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For use as a color-indicator of caries demineralized dentin. The water-soluble dye differentiates between dentin infected by caries and uninfected demineralized dentin and serves as a guide for the dentist-user in conservative caries removal during restoration.

CARIES STAIN may be described as a water-soluble solution of dye in solvent that selectively stains carious, infected dentin. It differentiates between non-remineralizable and remineralizable dentin to serve as a guide for conservative caries removal while maintaining as much vital tooth structure as possible.

The provided text is a 510(k) summary for a dental product called "CARIES STAIN," which is a caries indicator/detector. It describes the product's intended use and lists equivalent devices, but it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot fulfill most of your request as the necessary data is not present in the provided document.

Here's what can be extracted based on the information given, and an explanation of why other parts cannot be answered:

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

• Cannot be provided. The document describes the product and its intended use but does not present any performance data or acceptance criteria.

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

• Cannot be provided. This information is not present in the 510(k) summary.

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)

• Cannot be provided. This information is not present in the 510(k) summary.

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

• Cannot be provided. This information is not present in the 510(k) summary.

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

• Cannot be provided. The device is a "water-soluble solution of dye in solvent," not an AI-powered device. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.

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

• Cannot be provided. As noted above, this is a chemical staining solution, not an algorithm. Therefore, "standalone" algorithmic performance is not applicable or discussed.

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

• Cannot be provided. The document does not describe any studies with ground truth. The device itself is intended to help differentiate between carious and uninfected dentin to guide conservative caries removal. The "ground truth" in clinical practice would be the actual state of the dentin, likely confirmed by visual, tactile, and potentially histological examination during the procedure. However, the document does not detail how this was established for any regulatory study.

8. The sample size for the training set

• Cannot be provided. There is no mention of a training set as this is a chemical product, not a machine learning model.

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

• Cannot be provided. Not applicable (see point 8).

The 510(k) summary focuses on the product description, its intended use, and its substantial equivalence to other existing devices, which is the primary purpose of a 510(k) application. It does not typically include detailed clinical study protocols, performance data, or ground truth establishment methods in the way a more comprehensive clinical trial report would.

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