(74 days)
5% Sodium Fluoride Varnish is indicated for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparations.
5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.
The provided document describes the 510(k) summary for "5% Sodium Fluoride Varnish." This is a medical device application for a product that is not software-based or AI-driven. Therefore, many of the requested categories in the prompt, such as "sample sizes for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set details," are not applicable.
The document focuses on demonstrating the substantial equivalence of the 5% Sodium Fluoride Varnish to a predicate device (Fluoride Varnish K031932) through non-clinical performance data and biocompatibility testing. No clinical performance data was considered necessary due to the low-risk nature of the device and commonality of materials.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Measured Performance) | Reported Device Performance (Conclusion) |
|---|---|
| Tubule Occlusion Efficacy | Demonstrated by in vitro bench testing. (Implies positive results without specific metrics provided). |
| Retention on the tooth surface | Tested, and the results support substantial equivalence to the predicate device. (Implies positive results without specific metrics provided). |
| Fluoride Release | Tested, and the results support substantial equivalence to the predicate device. (Implies positive results without specific metrics provided). |
| Fluoride Content | Tested, and the results support substantial equivalence to the predicate device. (Implies positive results without specific metrics provided). |
| Viscosity | Tested, and the results support substantial equivalence to the predicate device. (Implies positive results without specific metrics provided). |
| Stability | Tested, and the results support substantial equivalence to the predicate device. (Implies positive results without specific metrics provided). |
| Biocompatibility (Sensitization) | Determined to be non-sensitizing according to ISO 10993-1:2009. |
| Biocompatibility (Oral Mucosa Irritation) | Determined to be non-irritating with respect to requirements for Oral Mucosa Irritation according to ISO 10993-1:2009. |
| Biocompatibility (Cytotoxicity) | Determined to be equivalent to legally marketed varnish devices (predicate) according to ISO 10993-1:2009. |
| Risk Mitigation (ISO 14971:2007) | Risk analysis concluded that all device design controls and process controls will be able to mitigate known potential failures and effects. Performance testing and biocompatibility testing were also performed to mitigate other potential risks. |
| Technological Characteristics Similarity (to predicate K031932) | Both varnishes are viscous solutions with releasable fluoride in rosin bases dissolved by a solvent. Both can be applied to wet teeth and adhere upon contact with saliva. Both create a film that occludes dentin tubules for relief of hypersensitivity. |
| Safety and Effectiveness (compared to predicate K031932) | The data analyzed in various tests substantiate that 5% Sodium Fluoride Varnish is as safe and effective as the predicate Fluoride Varnish (K031932). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "non-clinical performance data included testing for tubule occlusion, viscosity, retention on the tooth surface, fluoride release and fluoride content." For biocompatibility, it states "Biocompatibility testing was performed according to ISO 10993-1:2009." Specific sample sizes for these tests are not provided in the summary.
- Data Provenance: Not specified, but generally, tests supporting a 510(k) submission are conducted in a controlled lab environment. This is considered a "bench test" or in vitro data.
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. This device is a fluoride varnish, and its performance is evaluated through physical, chemical, and biological testing (biocompatibility), not through expert interpretation of data like medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no human interpretation or ground truth establishment requiring adjudication for this type of device testing.
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. This is not an AI-assisted diagnostic or interpretative device; it's a topical dental product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. There is no algorithm or AI component to this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is established by the results of standardized in vitro bench tests that measure physical properties (viscosity, fluoride content/release, retention) and biological interaction (tubule occlusion efficacy, biocompatibility). These are objective measurements against established scientific standards.
8. The sample size for the training set
- Not applicable. There is no training set as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
§ 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.