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Primescan 2 can be used as a diagnostic aid by licensed dentists for detection of caries on visible tooth surfaces, proximal caries, and tooth cracks.

The Primescan 2 is an intraoral scanner that records and generates digital images to provide caries diagnosis support using additional light sources at 405 nm and 850 nm and an optical filter to filter out the excitation light. By illuminating the tooth with these two wavelengths, two diagnosis support modes are realized, the fluorescence mode and the near-infrared mode. The acquired 2D data from the scanner can be viewed in the software in a live stream video during acquisition. The images are also stored in the cloud platform software for later patient communication.

In fluorescence mode, the tooth (or teeth) are illuminated with UV light (405 nm). This stimulates an autofluorescence of the enamel in the green wavelength range. In addition, the red fluorescence is stimulated in carious areas on the teeth. All stimulated fluorescence responses are significantly weaker in terms of their light intensity compared to the back-reflected excitation light. For this reason, the excitation light is filtered out with the aid of an optical filter. The dental professional can use the 2D image data of the fluorescence response (live stream video) as additional information for caries diagnosis.

For near-infrared mode (NIR mode), the tooth or teeth are illuminated with 850 nm. Enamel is partially transparent in this wavelength. The illumination can therefore penetrate the tooth and is reflected by structural defects such as cracks and cavities, as well as from the dentin core. The reflected light is picked up by the 2D sensor of the scanner.

When used, a sleeve is placed over the distal end of the scanner. This sleeve is the only patient contacting component and is offered as either a single-use disposable or a multi-use sleeve that is reprocessed.

Here's the breakdown of the acceptance criteria and study information for the Primescan 2 device, based on the provided FDA 510(k) clearance letter:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific table outlining them. However, it does mention that "in vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This implies that the device met an unstated level of effectiveness for these diagnostic aids.

Since specific quantitative metrics (e.g., sensitivity, specificity, accuracy) are not provided in the summary, we cannot populate a detailed table with numerical acceptance criteria and performance outcomes.

Study Details

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided document.
• Data Provenance: The study was "in vivo bench tests," implying data was collected from living subjects. The country of origin and whether it was retrospective or prospective is not explicitly stated.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned in the provided document. The study described is "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid..." This describes standalone device performance rather than human-in-the-loop improvement.

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

• Standalone Performance Study: Yes, a standalone performance study was done. The document states: "Performance Validation Testing of the Caries diagnostic Aid - In vivo bench tests demonstrated that Primescan-2 is effective as a diagnostic aid for occlusal caries using the fluorescence function and tooth cracks using the NIR function." This indicates the device's ability to provide a diagnostic aid on its own.

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

• Type of Ground Truth: Not explicitly stated. For "in vivo bench tests" related to caries and tooth cracks, ground truth would typically be established through a combination of visual-tactile examination by experienced clinicians, potentially supplemented by radiography or even histology (though less common for a diagnostic aid). However, the document does not specify the method used here.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable or not specified. This device appears to be a direct imaging and diagnostic aid rather than an AI/ML algorithm that requires a separate training set. The "diagnostic support" refers to the illumination and optical filtering techniques, not necessarily an AI algorithm trained on a dataset.

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

• Ground Truth for Training Set: Not applicable, as there's no indication of an AI/ML algorithm with a training set. The device operates on optical principles.

Key Observations and Limitations of Information:

• The provided 510(k) summary focuses highly on technological comparisons, safety, and regulatory compliance (electrical safety, biocompatibility, reprocessing, software, cybersecurity).
• While it mentions "Performance Validation Testing," it lacks specific quantitative results (e.g., sensitivity, specificity, accuracy, AUC) that are typically associated with diagnostic device clearances.
• The clinical study details, such as sample size, expert qualifications, and ground truth establishment methods for the performance validation, are not provided in this specific document. This information would typically be in a more detailed study report submitted to the FDA, but is summarized very broadly here.
• The device is described as providing "diagnostic support" using optical modes (fluorescence and NIR), rather than an explicit AI algorithm.

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