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The FluoreCam™ is intended to be used as an aid in the diagnosis of dental caries.
The FluoreCam™ is indicated as an aid in the diagnosis of dental caries.

The FluoreCam™ consists of a handheld instrument that interfaces with custom computer software via a USB connection. The instrument excites the surface of a tooth with light and transmits images of the surface to the software. The software quantifies carious activity using the auto fluorescent property of tooth enamel.

The provided text describes the FluoreCam™ device and its substantial equivalence to a predicate device, as well as the FDA's clearance. However, it does not include detailed information regarding specific acceptance criteria, prospective study design, sample sizes for test/training sets, expert qualifications, or adjudication methods for establishing ground truth for the device's performance study. The only performance information mentioned is a comparison testing using polarized light microscopy (PLM) as a gold standard.

Based on the provided text, here's what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

2. 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)

   • Number of Experts: Not specified. The ground truth was established using "polarized light microscopy as a gold standard," which typically refers to laboratory analysis by trained personnel, but their specific qualifications or number are not mentioned in this document.

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

   • Adjudication Method: Not specified. The document only states "comparison testing using polarized light microscopy as a gold standard."

4. 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

   • MRMC Study: No, an MRMC study is not described. The document states the device is "an aid in the diagnosis," but does not present a study on human reader improvement with or without the device.

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

   • Standalone Performance: The performance testing involved "comparison testing using polarized light microscopy as a gold standard." This implies evaluating the device's output against a gold standard, which can be considered a form of standalone performance evaluation for diagnostic accuracy. However, specific metrics (e.g., sensitivity, specificity, accuracy) are not provided.

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

   • Ground Truth Type: Polarized light microscopy. This is a common and highly regarded method for determining the extent of demineralization in dental hard tissues, making it a suitable "gold standard" for caries detection.

7. The sample size for the training set

   • Training Set Sample Size: Not specified. The document does not describe a training set or how the device's algorithm was developed.

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

   • Training Set Ground Truth: Not specified, as no training set is described in the provided text.

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