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-Bonding of all direct composite restorations
-Bonding of dual/self cure composite and core build-ups
-Repairs of composite fillings
-Root surface desensitization

K-Bond Universal is a bonding system that offers exceptional bonding strength through a convenient single bottle application. This single-component bonding agent is specifically formulated to effectively bond various types of direct composite restorations to dentin, enamel, as well as composite.

The provided text describes the regulatory clearance of a dental bonding agent, K-Bond Universal, and not an AI/ML powered medical device. Therefore, information regarding acceptance criteria and studies for AI/ML devices, such as sample size for test/training sets, expert qualifications, and details about MRMC studies, is not present.

However, I can extract information related to the performance testing described for the K-Bond Universal device:

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (implied to be laboratory testing of the device and predicate).

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 a material performance test, not a diagnostic device requiring expert opinion for ground truth.

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

• Not applicable. Performance was measured against ISO standards and internal requirements.

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/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Performance criteria based on ISO 29022 standard for shear bond testing and internal requirements (for dentin and enamel shear bond strength).
• For root surface desensitization, the ground truth was established by confirming dentin tubule blockage.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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