(84 days)
Intended for: 1) treatment of hypersensitive teeth: 2) sealing the dentinal tubu es for cavity preparations or on sensitive root surfaces; and 3) a cavity liner.
FLUORIDE VARNISH coats a prepared tooth surface prior to placement of any restorative materials to prevent any of the restorative materials from pene rating into the dentinal tissue. FLUORIDE VARNISH contains releasable fluoride.
FLUORIDE VARNISH will be offered in unit dose vials with applicator brushes. Each vial contins material to treat 4-8 teeth, depending on their size.
This document is a 510(k) Summary for a medical device called "FLUORIDE VARNISH." It is a regulatory filing with the FDA, primarily focused on establishing substantial equivalence to previously marketed devices.
Based on the provided document, the device described is a Fluoride Varnish intended for dental use. The document focuses on regulatory approval based on substantial equivalence, not a study proving specific performance metrics against pre-defined acceptance criteria in the way an AI/ML device would.
Therefore, many of the requested elements (acceptance criteria, device performance table, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. This document aims to demonstrate that the new device is as safe and effective as existing legally marketed predicate devices, primarily through its components, intended use, and biocompatibility, not through a clinical performance study with quantitative acceptance criteria for predictive accuracy.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
Not applicable/Not present. This document is a 510(k) summary for a dental varnish, establishing substantial equivalence based on composition and intended use, not on quantitative performance metrics requiring specific acceptance criteria like an AI/ML diagnostic device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not present. This document does not describe a clinical performance study with a test set in the context of device performance metrics. Instead, it references biocompatibility testing and the prior use of components in legally marketed devices.
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)
Not applicable/Not present. This is not a diagnostic device requiring expert-established ground truth for performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not present.
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
Not applicable/Not present. This document does not describe an AI/ML device or a comparative effectiveness study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable/Not present. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to diagnostic performance studies is not directly relevant here. The "truth" in this context refers to the safety and effectiveness of the device based on its components, manufacturing, and intended use being comparable to predicate devices. The document states:
- "All of the components found in FLUORIDE VARNISH have been used in legally marketed devices or were found safe for dental use."
- "FLUORIDE VARNISH has been evaluated and passed biocompatibility testing for cytotoxicity, acute oral toxicity, irritation, and sensitization."
This suggests that the "ground truth" for proving safety and effectiveness relies on:
- Historical data and prior regulatory approvals of the individual components.
- Biocompatibility testing results (which serve as the "ground truth" for the device's biological safety).
8. The sample size for the training set
Not applicable/Not present. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established
Not applicable/Not present.
Summary of Device and Approval Process from the Document:
- Device Name: FLUORIDE VARNISH
- Manufacturer: DENTSPLY International
- Intended Use:
- Treatment of hypersensitive teeth
- Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces
- A cavity liner
- Predicate Devices: Duraphat Fluoride Varnish (K945794) and Duragard Fluoride Varnish (K002581)
- Approval Basis: Substantial equivalence to predicate devices, based on:
- Shared components with legally marketed devices.
- Biocompatibility testing (cytotoxicity, acute oral toxicity, irritation, sensitization).
- Performance data (though not detailed as quantitative metrics in this summary).
- Regulatory Decision: FDA determined the device is substantially equivalent to legally marketed predicate devices.
§ 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.