Search Results

Final cementing of all-ceramic, composite, or metal inlays, onlays, crowns and bridges; 2-3-unit Maryland bridges and 3-unit inlay/onlay bridges (excluded for patients with bruxism or periodontitis); Final cementing of posts and screws; Final cementation of all-ceramic, composite, or metal restorations on implant abutments.

Malta is a dual-curing, self-adhesive resin cement available in an automix syringe. It contains bi-functional (meth)acrylate. The proportion of inorganic fillers is about 70 % by weight; the grain size (D 90 %) is about 12.5 µm. The mixing ratio, based on volume, is 1 part base paste : 1 part catalyst paste. The two pastes are mixed by a static single use mixer attached to the syringe. Malta is available in various shades.

The provided text describes a dental cement product called "Malta" and its performance characteristics, comparing it to predicate devices to establish substantial equivalence for regulatory purposes. However, it does not contain information about a study involving an AI device or a comparative effectiveness study with human readers.

Therefore, I can only provide information related to the acceptance criteria and performance data for the dental cement "Malta," as well as details about the study that demonstrates this performance. Questions pertaining to AI, human readers, ground truth for AI, training sets for AI, or adjudication methods are not applicable based on the provided text.

Here's the information derived from the provided text regarding the dental cement Malta:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for each individual test or the specific data provenance (e.g., country of origin, retrospective/prospective) for these tests. It only states that "Biocompatibility testing was carried out." and presents performance data alongside predicate device data. These tests were likely conducted under controlled laboratory conditions to meet ISO standards.

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

This question is not applicable. The study is a laboratory-based performance evaluation of a dental material, not a clinical study requiring expert diagnosis or ground truth establishment in that typical sense. The "ground truth" here is the physical and mechanical properties of the material determined by standardized testing methods.

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

This question is not applicable. Adjudication methods typically apply to studies where human interpretation or classification is involved, such as medical imaging analysis. The presented data are objective measurements from laboratory tests.

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

This question is not applicable. The document describes a dental cement, not an AI device or a study involving human readers.

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

This question is not applicable. The document describes a dental cement, not an AI algorithm.

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

The "ground truth" in this context refers to the objectively measured physical and mechanical properties of the dental cement, established through standardized laboratory testing procedures defined by ISO (International Organization for Standardization) standards (e.g., ISO 4049:2000, ISO 9917:2001, ISO 2039-1:2000).

8. The sample size for the training set

This question is not applicable. There is no mention of a "training set" as this is not an AI or machine learning study.

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

This question is not applicable. There is no mention of a "training set" or "ground truth" in the context of an AI study. The performance data for Malta was established through direct measurement using recognized international standards.

Ask a specific question about this device