(107 days)
Bonding all classes of direct composite restorations as well as for indirect procedures involving metal, porcelain, or composite crowns, inlays or onlays. The Angelus products multi-purpose systems also bond amalgam and self-cure composite can be used to bond orthodontic brackets to enamel.
The Fusion Single Link by Angelus is a versatile system for dental bonding. It is a onebottle adhesive system, indicated for restorations, adhesive cementation of indirect restorations (cast metal, porcelain and composite resin veneers) and intraradicular posts (cast metal and prefabricated in metal or fiber). It can also be used for the bonding of orthodontic brackets, and for the repair of porcelain restorations.
Here's a breakdown of the acceptance criteria and the study information for the Fusion Single Link device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device K962785 3M Dent System) | Reported Device Performance (Fusion Single Link) |
|---|---|---|
| Film thickness | ||
| Enamel adhesive layer | 6.40 (2.80) µm | 8.2 (2.40) µm |
| Dentin adhesive layer | 4.22 (1.25) µm | 8.4 (2.6) µm |
| Application Time | 57 seconds | 60 seconds |
| Light cure time | 10 seconds | 12 seconds |
| Bond to Dentin | 45 MPa | 37 MPa |
| Indications for Use | Bonding all classes of direct composite restorations, indirect procedures (metal, porcelain, composite crowns, inlays, onlays), amalgam, self-cure composite, orthodontic brackets to enamel, root desensitization. | Bonding all classes of direct composite restorations, indirect procedures (metal, porcelain, composite crowns, inlays, onlays), amalgam, self-cure composite, orthodontic brackets to enamel. |
Note: The document states that "Based on performance data according the ISO/TS 11405: 2003, it was found that the average strength and average resistance of the two devices are substantially equivalent." This implies that despite some numerical differences, the overall performance is considered comparable for the purpose of substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set. It mentions "performance data" according to ISO/TS 11405: 2003, but not specific numbers of samples or cases.
The data provenance is not specified beyond being "performance data according the ISO/TS 11405: 2003". It doesn't indicate country of origin or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study relies on standardized testing methods (ISO/TS 11405: 2003) to measure bond strength and other properties, rather than expert-established ground truth in a clinical or imaging context.
4. Adjudication Method for the Test Set
Not applicable as the study uses objective measurements based on ISO/TS 11405: 2003, not expert review or consensus for ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the new device to a predicate device based on material properties and bond strength, not on clinical interpretation or reading by human experts.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to the device described. The device is a dental adhesive, not an algorithm or AI system. The performance data presented refers to the physical and chemical properties of the adhesive itself.
7. Type of Ground Truth Used
The "ground truth" for this study is based on objective measurements of material properties and bond strength as defined by the ISO/TS 11405: 2003 standard. This standard provides guidelines for testing adhesion to tooth structure, including tensile and shear bond strength measurements.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set" in that sense. The study involves laboratory testing of material properties.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as points 8 explains.
§ 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.