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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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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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