(256 days)
For treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces.
Cervitec®F is a dental varnish for the treatment of dentinal hypersensitivity secondary to exposed dentin and root cervical surfaces. The varnish system is characterized by its good moisture tolerance during application. Cervited in either a Tube (4gm, 7gm) or Single Dose (0.26gm) delivery form.
The provided document describes the substantial equivalence of the Cervitec F dental varnish to its predicate devices, primarily Fluor Protector S (K131487), based on non-clinical performance testing and biocompatibility assessments. It does not contain information about a study proving the device meets acceptance criteria related to its clinical efficacy in treating dentinal hypersensitivity or exposed dentin and root cervical surfaces using metrics typically found in medical device studies (e.g., sensitivity, specificity, AUC).
Instead, the acceptance criteria and supporting study are focused on demonstrating that Cervitec F adheres to a relevant standard for fluoride varnishes and is biocompatible.
Here's a breakdown of the information available based on your request:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (from EN ISO 17730:2014) | Reported Device Performance (Cervitec® F) |
|---|---|
| Total fluoride content shall not deviate by more than 20% from the stated amount on the package. | Fulfilled. The product complies with the requirements as defined by ISO 17730:2014, including the total fluoride content criteria. |
| Other properties relevant for the device functioning or performing as intended (as per ISO 17730:2014). | "Specific physical properties have been assessed and verified according to product standard EN ISO 17730:2014 - Dentistry- fluoride varnishes." (Implied compliance) |
| Biocompatibility (as per EN ISO 10993-1:2009 and EN ISO 7405:2008) - Non-cytotoxic | Is neither cytotoxic. |
| Biocompatibility - Not of acute or subchronic systemic toxicity | Is not of acute or subchronic systemic toxicity. |
| Biocompatibility - Not genotoxic | Is not genotoxic. |
| Biocompatibility - Does not induce oral mucosal irritation | Does not induce oral mucosal irritation. |
| Biocompatibility - Low sensitization potential | Has a low sensitization potential. |
2. Sample size used for the test set and the data provenance:
- Non-clinical performance testing (ISO 17730:2014): Not explicitly stated. The document mentions "Specific physical properties have been assessed and verified," but details on the number of samples or methodology are not provided. These are generally laboratory tests on product batches.
- Biocompatibility testing: Not explicitly stated. Biocompatibility tests usually involve in vitro assays and in vivo animal studies, but the number of samples or subjects is not mentioned.
The provenance of this data is internal testing conducted by the manufacturer, Ivoclar Vivadent AG, to demonstrate compliance with international standards. It's retrospective in the sense that these tests were performed to support the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The "ground truth" for the non-clinical performance and biocompatibility refers to the established standards (ISO 17730:2014, EN ISO 10993-1:2009, EN ISO 7405:2008) themselves, and the device's adherence to their requirements as measured through laboratory and biological tests. There are no human "experts" establishing a clinical ground truth for image interpretation or diagnosis in this context.
4. Adjudication method for the test set:
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for diagnostic devices where human reader interpretations are compared. This document describes non-clinical and biocompatibility 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:
No. This type of study (MRMC, AI assistance) is not mentioned and is not relevant for a dental varnish approval for dentinal hypersensitivity. The device is a direct treatment, not a diagnostic or AI-powered assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual application dental varnish, not an algorithm.
7. The type of ground truth used:
- For non-clinical performance: The ground truth is defined by the specifications set out in the international standard EN ISO 17730:2014 "Dentistry – fluoride varnishes," particularly regarding the total fluoride content.
- For biocompatibility: The ground truth is established by the accepted scientific and regulatory principles for biocompatibility testing as outlined in EN ISO 10993-1:2009 and EN ISO 7405:2008, determining whether the material elicits an adverse biological response.
8. The sample size for the training set:
Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
Not applicable, as 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.