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DenShield™ is intended for the rapid and continual relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules, which has been showmin the literature to be associated with a reduction in hypersensitivity.

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This is a 510(k) premarket notification for a dental device, DenShield™ Treatment for Sensitive Teeth, which is a cavity varnish. The document primarily focuses on regulatory approval and equivalence to predicate devices, rather than detailed performance studies or AI incorporation.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and AI performance is not available within the provided text.

Here's why and what information can be extracted:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states "Studies have shown that Dentibitly is effective at occluding exposed dentinal tubules..." but does not provide specific performance metrics or acceptance criteria.
• Sample sized used for the test set and the data provenance: No details on study sample size or origin are provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• 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 device is a cavity varnish, not an AI-powered diagnostic tool. This type of study is irrelevant.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: While "occluding exposed dentinal tubules" is mentioned as a mechanism for effectiveness, the specific ground truth for the "studies" is not described.
• The sample size for the training set: Not applicable for this type of device.
• How the ground truth for the training set was established: Not applicable for this type of device.

Information that can be extracted or inferred:

• Device Name: DenShield™ Treatment for Sensitive Teeth
• Device Type: Cavity Varnish
• Intended Use: Rapid and continual relief of hypersensitivity associated with exposed tooth dentin.
• Mechanism of Action (as stated): Effective at occluding exposed dentinal tubules.
• Regulatory Classification: Class II, Product Code: LBH, Regulation Number: 21 CFR 872.3260 (Cavity Varnish)
• Regulatory Decision: Substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
• Regulatory Body: Food and Drug Administration (FDA)
• Date of Approval: October 18, 2006 (OC) 1 8 2006)

This document is a regulatory approval letter, generally not the place where detailed scientific study results are presented. Those would typically be found in the 510(k) submission itself or in published scientific literature.

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