Search Results

For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.

The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.

This document focuses on the substantial equivalence of the Sci-Pharm DFV Varnish to legally marketed predicate devices, rather than establishing acceptance criteria or performance through a clinical study with numerical metrics like sensitivity, specificity, or accuracy.

The manufacturer, Scientific Pharmaceuticals, Inc., sought 510(k) clearance from the FDA for their Sci-Pharm DFV Varnish. The clearance relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific, pre-defined acceptance criteria through a clinical performance study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is not directly applicable here because the submission is based on substantial equivalence, not a performance study against specific acceptance criteria. Instead, the document compares the chemical composition and device function to predicate devices.

2. Sample Sizes and Data Provenance

This information is not applicable as there was no formal "test set" in the context of a clinical performance study. The data provenance relates to the analysis of the chemical composition and physical properties of the Sci-Pharm DFV Varnish and its predicate devices.

• Sample Size for Test Set: Not applicable (no clinical test set for performance metrics).
• Data Provenance: The data regarding chemical composition and physical properties were likely generated in-house by Scientific Pharmaceuticals, Inc., through laboratory tests (IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, dry residue determination). The document doesn't specify if these were retrospective or prospective analyses, but they would have been performed specifically for the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

This is not applicable. Ground truth, in the sense of expert consensus on clinical diagnoses or outcomes, was not required for this type of submission. The "ground truth" here is the established chemical composition and functional behavior of the predicate devices and the Sci-Pharm DFV Varnish, determined through analytical laboratory techniques.

4. Adjudication Method

This is not applicable. There was no adjudication method used as this was not a clinical study involving human assessment of outcomes.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study assesses the impact of a device (often AI) on human reader performance, which is not relevant to a 510(k) submission for substantial equivalence of a dental varnish.

6. Standalone (Algorithm Only) Performance Study

No, a standalone study was not done. This submission is for a physical dental varnish, not an algorithm or software. The closest analogy would be the in-lab testing of the varnish's chemical and physical properties to demonstrate its equivalence.

7. Type of Ground Truth Used

The "ground truth" used for this submission was based on:

• Chemical Analysis: Laboratory results from techniques like IR spectrophotometry, pyrolysis, viscosity and refractive index measurements, and dry residue determination to confirm the identity and concentration of ingredients in both the new device and the predicate devices.
• Established Device Function: The document refers to the "accepted worldwide" uses of varnishes with similar compositions, indicating an reliance on existing clinical understanding and historical data for this class of devices.

8. Sample Size for the Training Set

This is not applicable as this is not an AI/machine learning device requiring a training set.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reason as above.

Ask a specific question about this device