(192 days)
Remesense is intended for the local management of dental sensitivity by patient application of foam strips impregnated with desensitizing gel.
Remesense is indicated for use as a tooth desensitizer.
Remesense consists of a tray and impregnated foam strips. The Remesense foam strips are thin flexible foam strips, impregnated with a desensitizing liquid. These strips are designed to relieve dental (hyper) sensitivity by patient application to the affected tooth (teeth). The impregnated foam strips are held in place with trays.
Here's an analysis of the provided text regarding the Remesense device, focusing on the acceptance criteria and study information:
The provided 510(k) summary for K082594 for the Remesense device does not contain any information about acceptance criteria or a study proving the device meets those criteria.
This is a common characteristic of 510(k) submissions for devices seeking substantial equivalence to a predicate device. The primary objective of these submissions is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than to prove its performance against specific acceptance criteria through a clinical or performance study.
Therefore, many of the requested elements for a study design and results cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Feature | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Any device-specific performance metric for desensitization | Not provided | Not provided |
Explanation: The document does not specify any quantitative or qualitative acceptance criteria related to the device's efficacy in tooth desensitization, nor does it report any performance data from a study against such criteria. The submission is focused on demonstrating substantial equivalence based on technological characteristics and intended use.
Regarding the Study (if one were present):
Since no specific study proving the device meets acceptance criteria is described, the following points cannot be addressed from the provided text:
2. Sample size used for the test set and the data provenance: Not applicable, no study described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, no study described.
4. Adjudication method for the test set: Not applicable, no study 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 device is a dental product, not an AI diagnostic tool, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a dental product, not an algorithm.
7. The type of ground truth used: Not applicable, no study described.
8. The sample size for the training set: Not applicable, no study described.
9. How the ground truth for the training set was established: Not applicable, no study described.
Additional Information from the 510(k) Summary:
While not directly about acceptance criteria or a performance study, the document does provide information relevant to the device's regulatory pathway:
- Substantial Equivalence: The primary conclusion is that "The information discussed above demonstrates that the Remesense device is substantially equivalent to the predicate devices." This is the basis for its clearance, not necessarily a direct demonstration of meeting pre-defined acceptance criteria through a new study.
- Predicate Devices: The submission relies on comparison to predicate devices, including UltraEZ (K061438), Orajel (K041680), SuperSeal (K983477), and Provident (K073061). The comparison table highlights similarities in indications for use (tooth desensitizer), mode of action (tubule occlusion), and often material composition (Potassium Oxalate for Remesense and Superseal).
- Technological Characteristics: The summary describes the mechanism of action: "Potassium oxalate breaks down into potassium and oxalic acid. The oxalic acid reacts with calcium ions to form calcium-oxalate crystals. These crystals block the dentin tubules, thereby alleviating dental sensitivity." This is presented as a "commonly used" method.
In summary, for this particular 510(k) submission, the "study" proving the device's suitability is the comparison to already-marketed predicate devices, demonstrating substantial equivalence in technology, intended use, and safety/effectiveness, rather than a de novo clinical trial with specific performance acceptance criteria.
§ 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.