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D-Carie is indicated for aiding in the diagnosis of dental carries

Similar to the Diagnodent the D-CARIE is indicated for use in aiding in the diagnosis of dental caries. The D-CARIE probe is similar in intended use, size, and shape to a Diagnodent probe tip. Identical to the technology in the Detectar the D-CARIE probe contains an optical fiber that reads the optical signature of suspicious areas and converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination.

The provided 510(k) summary for the D-CARIE device offers limited details regarding specific acceptance criteria and the comprehensive study methodologies. However, based on the available information, here's an attempt to extract and describe the requested points:

The D-CARIE device is indicated for aiding in the diagnosis of dental caries.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not explicitly state the numerical sample size for any of the evaluations. It mentions "two in vitro and one in vivo evaluations" and "a third in vitro evaluation."
• Data Provenance: The studies were conducted in Canada, as the submitter, NEKS Technologies, is located in Laval, Quebec, Canada. The document states "Two in vitro and one in vivo evaluations... were conducted by experienced clinicians." It does not specify if these were retrospective or prospective studies, but "conducted by experienced clinicians" suggests a prospective setup for the clinical evaluations.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: The document states that the evaluations were "conducted by experienced clinicians." It does not specify the exact number of experts involved in establishing ground truth for the test set.
• Qualifications of Experts: The experts are described as "experienced clinicians." Specific qualifications like "radiologist with 10 years of experience" are not provided. Given the nature of dental caries detection, these
  "clinicians" would likely be dentists.

4. Adjudication Method for the Test Set

The document does not provide details on the adjudication method used for the test set (e.g., 2+1, 3+1, none). It only mentions "conducted by experienced clinicians."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not describe an MRMC comparative effectiveness study involving human readers with and without AI assistance. The comparisons mentioned are between D-CARIE and a predicate device (Diagnodent), not explicitly evaluating human reader improvement with D-CARIE.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)

The information provided focuses on the device's performance in comparison to predicate devices, and its intended use is "aiding in the diagnosis." It mentions that the device "converts it into an electrical signal. From that electrical signal a computer analysis identifies areas that need further examination." This implies a degree of standalone algorithmic processing. However, the studies described don't explicitly isolate and report standalone performance metrics in a way that separates the algorithm's output from subsequent clinical interpretation or diagnostic decision-making. The "equivalence to Diagnodent" suggests comparing the overall diagnostic aid.

7. Type of Ground Truth Used

The document does not explicitly state the specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). For dental caries studies, ground truth is often established through a combination of visual inspection, tactile examination (using dental explorers, which are themselves listed as predicate devices), and sometimes histological examination (pathology) for in vitro studies or follow-up over time for in vivo studies. Given the comparison to Diagnodent, which measures fluorescence, the ground truth likely involved a standard for identifying caries presence and severity.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. This suggests that the device either did not undergo a distinct machine learning "training" phase in the modern sense or that this information was not deemed necessary for the 510(k) summary given the predicates.

9. How the Ground Truth for the Training Set Was Established

Since no information is provided about a training set, there is no description of how ground truth for it was established.

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