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510(k) Data Aggregation
(72 days)
NUPRO MODEL 13016901
NUPRO® cavity varnish is indicated for the coating or occlusion of exposed dentin tubules under temporary restorations, and for the treatment of hypersensitive teeth.
The NUPRO® cavity varnish is an ethanol based, sodium fluoride containing cavity varnish. The material is applied to tooth surfaces where hypersensitivity is a concern or to surfaces where dentinal tubule occlusion is indicated. The varnish is applied by a dentist to intact tooth surfaces, or to exposed dentin as a pre-treatment prior to application of temporary restorative materials. The material is a white opaque viscous liquid that is prepackaged in unitdose preloaded dispensing dishes with a disposable brush applicator.
The provided document is a 510(k) summary for the NUPRO® cavity varnish, which is a medical device. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the way that an AI/software device would.
Therefore, many of the requested categories for information (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set sample size) are not applicable to the type of device and submission described in the summary.
However, I can extract the relevant "performance data" presented in the document, which serves as the evidence for substantial equivalence, and frame it in a table format as requested.
1. Table of Acceptance Criteria and Reported Device Performance
For a traditional medical device like a cavity varnish, "acceptance criteria" are typically related to meeting specific performance parameters that demonstrate it is as safe and effective as a legally marketed predicate device. The "reported device performance" are the results of the specific tests conducted to show this.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: Device constituents are biocompatible. | "Laboratory tests on constituents of the device that are unique to the current submission demonstrate that such constituents are biocompatible." |
| Fluoride Content: Contains fluoride ion at the labeled concentration and is equivalent to predicates. | "Laboratory testing demonstrates that the subject device contains fluoride ion at the labeled concentration of 5% or 22,600ppm and is at least equivalent to the predicate devices which share similar labeled fluoride content." |
| Adhesion to Tooth Surface: Provides adhesion at least equal to predicate devices. | "Laboratory testing demonstrates that the subject device provides adhesion to the tooth surface at least equal to that of the predicate devices with an average lateral shear adhesion force of 77kPa." |
| Penetration of Dentin Tubules: Capable of penetrating exposed dentin tubules. | "Photomicrographs of the subject device reveal that it is capable of penetrating exposed dentin tubules to a minimum of 3-5 microns." |
| Prevention of Fluid Ingress: Substantially equivalent to predicates in preventing fluid ingress into dentin tubules. | "Laboratory dye penetration tests demonstrate that the subject device is substantially equivalent to the predicate devices in preventing the ingress of fluids into the exposed dentin tubules." |
| Conformity to Standards: Complies with relevant recognized standards. | "The NUPRO® cavity varnish was evaluated in terms of the recognized standard ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry." |
Study Proving Acceptance Criteria:
The study proving the device meets the (implied) acceptance criteria is a series of laboratory tests designed to demonstrate the material and performance characteristics of the NUPRO® cavity varnish are equivalent to its predicate devices (Ascent F-Coat and DuraShield). These tests are typically conducted in vitro or ex vivo to assess specific physical, chemical, and biological properties.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For material science performance tests, "test set" and "data provenance" as applied to AI/software are generally not applicable in the same way. The tests would involve laboratory samples (e.g., extracted teeth, material specimens) rather than patient data.
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)
This information is not applicable as the ground truth for these types of material science and biocompatibility tests is established through objective laboratory measurements and standardized protocols, not expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as there were no human readers or subjective interpretations requiring adjudication for these laboratory tests.
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 information is not applicable. This device is a material (cavity varnish), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a physical product (cavity varnish), not an algorithm or software. Its performance is inherent to the material properties.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance characteristics reported (e.g., fluoride content, adhesion, tubule penetration, fluid ingress) was established through objective laboratory measurements using recognized scientific methods and standards. For example:
- Fluoride content: Chemical analysis.
- Adhesion: Mechanical testing (lateral shear adhesion force).
- Tubule penetration: Photomicrography/microscopic examination.
- Fluid ingress: Dye penetration tests.
- Biocompatibility: Evaluation against ISO 7405:2008 standards.
8. The sample size for the training set
This information is not applicable. This device is a physical product, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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