(209 days)
ProLink: Direct Composite or Compomer restorations, Adhesive cementation, Composite repair. ProLink SE: Bonding of composites to tooth structure, Core Build up, Adhesive cementation of crown & bridges, including inlays and onlays.
ProLink is a 5th generation dentin/enamel single step bonding agent. The primer and adhesive are combined into a single component for ease of application. ProLink delivers outstanding shear bonding values to dentin, enamel & all popular light, dual or auto-cure composites. ProLink SE is a 7th generation light cured self etching dentin/enamel bonding agent. The etch, primer and adhesive are combined into a single component for ease of application. Separate conditioning (etching) of the enamel and dentine is not required.
The provided text describes the performance characteristics of the ProLink adhesives (ProLink, ProLink SE) and compares them to predicate devices. However, it does not include a table of acceptance criteria with specific numerical targets, nor does it detail a study that proves the device meets specific numerical acceptance criteria. Instead, it focuses on substantial equivalence to predicate devices based on general performance characteristics and physical tests.
Here's a breakdown of the information that is present and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as numerical targets. The document lists general performance characteristics expected from the device: "high bond strength," "a thin film thickness," "shelf stability," and "post placement stability." It does not provide threshold values for these characteristics.
- Reported Device Performance: No specific numerical performance values are reported for ProLink adhesives or the predicate devices. The study performed is described as "bench testing to evaluate the performance of the ProLink adhesives (ProLink, ProLink SE) compared to the following predicate devices." This implies a comparative study, but the results (e.g., specific shear bond strength values) are not included in this summary.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective) The document mentions "bench testing" but does not specify the sample size used for the test set, the country of origin of the data, or whether it was retrospective or prospective.
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) This information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set This information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses.
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 This information is not applicable and hence not provided as the study involves bench testing of material properties, not human interpretation of medical images or diagnoses or AI systems.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done This information is not applicable and hence not provided as the study involves bench testing of material properties, not AI or algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Ground truth is established by the bench test measurements themselves (e.g., shear bond strength, marginal integrity). This is a direct measurement of the material's physical properties.
8. The sample size for the training set This information is not applicable and hence not provided as there is no mention of a "training set" as this is not an AI/machine learning study.
9. How the ground truth for the training set was established This information is not applicable and hence not provided as there is no mention of a "training set" or AI/machine learning.
Summary of the Study Mentioned:
- Study Type: Bench testing.
- Purpose: To evaluate the performance of ProLink adhesives (ProLink, ProLink SE) compared to four predicate devices: Adper Single Bond Plus, iBond Total Etch, G-Bond, and Clearfil Tri-S Bond.
- Properties Evaluated:
- Shear Bond strength to etched enamel and to etched dentin
- Marginal integrity
- Conclusion: The submission concludes that ProLink Adhesives are "safe and effective and substantially equivalent to the predicate devices described herein" based on intended use, indications for use, composition, physical properties, and technological characteristics. The results of the bench testing (e.g., specific bond strength values) are not reported in this summary, only that such tests were conducted for comparison to predicate devices. The basis for equivalence relies on similar technological characteristics (e.g., photoinitiator system, resin matrix, fillers, hybrid zone formation, hydrophilicity) and the assumption that if the technological characteristics are similar and the performance tests were conducted, then the new device performs comparably to the legally marketed predicates.
§ 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.