(94 days)
The Acquaseal Benz is indicated for dental restorative, hypersensitivity, cervical, and hygiene procedures.
Hydrophilic liquid containing Hydroxyethyl- methacrylate (HEMA), Fluoride and Benzakonium Fluoride.
The provided document is a 510(k) Pre-Market Notification for a dental bonding agent called "Acquaseal Benz". It aims to establish substantial equivalence to a predicate device, "Hema-Benz" (K953405).
This document does NOT contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in the context of typical AI/software device evaluation.
Instead, it focuses on demonstrating that the new device ("Acquaseal Benz") is substantially equivalent to an existing, legally marketed device ("Hema-Benz") based on its intended use, technological characteristics, and descriptive information (ingredients, purpose, properties). This is a regulatory pathway that often does not require new clinical studies if substantial equivalence can be shown through comparison with a predicate device.
Therefore, for almost all the requested information, the answer will be that the document does not provide it, as those types of studies and criteria are typically associated with novel devices or devices where substantial equivalence cannot be established through comparison alone.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., bond strength, desensitization efficacy rates, durability scores) from a dedicated study. The "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, meaning the new device is expected to perform at a comparable level to the predicate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable - This document establishes substantial equivalence, which implies comparable performance to the predicate device without specifying quantitative criteria for the new device's independent performance. | Not applicable - No specific performance metrics for Acquaseal Benz are reported from an independent study in this document. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. The document is a 510(k) pre-market notification based on comparison to a predicate device, not a report of a new clinical study with a test set of data.
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. The document does not describe a study involving a test set that required expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication method 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 not an AI/software device, and no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no new study requiring independent ground truth establishment described in this document. The "ground truth" for regulatory purposes here is the established safety and effectiveness of the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/software device and no training set is mentioned.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/software device and no training set is mentioned.
§ 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.