Search Results

1. Treats hypersensitive teeth
2. Treats exposed dentin and root sensitivity

FluoroCal is a fluoride & calcium releasing varnish with Tri-Calcium Phosphates (TCP) for application to enamel and dentin for the treatment of hypersensitive teeth. FluoroCal delivers targeted and sustained release of fluoride & calcium over 24 hours. This varnish penetrates and seals dentin tubules, providing immediate relief of sensitivity. Available in Spearmint; sweetened with Xylitol.

The provided document is a 510(k) summary for a dental product called "FluoroCal," a 5% Sodium Fluoride Varnish with Tri-Calcium Phosphate. This document primarily focuses on establishing substantial equivalence to predicate devices and does not describe a study to prove acceptance criteria in the typical sense of a clinical trial for a novel medical device.

FluoroCal is a dental varnish, not an AI/ML device, and therefore the acceptance criteria and study description provided in the document are for the physical/chemical properties and biocompatibility of the varnish, not for an algorithm's performance.

Based on the provided information, I can extract the following relevant details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes "Performance Data" and "Technological Characteristics" that serve as the indirect acceptance criteria by demonstrating equivalence to predicate devices.

2. Sample Size used for the test set and the data provenance:

The document does not specify a "test set" in the context of an algorithm's performance evaluation. The performance data is based on laboratory testing of the FluoroCal varnish itself. Therefore, sample sizes for these material property tests, and their provenance, are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as this is not an AI/ML device and no "ground truth" for a test set was established by experts in this context. The determination of "meets requirements" or "equivalent" is based on established ISO/ANS/ADA standards and laboratory measurements.

4. Adjudication method for the test set:

Not applicable. There was no "test set" requiring adjudication in the context of expert review for an algorithm.

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, as this is not an AI/ML device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable, as this is not an AI/ML device.

7. The type of ground truth used:

The "ground truth" in this context refers to established material property standards and scientific measurements:

• ISO 17730:2014(E) for Fluoride Content
• ANS/ADA Spec #8 4.3.2 for Consistency
• Laboratory measurements for pH, Calcium Release, Fluoride Release, and SEM for Tubule Occlusion.
• ISO 7405:2008 and ISO 10993-1 for Biocompatibility.

8. The sample size for the training set:

Not applicable, as this is not an AI/ML device and no "training set" was used.

9. How the ground truth for the training set was established:

Not applicable, as this is not an AI/ML device and no "training set" was used.

In summary: The provided document is a regulatory submission demonstrating the substantial equivalence of a dental varnish (FluoroCal) to existing predicate devices based on its chemical composition, physical/mechanical properties, and biocompatibility, as measured against established scientific standards. It does not describe an AI/ML-driven medical device or a study involving human readers or algorithm performance metrics.

Ask a specific question about this device