(89 days)
Pulpdent VARNISH I, II, III, and IV are desensitizing cavity varnishes and dentinal tubule sealers. They are indicated for exposed sensitive dentin or cementum after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements, minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluid flow by sealing the dentinal tubules and producing a physiologic barrier. Pulpdent VARNISH is used by the dental professional to control thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulpdent VARNISH can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.
Pulpdent VARNISH I, II, III and IV are mixtures of either copal resin or polyamide resin and strontium chloride in organic solvent. The formulas for Varnish III and IV also contain the surfactant, cetyl pyridinium chloride.
This document is a 510(k) premarket notification for a dental device, "PULPDENT CAVITY VARNISH," submitted to the FDA in 1998. It does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/software device submission would. Instead, it relies on the concept of "substantial equivalence" to predicate devices.
Therefore, for aspects of your request that pertain to modern AI/software device evaluation (like sample sizes for test/training sets, expert ground truthing, MRMC studies, or standalone performance), the document provides no relevant information.
Here's how the available information maps to your request:
1. A table of acceptance criteria and the reported device performance:
This document describes safety and effectiveness in terms of historical use and substantial equivalence, not specific quantitative acceptance criteria or performance metrics derived from a study.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: | "effective and safe over about twenty years of experience" |
| "no evidence of short or long term risk or suspicion of any problems after literally billions of procedures in the United States." | |
| Effectiveness: | Defined by meeting the intended use as a "desensitizing cavity varnish and dentinal tubule sealer" with functions like protecting dentin/pulp, reducing acid diffusion, minimizing marginal leaks, acting as a thermal insulator, and controlling dentinal fluid flow. |
| Supported by reference to "scientific and clinical literature" and "substantial equivalence" to predicate devices. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No test set or associated data provenance is described. The submission relies on "substantial equivalence" and historical literature.
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. No ground truth establishment for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No test set adjudication is described.
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 a non-AI dental varnish, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a non-AI dental varnish.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The closest concept to "ground truth" here is the historical scientific and clinical literature, which provides evidence for the safety and effectiveness of cavity varnishes of similar composition over time, and the implicitly accepted "ground truth" that the predicate devices are safe and effective for their intended uses. This is a regulatory "ground truth" by precedent rather than a specific study's ground truth.
8. The sample size for the training set:
Not applicable. There is no training set for an algorithm described.
9. How the ground truth for the training set was established:
Not applicable. There is no training set or associated ground truth establishment described.
§ 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.