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VITA AKZENT LC is a light-curing methacrylatebased stain/ glaze system for extraoral surface characterization of dental restorations made of hybrid ceramic, resin veneering materials, CAD/CAM composites, prefabricated teeth and denture base resins. It can also be used for internal characterization with the layering technique of veneering composites.

AI/ML Overview

The document describes the VITA Akzent® LC, a light-curing methacrylate-based stain/glaze system for extraoral surface characterization of dental restorations. The acceptance criteria and the study proving the device meets these criteria are outlined in the "Non-Clinical Performance Testing" and "Biocompatibility" sections.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Biocompatibility: Conformance to ISO 10993-1:2009 (Biological evaluation of medical devices) and ISO 7405:2004 (Dentistry – Evaluation of biocompatibility of medical devices).	A biocompatibility assessment was performed on VITA Akzent® AC in accordance with ISO 10993-1:2009 and ISO 7405:2008. The assessment supports that VITA Akzent® LC is biocompatible and concludes that the device is substantially equivalent to the predicate device in terms of biocompatibility.
Performance: General safety and effectiveness for its intended use as a coating material for resin fillings.	"Performance and biocompatibility testing prove that the subject device, in a liquid form, does not impact the safety and effectiveness of the product... The adhesion performance testing conducted against the reference device, shows a more favorable efficacy during bench testing."

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

The document does not specify a distinct "test set" in the traditional sense of a clinical study with human subjects. The evaluation was primarily based on non-clinical performance testing and biocompatibility assessment.

For biocompatibility, the testing was conducted in-vitro/non-clinical based on recognized international standards. Specific sample sizes for these tests (e.g., number of specimens tested for cytotoxicity, irritation, etc.) are not explicitly stated in this summary.
For adhesion performance, "bench testing" was conducted. The sample size for this testing is not explicitly stated.
The data provenance is not explicitly stated but is presumed to be from laboratory testing as per the cited ISO standards.

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

This information is not applicable and not provided in the document because the assessment was based on non-clinical (laboratory) testing and established international standards for biocompatibility and material performance, rather than clinical efficacy studies requiring expert evaluation of patient data.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided as the evaluation was based on objective laboratory testing against established standards, not human interpretation of results requiring adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of VITA Akzent® AC."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This concept is not applicable to this device. VITA Akzent® LC is a material (a stain/glaze system), not an algorithm or an AI-powered diagnostic tool. Its performance is determined by its physical and chemical properties as evaluated through non-clinical laboratory tests.

7. The Type of Ground Truth Used:

The ground truth for demonstrating the device's performance relies on:

Established international standards: ISO 10993-1 (Biological evaluation of medical devices) and ISO 7405 (Dentistry – Evaluation of biocompatibility of medical devices).
Bench test results: Specifically, "adhesion performance testing" against a reference device.
Material composition equivalence: Comparison of the chemical composition to predicate devices.

8. The Sample Size for the Training Set:

This information is not applicable and not provided. As VITA Akzent® LC is a material and not an AI/ML algorithm, there is no "training set" in the conventional sense. Its development would likely involve
iterative formulation and testing, but not machine learning training.

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

This information is not applicable and not provided, as there is no "training set" for this type of device. The formulation and development of the material are based on scientific principles of polymer chemistry and dental material science, combined with performance testing.

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