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Inclusive Titanium Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.
Inclusive Titanium Abutments are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes.

Inclusive Titanium Abutments are endosseous implant abutments which are placed into the dental implant to provide support for a prosthetic restoration. The abutment is placed over the implant shoulder and is mounted into the implant with a screw. Abutments and screws are made of titanium alloy (Ti-6AL-4V ELI) and meet ASTM F136 Standard. They are compatible with Straumann Standard Plus Tissue Level Implants in RN (4.1 mm and 4.8 mm) and WN (4.8 mm) sizes. Abutments are to be provided straight and are not intended for any angulation correction.

The provided text describes the submission for a 510(k) premarket notification for Inclusive® Titanium Abutments, compatible with Straumann® Standard Plus Tissue Level Implants. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study of the device's performance against specific acceptance criteria.

However, based on the non-clinical testing summary, we can infer the types of acceptance criteria and the nature of the study conducted.

Here's a breakdown of the requested information:

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

Since specific numerical acceptance criteria and performance metrics are not explicitly stated in this document (which is common for 510(k) summaries focusing on substantial equivalence), we'll infer them from the types of tests conducted and describe the reported outcome.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the document. The testing involved "finished assembled implant/abutment systems of the worst case scenario," but the number of samples is not provided.
• Data Provenance: Not specified, but likely conducted in a lab setting by or for Prismatik Dentalcraft, Inc. The document does not indicate country of origin or whether it was retrospective or prospective in a clinical sense, as it was non-clinical testing.

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)

• Number of Experts: Not applicable. This was non-clinical engineering and materials testing, not a study requiring human expert assessment for ground truth.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. This was non-clinical testing against predefined engineering standards and measurements, not a human reader study requiring adjudication.

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, an MRMC study was not done. This device is a dental implant abutment, not an AI diagnostic tool.

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

• Standalone Performance Study: Not applicable. This device is a physical medical device, not an algorithm.

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

• Type of Ground Truth: For the non-clinical testing, the "ground truth" would be established engineering standards, material specifications (e.g., ASTM F136 for titanium alloy), and the performance characteristics of the legally marketed predicate devices. The device's performance was compared against these established benchmarks.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a physical device, not an AI model, so there is no "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

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