(129 days)
Treatment of dentinal hypersensitivity. For use in adults over the age of 21.
FAgamin® is a professional treatment for dentin hypersensitivity. It is indicated for adults over 21 years of age.
FAgamin® is presented in a 5 ml black dropper bottle and contains a 38% w/v solution of diamine silver fluoride. Its design includes a secure screw cap and labeled container.
The provided document is a 510(k) Summary for the medical device FAgamin®, a cavity varnish for the treatment of dentinal hypersensitivity. It does not describe a study involving an AI/ML algorithm or its performance. The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than a clinical study proving device effectiveness against acceptance criteria in the context of AI.
Therefore, most of the requested information regarding acceptance criteria, study design for AI/ML, human expert involvement, and AI performance metrics cannot be found in this document.
However, I can extract information about the non-clinical tests performed and their criteria, which act as "acceptance criteria" for demonstrating substantial equivalence based on non-clinical performance.
Here's the information that can be extracted from the provided document:
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Parameters)
| Test/Assay | Parameter | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Appearance | Appearance | Clear Liquid | Clear Liquid |
| Color | Color | colorless | colorless |
| Odor | Odor | ammonia | ammonia |
| pH | pH | 8 a 10 | 8 to 10 |
| Density | Density (15°C) | 1.25 a 1.35 g/ml | 1.25 a 1.35 g/ml |
| Volhard titration | Silver Ions Conc. | 24.1- 26.8 % W/V | 24.1- 26.8 % W/V |
| SDF titration | Silver Diamine Fluoride Conc. | 36- 40% W/V | 36- 40% W/V |
| Potenciom. Selective ion elect. | Fluoride ion conc. | 4.2 - 4.7 W/V | 4.2 - 4.7 W/V |
| Microbiological Test | not applicable | not applicable | not applicable |
| Stability Test | Exp. Data | FAgamin® is physically and chemically stable in the proposed package for a period of 24 months | Pass (product remains stable during the proposed 2-year shelf life) |
| Dentin Hydraulic Conductance | Hydraulic Conductance | There were no significant differences between FAgamin® and Advantage Arrest p > 0.05. | Pass (% Average FAgamin ± DS 34.51 ± 12.61 vs. Predicate 30.72 ± 12.49; no significant differences) |
| Fluoride Release | Fluoride release rate | There are no significant differences between the two SDF [Subject Device and Predicate] in terms of fluorine ion release after application over teeth. | Pass (Maximum rate of fluoride release is 0.026 ppm/mm² for FAgamin®, vs. 0.024 ppm/mm² for predicate; no significant difference) |
| SEM- EDS | Tubule Obliteration | FAgamin® is similar to Advantage Arrest and both SDFs are desensitizing agents by obliterating the dentinal tubules with deposits containing silver, phosphorus and calcium. | Pass (Deposits of silver, calcium, fluoride, and phosphate were observed on dentin and blocking tubules, similar to predicate) |
| ISTA 3A | Package Protection | No external damage to the transport packaging was observed. | Pass (No external damage to the transport packaging was observed) |
| ISO 10993-5 Citotoxicity | Cytotoxicity | Non-Cytotoxic from a dilution of 1/320,000. | Pass (Non-Cytotoxic from a dilution of 1/320,000) |
| Sensitization | Sensitization Potential | It could not be demonstrated that the substance produces sensitization reactions. | Pass (It could not be demonstrated that the substance produces sensitization reactions) |
| Irritation | Irritation Potential | Under the conditions of the study, not an irritant | Pass (Under the conditions of the study, not an irritant) |
| ISO 10993-11 Sistemic Toxicity | Systemic Toxicity | The sample complies with the requirements of the assay | Pass (The sample complies with the requirements of the assay) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- The document does not specify a "test set" in the context of an AI/ML study.
- For the non-clinical tests, specific sample sizes (e.g., number of dentin samples, number of packages) are not provided in this summary.
- Data provenance (country of origin, retrospective/prospective) for these non-clinical tests is not detailed, though the applicant is from Argentina.
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. This document does not describe an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The non-clinical tests are laboratory-based.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This document does not describe an AI/ML study.
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 document describes a medical device (cavity varnish), not an AI/ML software. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This document describes a medical device, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" refers to the established scientific and engineering criteria and measurements (e.g., chemical composition analysis, physical properties, biological assays, comparison to predicate device).
8. The sample size for the training set
- Not applicable. This document describes a medical device, not an AI/ML algorithm. No training set was used.
9. How the ground truth for the training set was established
- Not applicable. This document describes a medical device, not an AI/ML algorithm. No training set was used.
Summary of the Study Performed (Non-Clinical for Substantial Equivalence):
The studies conducted for the FAgamin® device were non-clinical laboratory tests designed to demonstrate its substantial equivalence to a legally marketed predicate device (Silver Dental Arrest, K102973). The purpose was to show that FAgamin® is as safe and effective, and performs as well as or better than the predicate device.
The non-clinical tests covered:
- Physical and Chemical Properties: Appearance, color, odor, pH, density, silver ion concentration, silver diamine fluoride concentration, and fluoride ion concentration. These were compared against internal specifications and the predicate device's known properties.
- Stability: To ensure a 2-year shelf life.
- Efficacy surrogates:
- Dentin Hydraulic Conductance: Measured to demonstrate the device's ability to desensitize by reducing dentin permeability, with a criterion of no significant difference from the predicate device.
- Fluoride Release: Compared to the predicate device to ensure similar fluoride ion release, expected to contribute to its mechanism of action. The criterion was no significant difference.
- SEM-EDS Analysis: Used to observe the formation of deposits and obliteration of dentinal tubules, confirming a similar mechanism of action to the predicate. The criterion was similarity in effect and deposits.
- Biocompatibility: Tests according to ISO 10993 standards including cytotoxicity, sensitization, irritation, and systemic toxicity. Criteria were established based on standard biological safety assessments.
- Packaging Integrity: ISTA 3A test to ensure the packaging protects the contents during transport.
Conclusion from Non-Clinical Testing:
The document concludes that "The conclusions drawn from the non-clinical testing demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K102973."
No clinical testing was performed in support of this submission. Therefore, all performance claims are based on these non-clinical comparative tests.
§ 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.