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The Vitique System is intended for use in permanent luting of definitive restorations of all kinds (metal, ceramic, composite), including veneers, crowns and bridges, onlays, telescopic crowns, attachments, pins and posts, orthodontic appliances, luting of ornaments, splinting etc. as well as a add-on for resin based materials. The Try-in pastes may also be used as a general water soluble separating agent (e.g. isolating material for use with prefabricated crowns, retraction cords etc.) or as an oxyguard gel.

The Vitique System consists of: Vitique Cement a highly aesthetic luting cement in various shades; Try-In Pastes that precisely match the corresponding cement shade to approximate the final result: Silanating agent for use in preparing ceramic surfaces for bonding; and Contax Bonding System a bonding system (etching gel, bonding system) for final bonding to tooth structure.

The provided documents are a 510(k) summary and FDA clearance letter for a dental luting material called the Vitique System. This type of submission is for a medical device (dental cement) and does not involve AI or algorithms that would have performance acceptance criteria in the way typically associated with AI/ML diagnostic devices.

Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and AI-specific performance metrics (like MRMC studies) is not applicable to this submission.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that the submission is an "Abbreviated 510(k)" and demonstrates conformity with "FDA's guidance document entitled Dental Cements - Premarket Notification, August 1998" and "ISO 4049 - Dentistry - Polymer-based filling, restorative and luting materials."

This means the acceptance criteria are based on the standards outlined in ISO 4049 and the general safety and effectiveness requirements for dental cements as per FDA guidance. The submission claims conformity, but specific quantitative acceptance criteria and detailed reported performance values are not provided in the summary. For example, ISO 4049 would specify requirements for properties like:

2. 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. Testing would typically involve a certain number of specimens for each physical and chemical property test required by ISO 4049.
• Data Provenance: Not specified. These would be lab-based tests performed according to specific standards, so "country of origin" from a clinical data perspective is not applicable. The studies would be prospective in the sense that they are specifically conducted to test the device's properties.

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):

• Not applicable. This device is a material, not a diagnostic algorithm. "Ground truth" in this context refers to standardized measurements of physical and chemical properties, not expert consensus on an image or clinical assessment. The "ground truth" is typically defined by the test methods themselves (e.g., a rheometer measures viscosity, a mechanical tester measures flexural strength).

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

• Not applicable. See point 3. Testing of material properties does not involve adjudication by experts.

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:

• Not applicable. This device is a dental cement, not an AI/ML diagnostic software. There are no "human readers" or "AI assistance" involved in its core function.

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

• Not applicable. This is not an algorithm.

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

• Material Property Standards/Measurements. The "ground truth" for a dental cement relies on established physical and chemical measurement techniques and the specifications outlined in relevant ISO standards (e.g., ISO 4049) and FDA guidance documents. For instance, the "ground truth" for flexural strength is the value measured by a calibrated universal testing machine.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning, so there is no training set.

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

• Not applicable. See point 8.

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