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The product is used either by a dental professional in the dental office or by a patient at home to treat dentin sensitivity.

Cosmedent TOOTH DESENSITIZER is a 3% potassium nitrate and 1200 ppm fluoride ion gel desensitizer. The indication for this product is tooth discomfort caused by dentine sensitivity. TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules. TOOTH DESENSITIZER is available as a clear, green-colored, gel. It can be used either by gently brushing the affected area with the product or it can be used in a custom tray.

The provided text is a 510(k) premarket notification for a tooth desensitizer. It details the device's description, intended use, and comparison to a legally marketed predicate device.

However, the document does not contain any information regarding clinical studies, performance data, acceptance criteria, sample sizes (for test or training sets), expert qualifications, adjudication methods, or MRMC comparative effectiveness studies.

The 510(k) summary (from document {0}) states: "TOOTH DESENSITIZER is a gel desensitizer device based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity due to patent dentinal tubules." This implies that the device's effectiveness relies on the known mechanisms of its active ingredients, rather than new clinical trials specifically for this product to prove novel efficacy beyond what is already established for these ingredients.

Therefore, I cannot populate the table or answer most of the questions you've posed, as the necessary information is not present in the provided text.

Here is what can be inferred or stated from the provided text:

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

• Acceptance Criteria: Not specified in the document.
• Reported Device Performance: Not specified as quantitative performance metrics. The document states it is "based on the well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," suggesting reliance on established scientific literature for its active ingredients rather than new performance data.

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

• Not specified. No test set data appears to have been presented.

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 specified. No ground truth establishment for a test set is mentioned.

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

• Not specified. No test set adjudication is mentioned.

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 medical device (tooth desensitizer), not an AI/imaging device.

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

• Not applicable. This is a medical device (tooth desensitizer), not an AI/imaging device.

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

• Not specified directly. The submission relies on "well documented effects of potassium nitrate and fluoride ion on dentine sensitivity," implying that the ground truth for their efficacy is based on existing scientific and clinical understanding of these active ingredients.

8. The sample size for the training set

• Not applicable. No training set is mentioned as this is not an AI/machine learning device.

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

• Not applicable. No training set is mentioned.

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