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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.

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