(116 days)
Enamelast™ Fluoride Varnish is 5% sodium fluoride in a varnish carrier which produces a mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.
Enamelast Fluoride Varnish is a flavored, xylitol-sweetened 5% sodium fluoride in a resin carrier delivered in a 0.4mL unit dose blister pack or in a 1.2mL syringe. Applicator brushes are provided with the 0.4mL unit dose blister. Delivery mechanisms are recommended in the instructions for use.
This document is a 510(k) Summary for a medical device called Enamelast™, a fluoride varnish. It aims to demonstrate substantial equivalence to a predicate device, Flor-Opal Varnish White.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device performance:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" for the device, but rather a "Substantial equivalence comparison" table (Table 7-1) that compares the characteristics of Enamelast™ with a predicate device (Flor-Opal Varnish White). This comparison implicitly serves to demonstrate that Enamelast™ meets performance standards similar to a legally marketed device.
Here's a reinterpretation of Table 7-1, focusing on characteristics that could be considered performance indicators:
| Characteristic | Acceptance Criteria (Implied by Predicate - Flor-Opal Varnish White) | Reported Device Performance (Enamelast™) |
|---|---|---|
| Intended Use | Treatment of tooth hypersensitivity via 5% sodium fluoride in varnish, mechanical/chemical occlusion of dentinal tubules. | Treatment of tooth hypersensitivity via 5% sodium fluoride in varnish, mechanical occlusion of dentinal tubules. |
| Intended User | Dental professional | Dental professional |
| Chemical Char. | 5% sodium fluoride, Resin based | 5% sodium fluoride, Resin based |
| Delivery System | Syringe-to-syringe mixing system with applicator tip | 1.2 mL pre-filled syringe; 0.4mL unit dose blister pack with applicator brush |
| Appearance | White resinous material | White resinous material |
| Odor | Bubble gum or Mint | Mint or Walterberry (strawberry/amaretto) |
| pH (Mint) | 2.95 | 3.9 |
| Shelf Life | 18 months | 24 months |
| Biocompatibility | Cytotoxicity (tested) | Cytotoxicity, Oral Mucosa Irritation, Genotoxicity, Sensitization (all tested) |
| Functional Testing | Film Thickness (tested) | Fluoride uptake, Fluoride varnish retention, Film Thickness (all tested) |
The document states, "The data supports the functionality of Enamelast." and "In summary, this submission demonstrates that Enamelast is substantially equivalent in safety and effectiveness and performs equivalently or better to the identified predicate and comparable product for its intended use."
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 mentions "In-house comparison testing has been performed on Enamelast, the predicate device, Flor-Opal Varnish White and OT Varnish 5% NaF." However, it does not provide any specific sample sizes for this testing.
The data provenance is stated as "In-house comparison testing," suggesting the tests were conducted by Ultradent Products, Inc. No information is given about the country of origin of the data or whether it was retrospective or prospective.
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 section is not applicable as the document describes a chemical/physical dental product, not an AI/diagnostic device that would require expert-established ground truth for a test set. The "ground truth" here would be the measured physical and chemical properties and biocompatibility results.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This is not applicable for the type of device and testing described. Adjudication methods like "2+1" typically apply to image interpretation or clinical diagnosis where multiple experts evaluate a case and resolve discrepancies. The testing described involves laboratory measurements of material properties and biocompatibility.
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 is not applicable. The device is a fluoride varnish, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance would not be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical product (fluoride varnish), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance would be derived from:
- Physical and Chemical Testing: Direct measurements of properties like pH, film thickness, fluoride uptake, and varnish retention.
- Biocompatibility Testing: Laboratory assays (e.g., cytotoxicity, oral mucosa irritation, genotoxicity, sensitization) according to established standards.
8. The sample size for the training set
This is not applicable. The device is a physical product, not a machine learning model that would require a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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.