(384 days)
The UltraEZ Desensitizing Gel provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. The product is used either by a dental professional in the dental office or provided to the patient for home treatment of dentin sensitivity.
Composed of potassium nitrate and fluoride ions in a film-like varnish. 3% Potassium Nitrate and 0.11% w/w Fluoride Ion Gel for the treatment of dentin sensitivity. For professional dental use. Immediate physical blockage of dentinal tubules to eliminate painful sensitivity. Designed to be used in a custom-fabricated dental tray.
The provided text describes a 510(k) premarket notification for a medical device called "UltraEZ Desensitizing Gel." This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical analysis.
Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, sample size for training set) are not applicable in this context because the submission is not a typical performance study as you might find for a diagnostic or AI-driven device.
Here's an analysis based on the provided document:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implicitly that the new device is as safe and effective as the predicate devices. The "performance" is demonstrated by showing similar composition and intended use.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (UltraEZ Desensitizing Gel) |
|---|---|
| Composition: Contains potassium nitrate and fluoride ions in a film-like varnish. | Composed of potassium nitrate and fluoride ions in a film-like varnish. (Matches predicates) |
| Potassium Nitrate & Fluoride Concentration: Similar concentrations to predicate devices. | 3% Potassium Nitrate and 0.11% w/w Fluoride Ion Gel. (Comparable to predicate's 3% Potassium Nitrate and 1200 ppm Fluoride Ion Gel, though exact numerical equivalence isn't stated for fluoride, it's considered functionally similar for efficacy.) |
| Intended Use: For professional dental use for treatment of dentin sensitivity. | For professional dental use for the treatment of dentin sensitivity. (Matches predicates) |
| Mechanism of Action: Provides immediate physical blockage of dentinal tubules to eliminate painful sensitivity. | Immediate physical blockage of dentinal tubules to eliminate painful sensitivity. (Matches predicates) |
| Indications for Use: Provides a film-like varnish for sensitive teeth, sealing dentinal tubules of over-exposed dentin and other exposed areas where post-operative or other dentin sensitivity is a concern. Used by dental professionals or for home treatment. | The UltraEZ Desensitizing Gel provides a film-like varnish... (Matches stated indications for use, which are consistent with predicate's function.) |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission relies on a comparison table of product characteristics with legally marketed predicate devices, not on a clinical test set. No data provenance is specified as a clinical study was not conducted or reported here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No ground truth was established by experts for a test set in this substantial equivalence submission. The "ground truth" is essentially the established safety and efficacy of the predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method was used for this type of submission.
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
- This is Not Applicable. This device is a dental product (desensitizing gel) and not an AI-driven or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" in a substantial equivalence filing is implied to be the established safety and effectiveness of the legally marketed predicate devices. The submission argues that because the new device is essentially the same in composition, indications, and mechanism as previously cleared devices, it also shares their safety and efficacy profile. No new ground truth data from clinical trials is typically required or presented for such filings unless safety or effectiveness questions are raised by the differences.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device; therefore, there is no training set.
9. How the ground truth for the training set was established
- Not Applicable. There is no training set as it's not an AI/machine learning 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.