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5% Sodium Fluoride Varnish is indicated for sealing of dentinal tubules for the treatment of hypersensitive teeth, sensitive root surfaces and for cavity preparations.

5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.

The provided document describes the 510(k) summary for "5% Sodium Fluoride Varnish." This is a medical device application for a product that is not software-based or AI-driven. Therefore, many of the requested categories in the prompt, such as "sample sizes for the test set," "number of experts used to establish ground truth," "adjudication method," "MRMC study," "standalone performance," and "training set details," are not applicable.

The document focuses on demonstrating the substantial equivalence of the 5% Sodium Fluoride Varnish to a predicate device (Fluoride Varnish K031932) through non-clinical performance data and biocompatibility testing. No clinical performance data was considered necessary due to the low-risk nature of the device and commonality of materials.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and 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)

• Sample Size: Not specified. The document states "non-clinical performance data included testing for tubule occlusion, viscosity, retention on the tooth surface, fluoride release and fluoride content." For biocompatibility, it states "Biocompatibility testing was performed according to ISO 10993-1:2009." Specific sample sizes for these tests are not provided in the summary.
• Data Provenance: Not specified, but generally, tests supporting a 510(k) submission are conducted in a controlled lab environment. This is considered a "bench test" or in vitro 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)

• Not applicable. This device is a fluoride varnish, and its performance is evaluated through physical, chemical, and biological testing (biocompatibility), not through expert interpretation of data like medical images.

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

• Not applicable. There is no human interpretation or ground truth establishment requiring adjudication for this type of device testing.

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 not an AI-assisted diagnostic or interpretative device; it's a topical dental product.

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

• Not applicable. There is no algorithm or AI component to this device.

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

• The "ground truth" for this device's performance is established by the results of standardized in vitro bench tests that measure physical properties (viscosity, fluoride content/release, retention) and biological interaction (tubule occlusion efficacy, biocompatibility). These are objective measurements against established scientific standards.

8. The sample size for the training set

• Not applicable. There is no training set as this is not a machine learning or AI device.

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

• Not applicable. There is no training set.

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Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.

The modified varnish has the following similarities to that which previously received 510(k) concurrence:

• Has the same active ingredient at the same concentration; .
• has the same indications for use; .
• incorporate the same or similar materials; .
• has the same shelf life, and; ●
• is packaged using the same materials and processes.

I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is primarily a 510(k) summary and an FDA clearance letter for a dental varnish, outlining its substantial equivalence to a predicate device and its indications for use. It does not include the results of a clinical study or performance testing.

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Pulpdent VARNISH I, II, III, and IV are desensitizing cavity varnishes and dentinal tubule sealers. They are indicated for exposed sensitive dentin or cementum after scaling, prophylaxis, cavity preparation and prior to any cementation and pin or post seating. Pulpdent VARNISH forms a hard protective coating which protects dentin and pulp, reduces acid diffusion from cements, minimizes marginal leaks and acts as a thermal insulator. This coating controls dentinal fluid flow by sealing the dentinal tubules and producing a physiologic barrier. Pulpdent VARNISH is used by the dental professional to control thermal shock and sensitivity in teeth undergoing treatment or restoration. It can be applied to all prepared cavities, to dentin and enamel, with or without the smear layer removed. Pulpdent VARNISH can be used under veneers, inlays, crowns, onlays, amalgams and composite resins and to treat cervical or root sensitivity.

Pulpdent VARNISH I, II, III and IV are mixtures of either copal resin or polyamide resin and strontium chloride in organic solvent. The formulas for Varnish III and IV also contain the surfactant, cetyl pyridinium chloride.

This document is a 510(k) premarket notification for a dental device, "PULPDENT CAVITY VARNISH," submitted to the FDA in 1998. It does not include information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/software device submission would. Instead, it relies on the concept of "substantial equivalence" to predicate devices.

Therefore, for aspects of your request that pertain to modern AI/software device evaluation (like sample sizes for test/training sets, expert ground truthing, MRMC studies, or standalone performance), the document provides no relevant information.

Here's how the available information maps to your request:

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

This document describes safety and effectiveness in terms of historical use and substantial equivalence, not specific quantitative acceptance criteria or performance metrics derived from a study.

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

No test set or associated data provenance is described. The submission relies on "substantial equivalence" and historical literature.

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. No ground truth establishment for a test set is described.

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

Not applicable. No test set 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 non-AI dental varnish, and no MRMC study was conducted.

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

Not applicable. This is a non-AI dental varnish.

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

The closest concept to "ground truth" here is the historical scientific and clinical literature, which provides evidence for the safety and effectiveness of cavity varnishes of similar composition over time, and the implicitly accepted "ground truth" that the predicate devices are safe and effective for their intended uses. This is a regulatory "ground truth" by precedent rather than a specific study's ground truth.

8. The sample size for the training set:

Not applicable. There is no training set for an algorithm described.

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

Not applicable. There is no training set or associated ground truth establishment described.

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Cavity varnish is used for sealing cavities before restorations. It provides a barrier against the passage of irritants from cements or other restorative materials and reduces the penetration of oral fluids at the restoration-tooth interface into the underlying dentin. It also minimizes postoperative sensitivity when applied to dentinal surfaces under newly placed restorations.

Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)

Acceptance Criteria and Device Performance for Dentinal Tubuli Seal:

Based on the provided documents, it is not possible to extract specific quantitative acceptance criteria or detailed study results for the Dentinal Tubuli Seal. The documents are a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. This type of clearance typically relies on demonstrating equivalence in terms of indications for use, technological characteristics, and safety and effectiveness, rather than meeting specific pre-defined quantitative performance metrics in a new clinical study.

Therefore, the following sections will indicate "Not Applicable" or "Not Provided" where the requested information is not present in the given FDA letter.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not provided in the document. 510(k) clearance often relies on existing data from the predicate device and potentially product specifications rather than a new standalone clinical test set.
• Data Provenance: Not provided in the document.

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

• Number of Experts: Not provided in the document.
• Qualifications of Experts: Not provided in the document.

4. Adjudication method for the test set:

• Adjudication Method: Not provided in the document.

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:

• MRMC Study: Not applicable. This device is a cavity varnish, not an AI-assisted diagnostic tool.

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

• Standalone Performance: Not applicable. This device is a physical product (cavity varnish), not an algorithm.

7. The type of ground truth used:

• Type of Ground Truth: Not explicitly stated. For a 510(k) submission of a cavity varnish, ground truth would typically be established based on accepted dental practices, material science principles, and existing clinical data or performance data of the predicate device, rather than patient outcomes or pathology from a new study.

8. The sample size for the training set:

• Sample Size for Training Set: Not applicable. This device is a physical product, and the concept of a "training set" as understood in machine learning/AI does not apply.

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

• Ground Truth for Training Set: Not applicable. The concept of a "training set" does not apply to this device.

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