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The DIFOTI System for Dental Examinations is indicated for detection of frank or incipient caries lessions above the gum line, and for monitoring the progression of such lesions.

The DIFOTI device is a dental examination system that utilizes visible light delivered with fiberoptic technology for transillumination imaging of teeth as a technique for visualizing dental caries. An electronic charge-coupled device (CCD) camera is used to capture the image(s), a small PC serves for for data acquisition and storage, and a computer monitor is used for image visualization,

The provided text is a 510(k) Premarket Notification for the DIFOTI Dental Examination System. It includes basic information about the device, its intended use, and a general statement about safety and performance testing. However, it does not contain specific details about acceptance criteria, detailed study results, sample sizes for test or training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot fulfill all parts of your request with the input provided.

Here's what can be extracted and what is missing:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not detailed in the document. The document only generically states "Safety and performance testing included image quality evaluation, software/hardware hazard analysis, invitro vs. in-vivo performance evaluation, and software verification and validation." It concludes that the device "has been shown to be safe and effective."

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective/prospective). While "in-vitro vs. in-vivo performance evaluation" is mentioned, no details are provided.

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)

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

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

• Adjudication Method: Not mentioned.

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 as being performed. The device is described as a "dental examination system" that utilizes visible light for transillumination imaging, and a CCD camera for image capture, data acquisition, and visualization. There's no indication of an AI component or a study comparing human readers with and without AI assistance.

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

• Standalone Performance: Not explicitly stated. The device functions as an imaging system for "detection" and "monitoring." While it captures images, it doesn't describe an automated diagnostic algorithm without human involvement.

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

• Type of Ground Truth: Not mentioned.

8. The sample size for the training set

• Sample Size: Not mentioned. The device predates the common use of "training sets" in the context of AI/machine learning. This filing is from 1999.

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

• Ground Truth Establishment: Not mentioned. (See point 8).

In summary, the provided 510(k) summary is very high-level and lacks the granular detail required to answer most of your questions regarding acceptance criteria and study particulars for device performance. It emphasizes the device's technical characteristics and comparison to predicate devices rather than detailed performance metrics from a specific study.

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