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510(k) Data Aggregation
(169 days)
Rennou™ Varnish is indicated for the relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules.
Rennou™ Varnish is a cavity varnish intended for professional use as a topical application on prepared tooth surfaces. This fluoride-free varnish creates a rosin-based film that prevents penetration of restorative material into the dentinal tissue and provides relief of tooth hypersensitivity by occluding open dentinal tubules. Unit-dose varnish and applicator are packaged together in individual thin, sealed trays. Rennou™ Varnish is only applied by a professional clinician.
Rennou™ Varnish is a topically applied flavored (Spearmint, etc.) compound comprised of natural rosin, ethanol, xylitol, and Rennou™ (a combination of theobromine, calcium acetate, and sodium hydrogen phosphate). The major components are rosin and ethanol, which, when delivered together, efficiently promote a fast-drying film on the tooth surface. The varnish is sweetened with xylitol.
The provided document is an FDA 510(k) clearance letter for Rennou™ Varnish. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria in a quantitative manner typical of an AI/software device.
A 510(k) submission primarily shows that a new device is as safe and effective as a legally marketed predicate device. While "testing summary" is mentioned, it refers to laboratory studies, not a clinical trial with human subjects and specific performance metrics like sensitivity, specificity, or accuracy compared to ground truth.
Therefore, many of the requested elements for an AI/software device performance study are not applicable or cannot be extracted from this document, as Rennou™ Varnish is a physical medical device (cavity varnish), not an AI/software device.
Here's an analysis based on the information provided, highlighting the differences:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not specify quantitative "acceptance criteria" in the way an AI/software device would (e.g., minimum sensitivity of 90%). Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device in terms of:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Premarket Notification (510(k)) Criteria | |
| Identity: Be substantially equivalent in indications for use, technological characteristics, and safety and effectiveness. | Concluded to be substantially equivalent to predicate device: Colgate® Prevident Varnish (K132109). |
| Similar Indications for Use | Rennou™ Varnish indicated for "relief of tooth hypersensitivity through the mechanical occlusion of dentinal tubules." This is consistent with the primary predicate and reference devices. |
| Similar Product Design | Cavity varnish product design is the same as the primary predicate device. |
| Similar Technological Characteristics | Provides prolonged contact of ingredients with tooth surface; forms protective barrier; releases minerals to enhance tooth structure. Biocompatible. Consistent with primary predicate and other reference devices. |
| Safety - Biocompatibility | Cytotoxicity testing per ISO 10993-5 and USP showed acceptable biocompatibility. Exhibited a slightly more favorable safety profile than the primary predicate. |
| Effectiveness - Tubule Occlusion & Enamel Protection | Enamel protection and dentinal hypersensitivity tests on molars and dentin specimens showed effective tubule occlusion, deep penetration, and a smooth surface finish, confirmed by SEM analysis. |
| Risk Analysis | Comprehensive risk analysis revealed no new questions of safety or effectiveness. |
2. Sample Size for Test Set and Data Provenance
This information is not provided in the document. The "tests" mentioned are general laboratory studies ("Comprehensive laboratory studies evaluated Rennou™ Varnish for performance and biocompatibility. Enamel protection and dentinal hypersensitivity tests on molars and dentin specimens..."). There is no mention of a "test set" in the context of an AI/software device's performance evaluation against a defined ground truth.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This device is a physical product, not an AI/software diagnostic or assistive tool where expert-established ground truth is typically used for performance evaluation.
4. Adjudication Method
Not applicable for a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/software device designed to assist human readers.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a physical product, not an algorithm. The laboratory studies focused on the physical properties and biological interactions of the varnish itself.
7. Type of Ground Truth Used
For the laboratory studies:
- Physical/Biological Measurements: SEM analysis for tubule occlusion, deep penetration, smooth surface finish.
- Biocompatibility Standards: ISO 10993-5 and USP for cytotoxicity.
These are objective measurements and established standards, rather than "ground truth" derived from expert consensus or pathology in the context of diagnostic AI.
8. Sample Size for Training Set
Not applicable for a physical medical device. There is no "training set" in the context of machine learning.
9. How Ground Truth for Training Set Was Established
Not applicable.
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