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ICE CERAMICS, ICE CERAMICS TISSUE, ICE CERAMICS DENTINE +, ICE CERAMICS DYNAMIC DENTINE, FRESCO ENAMEL, FRESCO GINGIVA, FRESCO, FRESCO DENTINE + and FRESCO DYNAMIC DENTINE are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.
ICE STAINS, ICE STAINS PRETTAU®, ICE STAINS GLAZE FLUO and ICE STAINS 3D are type I ceramics for coating, staining and glazing dental restorations made of final-sintered zirconia. They are conceived for patients who require dental restorations in zirconia, such as single crowns, bridges, inlays, onlays or veneers.

All devices included in this submission are dental glass ceramics. There are different device types from three device groups: ICE Ceramics Group, ICE Stains Group, and Fresco Group. The devices are supplied in form of powders or pastes and are available in different colors and/ or in different quantity sizes. Specific accessories are supplied for mixing or changing viscosity.

The provided text describes a 510(k) premarket notification for dental glass ceramics (ICE Ceramics, ICE Stains, Fresco) and includes non-clinical testing data to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance, nor does it present acceptance criteria in terms of diagnostic performance metrics like sensitivity, specificity, or AUC.

Therefore, many of the requested items cannot be answered from the provided document. The device in question is a dental material, not an AI-powered diagnostic tool.

Here's what can be extracted and what cannot:

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

The acceptance criteria are presented as performance requirements according to the relevant ISO standards for dental ceramics.

Additional Acceptance Criteria/Performance for Biocompatibility:
The device's biocompatibility was established according to ISO 10993-1 and ISO 10993-5, indicating it met the requirements of these standards. Specific numerical performance values are not provided, only that it was "established."

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

The document does not specify the sample sizes (e.g., number of restorations or test specimens) used for the non-clinical physical and chemical testing. It also does not mention data provenance as these are laboratory tests, not patient data studies.

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

Not applicable. Ground truth for dental material properties is established through adherence to standardized laboratory test methods (e.g., ISO 6872) and measurements, not expert consensus in the diagnostic sense.

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

Not applicable. Adjudication methods are relevant for diagnostic studies where human interpretation is involved.

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

No MRMC study was done. This document describes a dental material, not an AI-assisted diagnostic device.

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

Not applicable. This device is a dental material, not an algorithm.

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

For physical and chemical properties, the ground truth is established by standardized laboratory measurements as defined by ISO 6872 for flexural strength and chemical solubility, and ISO 10993 for biocompatibility.

8. The sample size for the training set

Not applicable. This device is a dental material, not a machine learning model.

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

Not applicable. This device is a dental material, not a machine learning model.

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