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The Select Components of the FRIALIT-2® Dental Implant System are indicated for use in the determination of implant placement, implant angle and to measure the available soft tissue height. The Select Components can also be used in determining the potential abutment angle and soft tissue height.

The FRIALIT-2 Select Components are part of the FRIALIT-2 Dental Implant System. The components consist if the FRIALIT-2 Select Sleeve, FRIALIT-2 Select Try-in Implant, and FRIALIT-2 Select try-in Abutment. The components come in the same diameters as the implant bodies and are color coded to correspond to size. The components can be used in the patient and/or the laboratory model to help in the determination of implant placement, abutment and implant angle and available soft tissue height.

This is a 510(k) premarket notification for a medical device, specifically dental implant components. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study demonstrating the device meets pre-defined acceptance criteria in the same way a de novo or PMA submission might. Therefore, many of the requested elements regarding acceptance criteria and a study to prove meeting them are not typically part of a 510(k) notification from this era.

Based on the provided text, here's what can be extracted:

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

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, and a "reported device performance" against those criteria, is not present in this 510(k) submission. A 510(k) primarily demonstrates substantial equivalence in design, material, and functionality to a predicate device.

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

Not applicable. This 510(k) submission does not describe a clinical study with a test set of data in the context of AI/software performance. It's a submission for physical dental components.

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)

Not applicable. As above, there is no study described that would involve establishing ground truth by experts for a test set.

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

Not applicable. There is no test set or adjudication process described.

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

Not applicable. This is not an AI/software device and no MRMC study is mentioned.

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

Not applicable. This is not an algorithm/software device.

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

Not applicable. The concept of "ground truth" as it relates to evaluating an algorithm's performance is not applicable to this submission for physical dental components. The "ground truth" in this context would be the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not applicable. There is no training set for an algorithm described.

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

Not applicable. There is no training set mentioned.

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