Search Results

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

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.

Ask a specific question about this device

SmartCoat 2.5% NaF Varnish is intended for use on sensitive teeth, over exposed dentin . and root surface sensitivity, and under temporary restorations or cements where post operative sensitivity is of concern.
. Rapid Desensitizer
. Provides rapid relief from sensitive teeth due hypersensitivity

SmartCoat 2.5% NaF Varnish is classified as a Cavity Varnish (21 CFR 872.3260) because it is a device that provides relief from tooth surface hypersensitivity when applied to dentin surfaces by forming a film that facilitates occlusion of compromised surfaces including open dentinal tubules.

SmartCoat is a topically applied, flavored cavity varnish containing sodium fluoride in a shellac resin based preparation. The varnish is an insoluble viscous liquid that dries once applied to the teeth to form a surface film. The packaging provides an accurate dosing and uniform dispensing mechanism for consistent product mixing and delivery.

The provided document describes the acceptance criteria and a study to demonstrate the performance of the SmartCoat™ 2.5% NaF Varnish.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: "Human dentin slabs" were prepared and used. The exact number of slabs (sample size) is not specified in the document.
• Data Provenance: The study was a bench performance test conducted in a lab setting, not involving human subjects. The provenance of the human dentin slabs (e.g., country of origin) is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• The document states that the testing involved "subjective light microscopy analysis." It does not specify the number of experts or their qualifications for establishing the ground truth (i.e., rating the occlusion).

4. Adjudication Method for the Test Set:

• The document implies a subjective analysis but does not specify any formal adjudication method (like 2+1, 3+1, or none) for the assessment of dentin tubule occlusion. Ratings were assigned, but the process of how these ratings were finalized is not detailed.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. The described study is a bench performance test focused on the physical occlusion property of the varnish, not on human reader performance, with or without AI assistance.

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

• Not applicable. This device is a dental varnish, not an algorithm or AI system. The performance study evaluates the physical properties of the varnish itself.

7. The Type of Ground Truth Used:

• The ground truth for this bench test was established by subjective light microscopy analysis at 500x magnification to observe dentin tubule occlusion. This involved visual assessment and ranking on a defined scale.

8. The Sample Size for the Training Set:

• Not applicable. This device is a dental varnish, not a machine learning model. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for a machine learning model, this question does not apply.

Ask a specific question about this device

• Treatment of hypersensitive teeth
• Use on exposed dentin and root sensitivity
• Under temporary restoratives and cements where post-operative sensitivity is of concern.

PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces. The properties, intended use and composition are equivalent to the predicated devices and other current varnishes which are rosin based insoluble mixtures that form a film when applied to tooth surfaces. PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used in predicate devices which include but are not limited to Duraflor, Duraphat and Fluorilaq. The product comes in a single unit dose package containing the varnish and separate applicator brush.

The provided 510(k) summary for the PCXX Fluoride Varnish does not contain the information requested in points 1-9 regarding specific acceptance criteria and a study demonstrating the device meets those criteria.

This 510(k) submission is for a medical device that is a cavity varnish, specifically a 5% Sodium Fluoride Varnish. The basis for substantial equivalence is the technological characteristics and composition being identical to predicate devices. It relies on the assertion that "There are no performance standards established for this product in an ethanol solution. There are no performance specifications to assess how it to be substantially equivalent, performance will be the same."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study, as this information is not present in the provided text.

Here's a breakdown of what is stated, which indirectly addresses some points by explaining why the typical study information is absent in this type of submission:

1. A table of acceptance criteria and the reported device performance

• Not provided. The submission explicitly states: "There are no performance standards established for this product... There are no performance specifications to assess how it to be substantially equivalent, performance will be the same." This indicates that the regulatory body does not require specific numerical performance criteria or a comparative performance study for this type of device to demonstrate substantial equivalence, as long as its composition and intended use are identical to established predicates.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. No test set or performance study data is presented.

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 / Not provided. No ground truth establishment is described for a performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. No test set or adjudication process is 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

• Not applicable. This device is a topical varnish, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study would be relevant or conducted.

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

• Not applicable. This is a physical medical device (varnish), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. No ground truth for device performance is mentioned as the submission relies on equivalency of composition and manufacturing.

8. The sample size for the training set

• Not applicable / Not provided. No training set for an algorithm is relevant here.

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

• Not applicable / Not provided.

Summary of the 510(k) Claim:

The 510(k) submission for PCXX Varnish establishes substantial equivalence based on the following:

• Identical Composition: "PCxx Varnish used the same rosin (colophony) and rosin derivatives that are used... include but are not limited to Duraflor, Duraphat and Fluorilaq."
• Identical Intended Use: "PCxx Varnish is 5% Sodium Fluoride Varnish that reduces tooth sensitivity by forming a film when topically applied to enamel and dentin surfaces." This is presented as equivalent to predicate devices.
• No Established Performance Standards: The key argument for not needing a performance study is the absence of specific performance standards for this type of product. The assumption is that if the composition and intended use are the same, the performance will also be the same.

Ask a specific question about this device

Pulpdent Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film.

Copal Varnish with Fluoride is a resin-based varnish that is applied to enamel or dentin for professional treatment of dental hypersensitivity by occluding dentinal tubules with an adherent film.

The provided text is for a 510(k) premarket notification for a dental varnish. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics typically associated with AI/ML devices or devices requiring detailed performance studies.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details cannot be fully extracted or accurately inferred from the provided documents. The documents explicitly state that the device's safety and effectiveness are established by its substantial equivalence to predicate devices that "have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems."

Here's an attempt to address the points based on the available information, noting where the information is not present or not applicable in this context:

1. Table of acceptance criteria and the reported device performance

No explicit acceptance criteria or quantitative performance metrics (like sensitivity, specificity, AUC) are provided in the document. The substantial equivalence is based on design, composition, performance (in a general sense, meaning it functions similarly), and intended use being comparable to predicate devices. The "performance" is implicitly accepted as established by the long-term safe and effective use of the predicate devices.

2. Sample sized used for the test set and the data provenance

No specific test set or clinical study with a defined sample size is described. The demonstration of safety and effectiveness relies on substantial equivalence to predicate devices.

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

Not applicable. No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set

Not applicable. No test set requiring adjudication is 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

Not applicable. This is a dental varnish, not an AI/ML diagnostic device, so MRMC studies are irrelevant to this submission.

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

Not applicable. This is a medical device (dental varnish), not an algorithm.

7. The type of ground truth used

Not applicable in the context of a performance study for this device. The "ground truth" for its safety and effectiveness is the established history and regulatory acceptance of its predicate devices.

8. The sample size for the training set

Not applicable. No training set is mentioned as this is not an AI/ML device.

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

Not applicable for the same reason as above.

Summary of the basis for acceptance from the document:

The acceptance of "Copal Varnish with Fluoride" is based on demonstrating substantial equivalence to already legally marketed and established predicate devices. The document explicitly states:

"Copal Varnish with Fluoride is substantially equivalent in design, composition, performance, intended use, safety and effectiveness to the predicate products list have been on the market and used successfully by dental professionals for more than 15 years with no serious safety or effectiveness problems."

Therefore, the "study" that proves the device meets "acceptance criteria" (which are implicitly the criteria for substantial equivalence to the predicates) is the comparison presented in the 510(k) summary, which highlights the similarities in:

• Design
• Composition
• Performance (general function for treating dental hypersensitivity)
• Intended Use

The FDA's decision to clear the device (K100503) indicates that they accepted this argument of substantial equivalence.

Ask a specific question about this device