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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)

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.

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