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3M™ Vitrebond 114 Light Cure Glass Ionomer Liner/Base is indicated for lining and basing applications under composite, amalgam, ceramic, and metal restorations.

3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base is comprised of a powder and a liquid component. The powder component is a light sensitive fluoro-aluminosilicate glass. The liquid component is a light sensitive polyalkenoic acid. The composition is a true glass ionomer exhibiting the major characteristics of glass ionomer products - it bonds to tooth structure, releases fluoride, and is a biocompatible material. Additionally, Vitrebond liner/base offers the unique combination of a prolonged working time with a very short set time achieved by exposure to light from a dental visible light curing unit. Polymerization by light exposure not only eliminates the set time waiting period common to auto set liners, it also provides enhanced mechanical and physical properties.

This document is a 510(k) summary for a dental product (3M™ Vitrebond™ Light Cure Glass Ionomer Liner/Base). It describes the product, its intended use, and its substantial equivalence to predicate devices.

However, the provided text does not describe a study that uses acceptance criteria for a device's performance in terms of algorithms, AI, or diagnostic accuracy. It is focused on regulatory clearance for a dental material, highlighting its chemical composition, existing global usage, and substantial equivalence to other dental products.

Therefore, the requested information elements related to AI/algorithm performance, ground truth, expert opinions, sample sizes for test/training sets, and MRMC studies cannot be extracted from this text. The acceptance criteria described are implicitly related to the safety and effectiveness of a dental material through its chemical composition and historical usage, rather than algorithmic performance metrics.

To answer your request, I will explain why each point cannot be addressed based on the provided text.

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

• Acceptance Criteria: Not explicitly stated in terms of performance metrics for an AI/algorithmic device. The acceptance criteria for this dental material are implicitly that it is safe and effective for its intended uses, as demonstrated by its chemical composition being virtually unchanged from a previously cleared device (Vitrabond, K882821) and its long-standing global usage with "excellent results."
• Reported Device Performance: The text states, "The fact that this material has been used globally for years with excellent results confirms the fact that this material is safe and effective for its intended uses." This is a general statement about the material's performance in a clinical setting, but it lacks specific quantitative performance metrics relevant to an AI or diagnostic device.

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

• Not applicable. The document does not describe a "test set" in the context of evaluating an algorithm or diagnostic device. The "data" refers to real-world usage of the dental material, not a formal study with a defined test set.

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. There is no mention of "experts" establishing a "ground truth" for a test set related to an AI or diagnostic device. The efficacy and safety are based on the material's chemical properties and historical clinical usage, not an expert panel reviewing cases.

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

• Not applicable. There is no test set or adjudication process described.

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 is a dental material, not an AI-assisted diagnostic device, so an MRMC study is not relevant here.

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

• Not applicable, as this is not an algorithm.

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

• For this dental material, the "ground truth" for its safety and effectiveness is established through its chemical composition, biocompatibility testing (toxicology and histology data from K882821), and real-world clinical outcomes over years of global use. It's not a ground truth for a diagnostic task.

8. The sample size for the training set

• Not applicable. There is no AI model or "training set" described.

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

• Not applicable.

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