(1 days)
Treatment of dentinal hypersensitivity For use in adults over the age of 21.
e-SDF is a single component liquid device made up of 38% silver diamine fluoride.Silver diamine fluoride solution is applied to the tooth, to reduce tooth sensitivity by physically occluding the open dentinal tubules. e-SDF is a liquid that is applied to the teeth using an applicator brush or similar application.
The provided text describes a 510(k) summary for a medical device called "e-SDF." This device is a liquid made of 38% silver diamine fluoride, intended to treat dentinal hypersensitivity by occluding open dentinal tubules. The submission aims to demonstrate substantial equivalence to a predicate device, "Silver Dental Arrest (Advantage arrest)" (K102973).
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly list "acceptance criteria" in a quantitative sense with pass/fail thresholds. Instead, it presents a comparison of technological characteristics between the subject device (e-SDF) and the predicate device, aiming to show substantial equivalence. The performance is assessed through non-clinical testing.
| Acceptance Criteria (Implied by Equivalence Comparison) | Reported Device Performance (e-SDF) | Equivalence to Predicate (Silver Dental Arrest - K102973) |
|---|---|---|
| Intended Use | Treatment of dentinal hypersensitivity. For use in adults over the age of 21. | Similar |
| Classification Name | Cavity Varnish | Equivalent |
| Common Name | Tooth desensitizer | Equivalent |
| Classification Product Code & Regulation Number | PHR, 21 CFR 872.3260 | Similar |
| Material Composition | Silver diamine fluoride | Similar |
| Mode of Action | Tubule occlusion (forms precipitates with calcium or phosphate in the dentinal tubules to block open dentinal tubules) | Similar |
| Application | Liquid | Similar |
| Sterility, Packaging | Non-Sterile, Bulk Pack | Similar |
| OTC/Rx | Rx | Similar |
| Biocompatibility | Biocompatible as per ISO 10993-1 | Similar |
| Hydraulic Conductance (Functional Efficacy) | Effective agent to reduce fluid flow through dentine; substantially equivalent to Silver Dental Arrest (Advantage arrest) in treating dentinal hypersensitivity. | Substantially Equivalent |
| Mechanism of Action (Microscopic Evidence) | SEM images showed e-SDF formed a precipitate to occlude the open dentinal tubules. | Similar (predicate also forms precipitate) |
2. Sample Size for the Test Set and Data Provenance:
The document mentions a "Hydraulic Conductance study" and "Scanning electron microscope (SEM) images" as part of non-clinical performance testing. However, it does not specify the sample size used for these tests (e.g., number of teeth, dentin samples).
The data provenance is also not explicitly stated. It's non-clinical lab testing, so it likely occurred in a controlled laboratory environment, but the country of origin of the lab or whether it was prospective/retrospective is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the provided document describes non-clinical performance testing (a "Hydraulic Conductance study" and SEM imaging) rather than a clinical study requiring expert assessment for ground truth. The evaluation criteria for the Hydraulic Conductance study and SEM images would be based on scientific measurements and observations, not expert consensus on diagnoses.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reason as point 3. There is no human interpretation or diagnostic ground truth being established in the non-clinical tests 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:
This is not applicable. The device e-SDF is a dental product (cavity varnish/tooth desensitizer), not an AI-powered diagnostic imaging tool. Therefore, an MRMC study or AI assistance is not relevant to its performance evaluation as described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable. As mentioned above, the device is a dental product, not an algorithm, so the concept of standalone algorithm performance does not apply.
7. The type of ground truth used:
For the non-clinical tests described:
- Hydraulic Conductance Study: The ground truth would be the measured reduction in fluid flow through dentin, quantifiable by established scientific methods.
- Scanning Electron Microscope (SEM) Images: The ground truth is the visual evidence of precipitate formation and occlusion of dentinal tubules, observed microscopically.
8. The sample size for the training set:
This is not applicable. The e-SDF is a physical dental product, not a machine learning model, so there is no concept of a "training set" for its development or evaluation in the context of this submission.
9. How the ground truth for the training set was established:
This is not applicable for the same reason as point 8.
§ 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.