Search Results

AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel marqins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.

AuraVue is a clear pit and fissure sealant. Because this material is clear this allows observation of the tooth surface. AuraVue is color stable which allows the material to be indicative of conditions which may occur beneath the sealant. This would include possible leakage, staining and also allows the use of caries detecting devices. AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant. AuraVue is recommended for pit and fissure application and for minimally invasive dentistry. AuraVue is also recommended for sealing of composite enamel margins and as a composite sealer. AuraVue is available in both fluoride and non-fluoride releasing formulas.

The provided text is a 510(k) Premarket Notification for the AuraVue Pit & Fissure Sealant. It outlines the device's description, intended use, and comparison to predicate devices, and concludes with a letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices.

Crucially, this document is for a medical device (a pit and fissure sealant for dental use), not an AI/ML-driven diagnostic or medical imaging device. Therefore, the concepts of acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC studies, as typically applied to AI/ML device performance, are not relevant or described in this document.

The "study that proves the device meets the acceptance criteria" in this context refers to the demonstration of substantial equivalence to predicate devices, rather than a clinical trial with specific performance metrics against a defined ground truth as would be required for a novel AI/ML device.

Therefore, I cannot provide the requested information in the format specified because it is not contained within the provided document. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies (as there's no "AI" component to compare).
• Standalone algorithm performance (as it's a physical sealant).
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

Instead, the document focuses on demonstrating substantial equivalence to existing, legally marketed dental sealants. The safety and effectiveness are established by:

• Comparison of design, composition, and intended use to predicate devices (CosmeSeal Pit and Fissure Sealant, UltraSeal XT Pit and Fissure Sealant and Flowable Composite Kit, Delton Clear Pit and Fissure Sealant Kit).
• General usage history of similar materials: The document references a NIH Technology Assessment conference stating that "General usage of these materials over about 30 years indicates a high benefit-to-risk ratio...both composites and glass ionomers are relatively trouble-free. 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." This statement serves as a broad affirmation of the safety profile of the class of devices.
• Demonstrated clinical success as a sealant: The description mentions "AuraVue has excellent sealing ability and has demonstrated clinical success as a sealant," though specifics of this clinical success are not detailed in the provided text.

The FDA's letter confirms substantial equivalence, which is the regulatory pathway for this type of medical device, essentially meaning it is as safe and effective as a legally marketed predicate device.

Ask a specific question about this device