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Treating and preventing dentinal hypersensitivity. Can be used under direct restorations, under indirect restorations, and on cervical sensitivity.

The DENTIN DESENSITIZER AGENT is a chair-side agent for treating and preventing dentinal hypersensitivity.

The provided K073117 document is a 510(k) summary for a "DENTIN DESENSITIZER AGENT." This document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and biocompatibility.

It does not contain information about acceptance criteria or a study that rigorously proves the device meets specific performance criteria using a test set, ground truth, or expert review in the way that would typically be described for a diagnostic AI or imaging device.

Therefore, I cannot populate the requested table and detailed study information as the document does not provide this type of data.

Here's why and what information is present:

• Type of Device: The DENTIN DESENSITIZER AGENT is a chemical agent for treating tooth sensitivity, not a software algorithm, an AI device, or an imaging modality.
• Approval Pathway: This is a 510(k) submission, which means the device is being approved based on "substantial equivalence" to legally marketed predicate devices, not necessarily on demonstrating new performance metrics against a defined acceptance criterion via a clinical study with a control group and robust statistical analysis for novel claims.
• Focus of the Submission: The submission highlights:
  • Components: All components have been used in legally marketed devices or found safe for dental use.
  • Biocompatibility Testing: The device passed agar overlay cytotoxicity, intracutaneous irritation, and systemic toxicity tests. This demonstrates safety, but not clinical effectiveness in terms of reducing sensitivity in a quantifiable manner against specific criteria.
  • Predicate Devices: The device is compared to Gluma Desensitizer (K962812) and Quell Desensitizer (K010957). The implication is that since these predicates are accepted for treating dentinal hypersensitivity, and the new device shares similar characteristics and has passed safety tests, it is also safe and effective for the same indication.

Conclusion:

Based on the provided text, there is no information to fill in the requested table and answer questions 1-9 regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert qualifications, ground truth, adjudication methods, or MRMC studies. These details are typically found in submissions for devices that make novel performance claims or rely on AI/software for diagnostic or interpretive functions, which is not the case for this chemical desensitizer.

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