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For use as an aid in the detection and localization of subgingival dental calculus.

This submission is for a modification of a device system cleared under K983658, the DIAGNOdent®. The modification is in the form of a new accessory probe tip which can be connected to the unmodified DIAGNOdent® electronics system. The probe tip is longer and more slender to allow for the periodontal use. In-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements. The researchers identified the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface. Although the intensity of the detection was influenced by surrounding media, the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood.

The provide 510(k) summary does not contain sufficient information to describe the acceptance criteria and study that proves the device meets the acceptance criteria as requested. Specifically, the document mentions "in-vitro and preclinical studies" and "clinical studies" were conducted but does not provide details on the study design, sample sizes for test sets, data provenance, ground truth establishment, or specific performance metrics and their acceptance criteria.

Here's a breakdown of the information that is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in the provided text.
• Reported Device Performance: The document only states that "in-vitro and preclinical studies have shown that that laser fluorescence is correlated with materials in calculi and concrements" and that "the method of subgingival calculi detection to be a reproducible, objective method for assessing the root surface." It also notes that "the differences between cementum and calculus was highly significant in media like air, electrolytic solution and blood." No specific metrics (e.g., sensitivity, specificity, accuracy, precision) or numerical results are provided for the device for the subgingival calculus detection.

2. Sample size(s) used for the test set and the data provenance:

• Sample Size: Not provided.
• Data Provenance: Not provided. The studies cited are general scientific papers, not necessarily the specific studies conducted for this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not provided.

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

• Not provided.

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 mentioned. The device is for direct detection, not AI assistance for human readers.

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

• The device is a "Laser Fluorescence Caries Detection Device" (specifically, a periodontal probe accessory). It functions as a diagnostic tool that provides a reading, which a human then interprets. The summary doesn't describe an "algorithm only" performance study in the way AI would be evaluated. However, the in-vitro and preclinical studies would likely represent a standalone assessment of the device's ability to detect calculus. Specifics are lacking.

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

• Implied for the in-vitro studies that the "ground truth" would be the known presence of calculus in the samples tested. For preclinical studies, it would likely be confirmed by expert visual inspection or other established diagnostic methods. However, the specific method is not explicitly stated.

8. The sample size for the training set:

• Not applicable as this is not described as an AI/machine learning device requiring a training set. The device operates on direct physical principles (laser fluorescence).

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

• Not applicable.

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