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The Implantium abutments are intended to be used with the Implantium root-form endosseous dental implant to aid in prosthetic rehabilitation including overdenture retention. After the root-form endosseous dental implant is surgically placed, the endosseous dental implant abutment device is attached to it.

The Implantium abutments are devices made of pure titanium, titanium alloys, and plastic. The abutments in this 510(k) submission are supplemental to the previously cleared Implantium devices (K041368) and are designed to be used with the Implantium fixtures. These abutments are placed in the fixtures as a support for fitting prosthetic teeth. This submission includes four differently sized ball abutment kits for overdenture retention, and six different temporary abutments for placement of temporary restorations.

This 510(k) summary is for Dentium Inc.'s Implantium abutments and focuses on demonstrating substantial equivalence to predicate devices rather than presenting a clinical study with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.

Therefore, many of the requested details about acceptance criteria, study design, expert involvement, and ground truth establishment are not applicable or present in this document.

Here's an analysis based on the provided text, indicating "N/A" where information is not available:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size for Test Set: N/A (No specific test set or clinical study described for performance evaluation in this 510(k). Substantial equivalence is primarily based on material, design, and intended use comparison.)
• Data Provenance: N/A (No data provenance mentioned as it's not a clinical study.)

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

• Number of Experts: N/A
• Qualifications of Experts: N/A

4. Adjudication method for the test set

• Adjudication Method: N/A

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, and no MRMC study was performed.
• Effect Size: N/A

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

• Standalone Performance: No, this is not an AI/ML device.

7. The type of ground truth used

• Ground Truth Type: N/A (The "ground truth" here is the established safety and effectiveness of the predicate devices based on their prior clearance.)

8. The sample size for the training set

• Sample Size for Training Set: N/A (Not an AI/ML device; no training set.)

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

• Ground Truth Establishment for Training Set: N/A (Not an AI/ML device; no training set.)

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