(79 days)
OptiBond Solo Plus 3 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, and post cementation.
The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials and fissure sealant, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.
This is a medical device application for a pit and fissure sealant (OptiBond Solo Plus 3), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study details, ground truth, or sample sizes related to AI/ML device performance. The document is a 510(k) summary for a traditional medical device demonstrating substantial equivalence to a predicate device.
To answer your request, if this were an AI/ML device, the following information would typically be required but is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| (Not Applicable - No AI/ML device) | (Not Applicable) | (Not Applicable) |
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: Not applicable.
- Data Provenance: Not applicable.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Not applicable.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? Not applicable.
- Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.
6. Standalone Performance Study
- Was a standalone study done? Not applicable.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable.
8. Sample Size for Training Set
- Sample Size for Training Set: Not applicable.
9. How Ground Truth for Training Set Was Established
- How Ground Truth for Training Set was established: Not applicable.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.