders. Abutments are supplied non-sterile and autoclaved by the end user.

This document describes the Dentium Implantium® and SuperLine® Abutments, which are dental abutments. The information provided focuses on the device's technical specifications and performance testing, rather than a study on an AI/ML-driven device with acceptance criteria typically associated with diagnostic algorithms.

Therefore, the requested information on acceptance criteria, reported device performance, sample sizes for test and training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable in the context of an AI/ML evaluation study.

The document discusses performance testing in a general device context, not related to an AI/ML algorithm's diagnostic accuracy. It uses "acceptance criteria" in the sense of the device meeting established specifications through bench testing and biocompatibility assessments, rather than diagnostic performance metrics like sensitivity or specificity.

Here's a breakdown of the available information, noting where the requested AI/ML specific details are not present:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a traditional medical device (dental abutments), the "acceptance criteria" are related to mechanical and biological performance, not diagnostic accuracy.

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

• Test Set Sample Size: Not specified in terms of number of cases/patients. The "test set" here refers to physical abutment samples used for bench testing.
• Data Provenance: Not applicable in the context of patient data. The testing was conducted on device samples.

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

• Number of Experts: Not applicable. Ground truth for dental abutment performance (e.g., fatigue failure) is established through standardized engineering tests, not expert interpretation of cases.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. Bench tests have objective Pass/Fail criteria based on physical and material properties.

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

• MRMC Study: No. This is not an AI/ML device.

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

• Standalone Performance Study: No. This is not an AI/ML device.

7. The type of ground truth used

• Type of Ground Truth: For biocompatibility, it's based on biological response to material samples (e.g., cell viability, immune reaction). For mechanical performance, it's based on physical failure thresholds and material integrity standards (e.g., absence of fracture after specified cycles, material composition specified by ASTM standards).

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires training data.

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

• Ground Truth for Training Set: Not applicable. This is not an AI/ML device.

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