(66 days)
Activ Varnish is a resin-based varnish, containing 17% Xylitol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions.
Activ Varnish is a resin-based varnish, containing 17% Xyliol and less than 20% ethanol, that is applied to enamel or dentin for professional treatment of dental hypersensitivity. Activ Varnish treats hypersensitivity by releasing fluoride, calcium and phosphorus ions that precipitate on and, thereby, occlude dentinal tubules and fill superficial, non-carious enamel lesions. Activ Vamish is available in unit-dose and bulk packaging.
This submission is a 510(k) premarket notification for a dental varnish. 510(k)s demonstrate substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with acceptance criteria. Therefore, the information typically requested regarding acceptance criteria and detailed study specifications is not present in this document.
Here's a breakdown of the available information regarding "safety and effectiveness" as presented in this 510(k) summary:
The document states:
"SAFETY AND EFFECTIVENESS: Activ Varnish is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products listed above that have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems."
Based on this statement, there is no specific study described that proves the device meets explicit acceptance criteria in the manner of a clinical trial. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices that have a long history of safe and effective use.
Here's why the specific points you requested are not applicable or cannot be answered from this 510(k) submission:
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A table of acceptance criteria and the reported device performance: Not applicable. There is no such table because this is a substantial equivalence claim, not a new clinical study with predefined acceptance criteria. The "performance" is considered equivalent to the predicate devices.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or clinical data is presented for Activ Varnish to demonstrate performance against specific criteria. The safety and effectiveness are inferred from the predicate devices' history.
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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): Not applicable. No test set, no ground truth establishment in this context.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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: Not applicable. This is a dental material, not an AI or imaging device involving human readers.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a dental material, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for the substantial equivalence claim resides in the predicate devices' established safety and effectiveness over 15+ years.
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The sample size for the training set: Not applicable. This is not an AI/machine learning device.
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How the ground truth for the training set was established: Not applicable.
In summary: The document establishes the safety and effectiveness of Activ Varnish by asserting its substantial equivalence to existing, legally marketed predicate devices with a proven track record of safe and effective use over many years. This type of submission relies on comparisons of design, composition, performance, and intended use, rather than de novo clinical studies with specific performance metrics and acceptance criteria.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.