(296 days)
For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces
V-varnish™ Premium is cavity varnish containing 5% sodium fluoride(F ion: 22,600ppm). It is applied to teeth for the purpose of treatment dentinal hypersensitivity. V-varnish™ Premium consists of rosin which adheres to the surface of the teeth, seals exposed dentin tubules. V-varnish™ Premium has four flavors such as bubblegum, strawberry, melon and mint and two colors(clear and white). It is packed in single dose package allows easy mixing and application.
The provided document is a 510(k) summary for V-varnish™ Premium, a cavity varnish. It details a comparison study against a predicate device, Enamel Pro® Varnish (K062683). The study is for the purpose of demonstrating substantial equivalence, not conducting a comparative effectiveness study in the typical sense of human reader performance.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on demonstrating that the V-varnish™ Premium's physical and performance properties are "substantially equivalent" to the predicate device, Enamel Pro® Varnish. The values for the predicate device serve as the de facto "acceptance criteria" against which the new device's performance is measured.
| Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (V-varnish™ Premium) |
|---|---|
| Consistency: $33.25\pm0.64$ mm | Consistency: $27.14\pm0.62$ mm |
| pH: 6.69 | pH: 6.65 |
| Fluoride content: $1.97\pm0.05$ % | Fluoride content: $2.15\pm0.03$ % |
| Dentinal tubule occlusion: 77% | Dentinal tubule occlusion: 85% |
| Biocompatible when used as directed per ISO 10993-1 | Meets ISO 10993 requirements for cytotoxicity, genotoxicity, oral mucous irritation, sensitization (LLNA), acute systemic toxicity |
| Shelf Life: 2 years | Shelf Life: 2 years |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the "in vitro" tests (consistency, pH, fluoride content, dentinal tubule occlusion). It also does not specify the provenance (country of origin, retrospective/prospective) of the data for these tests. However, the tests were conducted in vitro using the devices themselves.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This type of study does not involve expert readers establishing ground truth as it is a bench study evaluating physical and chemical properties, and biocompatibility, of a dental varnish.
4. Adjudication Method for the Test Set
Not applicable for a bench study of physical and chemical properties and biocompatibility.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) premarket notification for a medical device (cavity varnish), which relies on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing rather than human reader studies. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device (cavity varnish), not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" for the non-clinical performance tests are the measured physical and chemical properties of the devices themselves, as determined by laboratory testing. For biocompatibility, the ground truth is adherence to internationally recognized standards (ISO 10993 series).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning study that requires a training set. The study involves bench testing of a physical product.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
§ 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.