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510(k) Data Aggregation
(126 days)
Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in:
· Treating hypersensitive teeth
· Treating exposed dentin and root sensitivity
Clinpro™ Varnish is a fluoride, calcium and phosphate containing coating for use in treating hypersensitive teeth and exposed dentin and root sensitivity. Clinpro™ Varnish is moisture and saliva-activated when applied to enamel and dentin. It will spread on and adhere to moist teeth. Clinpro™ Varnish is an alcohol/water-based solution of dental polymer resins. The product is sweetened with xylitol and sucralose. Clinpro™ Varnish contains two fluoride sources, 3% sodium fluoride and 3% strontium fluoride (equivalent to 2.26% fluoride ion). Clinpro™ Varnish provides both an initial release in the first hour and a continued release during the next 24 hours. Clinpro™ Varnish also contains sources of calcium and phosphate, including functionalized tri-calcium phosphate exclusively from 3M ESPE. Clinpro™ Varnish is supplied in unit-dose packages containing 0.50 ml of varnish coating. Each 0.50 ml of Clinpro™ Varnish contains 13.8 mg sodium fluoride and 13.8 mg strontium fluoride, equivalent to 10.4 mg total fluoride ion.
The provided document describes the acceptance criteria and study for the Clinpro™ Varnish, a dental device. However, it's crucial to understand that this document is a 510(k) summary for a medical device and not a report for an AI/ML-based device. Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not provided in this context.
The acceptance criteria here refer to the device's compliance with established safety and performance standards for its intended use, typically demonstrated through non-clinical (in vitro, biocompatibility) testing, and comparison to legally marketed predicate devices.
Here's the breakdown of the information as much as it can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria (from predicate comparison & standards) | Reported Device Performance (Clinpro™ Varnish) |
|---|---|---|
| Intended Use | For treating hypersensitive teeth and exposed dentin and root sensitivity (similar to predicates). | Met: Intended use is consistent with predicate devices. |
| Indications for Use | For treating hypersensitive teeth and exposed dentin and root sensitivity (similar to predicates). | Met: Indications for Use are identical to the primary predicate device (Vanish™ 5% Sodium Fluoride White Varnish). |
| Basic Composition | Film-forming material (rosin varnish for predicates). | Met (with technological difference): Polymer Resin Varnish (film-forming material), which is stated to be "substantially equivalent in performance" to rosin varnishes. Contains fluoride (sodium and strontium), calcium, and phosphate. |
| Fundamental Technology | Dentin tubule occlusion. | Met: Achieves dentin tubule occlusion by forming a hardened resin film after application. |
| Performance (Dentin Tubule Penetration) | Ability to penetrate and occlude dentin tubules. | Met: SEM and optical images show the device forms a "thin film penetrating dentin tubules." |
| Performance (Fluoride, Calcium, Phosphate Release) | Release of active ingredients. | Met: "in vitro fluoride release testing shows that Clinpro™ Varnish provides both an initial release in the first hour and a continued release during the next 24 hours." Contains sources of calcium and phosphate. |
| Physical Properties (Shelf life) | Stable for a specified duration at room temperature. | Met: Stability testing confirms a shelf life of 24 months at room temperature. |
| Biocompatibility | No cytotoxicity, sensitization, irritation/intracutaneous reactivity, or acute systemic toxicity. | Met: Passed biocompatibility testing including cytotoxicity, sensitization, irritation/intracutaneous reactivity, and acute systemic toxicity, conforming to relevant ISO standards. |
| Manufacturing & Risk Management | Compliance with relevant ISO standards for medical devices. | Met: Complies with ISO 14971, ISO 10993-1, -3, -5, -10, -11, -12, and ISO 7405. |
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 document as it pertains to in vitro and biocompatibility testing, not human clinical trials with 'test sets' in the AI/ML sense. The in vitro tests likely involved dental models or extracted teeth. Biocompatibility tests would involve laboratory animals or in vitro cell cultures. The country of origin of the data is not specified, but the submission is from 3M Company in St. Paul, Minnesota, USA. The studies mentioned are non-clinical and would be prospective in their execution for the purpose of the 510(k) submission.
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/provided. "Ground truth" in the context of this device refers to the physical and chemical properties and biological responses observed in the in vitro and biocompatibility tests, not interpretations by human experts for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods are relevant for human interpretation tasks, not for the objective measurements of device performance in laboratory settings as described.
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/provided. MRMC studies are for evaluating the performance of AI-assisted human interpretation in diagnostic tasks. This device is a dental varnish, not an AI/ML diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. This device is a physical product (dental varnish), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established through:
- In vitro measurements: Objective laboratory measurements of dentin tubule penetration (evaluated via SEM and optical images) and fluoride, calcium, and phosphate release.
- Biocompatibility testing: Standardized biological assessments demonstrating the device does not cause adverse biological reactions (e.g., cytotoxicity, irritation).
- Comparison to predicate devices: The "ground truth" for substantial equivalence is that the device performs equivalently to existing, legally marketed similar devices that have established safety and effectiveness.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of this traditional medical device submission.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set, there is no ground truth established for one.
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