(8 days)
Flor-Opal Varnish White is a 5% sodium fluoride in a varnish carrier which produces a mechanical/chemical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Flor-Opal Varnish White is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier, delivered in a .5ml unit-dose syringe-to-syringe mixing system. A pleasantly flavored 5% neutral sodium fluoride in a varnish carrier for relief in dental hypersensitivity. 1ml of varnish contains 50mg of sodium fluoride in an alcohol and natural resin suspension. The varnish adheres well to a wet or dry tooth surface and is white in color when dry. It tolerates saliva, and food while occluding the dentinal tubules.
The provided document does not contain the acceptance criteria or results of a study as one would expect for a medical device's performance evaluation against specific metrics. Instead, it is a 510(k) summary for a Special 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study.
Here's why the requested information cannot be extracted from this document and what the document does communicate:
- Nature of the Submission: This is a Special 510(k) submission for Flor-Opal Varnish White. Special 510(k)s are typically used for modifications to a manufacturer's own legally marketed device where the modification does not affect the device's fundamental scientific technology or its intended use. The primary goal is to show the new device is substantially equivalent to the predicate device, not to prove performance against specific acceptance criteria in a clinical trial.
- Demonstration of Equivalence: The document achieves its objective by comparing the new device (Flor-Opal Varnish White) to its predicate (Flor-Opal Varnish K051750). The comparison focuses on:
- Intended Use: Same
- Type of Material: Same (Resin based)
- Human Factors: Same (Syringe-to-syringe mixing system)
- Biocompatibility/Safety: Same (Cytotoxicity testing passed for predicate, implied for new device)
- Characteristic Difference: The predicate is "Yellow-white color" while the new device is "White." This is the primary characteristic change highlighted.
Therefore, since this is a substantial equivalence (510(k)) submission and not a de novo clinical performance study, the document does not include the detailed performance evaluation against acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies that would be present in a traditional clinical study report.
However, I can extract the closest information available related to "acceptance criteria" and "study" as implied by a 510(k) context:
1. A table of acceptance criteria and the reported device performance
In the context of this 510(k), "acceptance criteria" relates to the properties that must be similar or equivalent to the predicate device. "Reported device performance" is largely expressed through the claim of "Same" or "passed."
| Property | Acceptance Criteria (Equivalence to Predicate) | Reported Device Performance (Flor-Opal Varnish White) |
|---|---|---|
| Intended Use | Must be the same as the predicate | Same |
| Type of material | Must be the same as the predicate (resin based) | Same |
| Human factors | Must be the same as the predicate (syringe-to-syringe mixing system) | Same |
| Biocompatibility/Safety | Must pass cytotoxicity testing and be safe/effective as per predicate | Same (as demonstrated by predicate testing) |
| Technological Characteristics | Must align with predicate's functional description (5% sodium fluoride, varnish carrier, etc.) | Aligns (flavored 5% neutral sodium fluoride in a varnish carrier) |
| Physical Appearance | (Characteristic difference noted) | White (vs. Yellow-white for predicate) |
| Internal Test Specifications (Lot Release) | Each lot must pass internal test specifications prior to release | Each lot of product must pass internal test specifications prior to release |
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 does not specify a sample size for a "test set" related to clinical performance. The comparison is based on the characteristics of the device itself and its equivalence to the predicate.
- The biocompatibility testing mentioned for the predicate (and by extension, the new device) is acknowledged, but the details of those tests (sample size, provenance) are not provided in this summary. It states "Cytotoxicity testing passed. Literature and testing to demonstrate product is safe when used as directed" for the predicate.
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 to this type of 510(k) submission. There was no clinical "test set" requiring expert ground truth in the traditional sense. The judgment of "substantial equivalence" is made by the FDA based on the provided technical and comparative data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable as there was no clinical "test set" and no adjudication process described for clinical outcomes.
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. This device is a dental varnish, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This device is a dental varnish, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the demonstration of substantial equivalence, the "ground truth" is primarily technical specifications and existing biocompatibility data of the predicate device. The change (color) is an observable physical characteristic. The ongoing safety and effectiveness are established by the predicate and the shared fundamental technology.
8. The sample size for the training set
- This information is not applicable. There is no "training set" as this is not an algorithm being developed.
9. How the ground truth for the training set was established
- This information is not applicable. There is no "training set."
In summary, the document details a Special 510(k) submission for a modified dental varnish, focusing on demonstrating substantial equivalence to a predicate device rather than presenting results from a clinical performance study with defined acceptance criteria and ground truth derived from expert review.
§ 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.