(62 days)
Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.
Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)
Acceptance Criteria and Device Performance for Dentinal Tubuli Seal:
Based on the provided documents, it is not possible to extract specific quantitative acceptance criteria or detailed study results for the Dentinal Tubuli Seal. The documents are a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence in terms of indications for use, technological characteristics, and safety and effectiveness, rather than meeting specific pre-defined quantitative performance metrics in a new clinical study.
Therefore, the following sections will indicate "Not Applicable" or "Not Provided" where the requested information is not present in the given FDA letter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Indications for Use | Sealing cavities before restorations; Barrier against irritants from cements/restorative materials; Reduces penetration of oral fluids at restoration-tooth interface into dentin; Minimizes postoperative sensitivity when applied to dentinal surfaces under new restorations. | Device is recognized as substantially equivalent for these indications for use. Specific performance metrics are not detailed in this document. |
| Technological Characteristics | (Implied: Similar to predicate device) | (Implied: Similar to predicate device) |
| Safety and Effectiveness | (Implied: Equivalent to predicate device) | (Implied: Equivalent to predicate device) |
| Quantitative Performance | Not specified in the provided document. | Not specified in the provided document. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not provided in the document. 510(k) clearance often relies on existing data from the predicate device and potentially product specifications rather than a new standalone clinical test set.
- Data Provenance: Not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not provided in the document.
- Qualifications of Experts: Not provided in the document.
4. Adjudication method for the test set:
- Adjudication Method: Not provided in the document.
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:
- MRMC Study: Not applicable. This device is a cavity varnish, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This device is a physical product (cavity varnish), not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: Not explicitly stated. For a 510(k) submission of a cavity varnish, ground truth would typically be established based on accepted dental practices, material science principles, and existing clinical data or performance data of the predicate device, rather than patient outcomes or pathology from a new study.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device is a physical product, and the concept of a "training set" as understood in machine learning/AI does not apply.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable. The concept of a "training set" does not apply to this 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.