(59 days)
S&C Self Etch Primebond is intended for bonding composites, compomers, and resin modified glass ionomer cements to enamel and dentin.
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1. Acceptance Criteria and Reported Device Performance:
This document is a 510(k) clearance letter for a dental adhesive, not a study report. Therefore, it does not contain specific acceptance criteria or reported device performance metrics in the format of a table. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices. This implies that its performance, as demonstrated by the manufacturer, met the FDA's criteria for equivalence based on existing devices.
2. Sample Size for Test Set and Data Provenance:
Not applicable. This is a 510(k) clearance letter, not a clinical study report. Information regarding specific test set sample sizes or data provenance (country of origin, retrospective/prospective) for equivalence testing would have been part of the manufacturer's submission to the FDA, but is not detailed in this public document.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This document does not describe the establishment of a ground truth with experts. The "substantial equivalence" determination relies on comparisons to predicate devices, where performance data would have been submitted by the manufacturer.
4. Adjudication Method for Test Set:
Not applicable. This document is not a study report and does not describe an adjudication method for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This document is a regulatory approval letter for a dental adhesive. MRMC studies are typically used for diagnostic devices involving human interpretation of medical images.
6. Standalone Performance Study:
Not explicitly detailed. The 510(k) process involves the manufacturer providing data to demonstrate the device's safety and effectiveness (or substantial equivalence). While this would include in-vitro and potentially in-vivo testing, a "standalone algorithm only" performance study is not relevant for a physical dental adhesive product. The device itself is the "standalone" entity.
7. Type of Ground Truth Used:
Not directly specified in this document. For a dental adhesive, the "ground truth" used for demonstrating substantial equivalence would likely involve a combination of:
- Physical and Mechanical Property Testing: Adhesion strength, bond durability, wear resistance, etc., measured according to established standards.
- Biocompatibility Testing: To ensure the material is not harmful to tissues.
- Clinical Performance Data: If available and necessary, from studies demonstrating comparable clinical outcomes to predicate devices.
This document does not detail how the ground truth for these tests was established beyond the general presumption of adherence to relevant standards.
8. Sample Size for the Training Set:
Not applicable. This is a physical product (dental adhesive), not an AI or algorithm-based device that typically requires a "training set" in the computational sense. The product's formulation and manufacturing process would be developed and refined through R&D, but this isn't analogous to an algorithm's training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable for the reasons stated in point 8.
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.