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• 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.

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VOCO Profluorid Varnish is intended for use as

• Treatment of hypersensitive teeth,
• Sealing the dentinal tubules for cavity preparations or on sensitive root surfaces
• Cavity liner under amalgam restorations

VOCO Profluorid Varnish is a fluoride containing dental varnish for application to enamel surfaces as well as dentin for the treatment of hypersensitive teeth and for use as a cavity liner under amaigam restorations. VOCO Profluorid Varnish will for use as cavily a is tolerant to moisture and saliva.

This document is a 510(k) summary for the VOCO Profluorid Varnish, a dental product. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria in the way described in the request.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly present in the provided text. The document's purpose is to clear the device for market based on its similarity to existing, legally marketed devices and the established safety of its components.

Here's an analysis of the provided text in relation to your request:

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

This information is not explicitly stated in the document in the format of a typical performance study with specific acceptance criteria and reported results. The document relies on the "prior use of all of the components... in legally marketed devices" and "performance data and results provided" from those predicate devices to support its safety and effectiveness.

The document states:

• "The prior use of all of the components of VOCO Profluorid Varnish in legally marketed devices support our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary."
• "We believe that the prior use of the components of VOCO Profluorid Varnish in legally marketed devices and the performance data and results provided support the safety and effectiveness of VOCO Profluorid Varnish for the intended use."

This implies the acceptance criterion is essentially "demonstrates substantial equivalence to predicate devices which have established safety and effectiveness through their long-term market presence and prior data." The performance is implicitly accepted as being equivalent to these predicate devices.

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

Not applicable/Not provided for this submission. This submission does not detail a new clinical test set for performance. It relies on the established safety and performance of its components and predicate devices.

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

Not applicable/Not provided for this submission. There is no independent establishment of ground truth for a new test set described.

4. Adjudication method for the test set

Not applicable/Not provided for this submission. Since no new test set with human assessment is described, there's no adjudication method.

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 dental varnish, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance is irrelevant and not performed.

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

Not applicable. This is a physical dental product, not an algorithm.

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

The 'ground truth' for the safety and effectiveness of the components and the device's indications for use is based on the established regulatory clearance and market history of the predicate devices (Duraphat Fluoride Varnish K945794, K031932, and Duraflor Cavity Varnish K961893) and the FDA's clearance of ethyl cellulose as a food additive.

8. The sample size for the training set

Not applicable/Not provided for this submission. This is not an AI/machine learning device that requires a training set.

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

Not applicable/Not provided for this submission. See point 8.

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