(72 days)
Desensitizing agent for dentin surfaces by occluding dentin tubules to help prevent microleakage. Use under direct or indirect restorations following dentin etch and province dentin adhesive application. Desensitizing agent for use in treatment of cervical erosion in Class V restorations.
AdPharma™ Occlude® Dentin Tubule Agents are for use in one of a number of steps normally involved in the restoration of teeth. This device comes into use following the dentin-etching step and prior to the application of a dentin adhesive or adhesive/primer. The Occlude® is applied to the exposed dentin and the solvent evaporated off, leaving the active glass. It is also anticipated to market Occlude® Dentin Tubule Agents combined with a commercially available, non-aqueous dentin adhesive to condense these two application steps into one step. In vitro testing indicated this combination version is still efficacious. The Occlude® is manufactured in such a way that it is intended to enter the exposed dentin tubules and penetrate to a greater depth than the adhesive itself or adhesive/primer itself.
The provided text describes a 510(k) summary for the AdPharma™ Occlude® Dentin Tubule Agent. This is a dental device, and the evaluation for such devices typically involves bench testing for physical properties rather than clinical studies with human participants assessing diagnostic accuracy or comparative effectiveness with AI. Therefore, many of the requested points related to AI, human readers, and ground truth established by experts are not applicable here.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Micro-leakage reduction | Should reduce micro-leakage | "demonstrates Occlude® Dentin Tubule Agents work for their intended use of reducing micro-leakage" |
| Bond strength | Should not adversely affect bond strength | "demonstrate that Occlude® Dentin Tubule Agents do not exhibit adverse affects on bond strengths" |
| Biocompatibility | Safe for use in body | "biocompatibility assessment was completed for the Occlude® Dentin Tubule Agents indicating them to be safe for use in body" |
Note: The document does not provide specific quantitative acceptance criteria or numerical results for these performance metrics. The descriptions are qualitative confirmations of meeting the intended function.
2. Sample size used for the test set and the data provenance
The document mentions "Bench testing" which typically involves laboratory-based experiments on materials or simulated conditions. It does not specify the sample size for these tests. The data provenance is "in vitro testing" performed for the purpose of this 510(k) submission. No country of origin for the data is mentioned beyond AdPharma being a USA corporate office. These tests would be retrospective in the sense that they were completed before the filing, but prospective in terms of being designed for the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this type of device is established through an objective measurement of physical properties (e.g., micro-leakage, bond strength) rather than expert interpretation of images or clinical outcomes.
4. Adjudication method for the test set
Not applicable, as the evaluation is based on objective bench testing, not expert adjudication of subjective assessments.
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 not an AI-powered diagnostic device, 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 not an AI algorithm.
7. The type of ground truth used
The ground truth was based on objective measurements from bench testing for properties like micro-leakage and bond strength, and a biocompatibility assessment.
8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.