(58 days)
Fusion Core is a high strength core material that offers the convenience of light curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resin/filler combination.
Fusion Core is a high strength core material that offers the convenience of fight curing with excellent depth of cure that allows either the layering or the core form approach to build-up. Fusion Core cuts just like dentin without clogging the cutting bur as many other BIS-GMA containing materials. Fusion Core contains no BIS-GMA and is based upon a hydrophilic resinffiller combination
The provided text is a 510(k) premarket notification for a dental material called "Fusion Core Material." It asserts substantial equivalence to predicate devices and describes the product's properties and intended use. However, it does not contain any information about acceptance criteria, device performance metrics, or any studies conducted to prove the device meets specific criteria.
Therefore, I cannot provide accurate information for the requested points. The document focuses on regulatory approval based on substantial equivalence, not on detailed performance studies or statistical evidence.
Specifically, the following information is not present in the provided text:
- A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are defined or reported.
- Sample sized used for the test set and the data provenance: No test sets or data provenance are mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
- Adjudication method: Not applicable as no test set evaluation is described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned. The document relies on substantial equivalence to existing dental materials.
- Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable, as this is a dental material, not a software algorithm.
- The type of ground truth used: No ground truth for performance is mentioned.
- The sample size for the training set: No training sets are mentioned.
- How the ground truth for the training set was established: No training sets or ground truth establishment are mentioned.
The document states: "The Fusion Core Material is substantially equivalent in design, composition, performance, intended use and effectiveness to the predicate kit products listed above." This statement, along with the quote from the NH Technology Assessment conference ("General usage of these materials over about 30 years indicates a high benefit-to-risk ratio... There is no evidence of short-term or long-term risk... There is no suspicion of any problems after virtually billions of procedures in the United States."), serves as the basis for the FDA's substantial equivalence determination, rather than a detailed, de novo study with specific performance metrics and acceptance criteria for this particular device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.