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Zenoflex dimension is a dental ceramic, which is suitable for veneering hard-sintered zirconium dioxide frameworks with a coefficient of thermal expansion (CTE 25-500°C) of approx. 10.5 x 10° K 1.

Zenoflex dimension is a dental porcelain system that consists of about 150 different ceramic powders and it is intended to be used by professional dental technicians to manufacture all-ceramic dental appliances for the sole use of particular patients. Zenoflex dimension is recommended for veneering zirconium dioxide (ZrQs) frameworks with a coefficient of thermal expansion [CTE ¿25-500°C]] of approximately 10,5 x 10° Ki¹.

The Zenoflex dimension ceramic offers the dental technician the possibility to chose between different kinds of laver techniques considering aesthetical and economical aspects.

The "One layer technique", which is a fast and simple procedure to manufacture ceramic restorations, considers primarily the economical aspects. For manufacturing ceramic restorations the user needed numerous types of ceramic (dentine and incisal ceramics) so far. But now less types of ceramic are necessary for manufacturing anatomical crowns or bridges and for achieving the desired dental colour.

The "Three layer techniques" enable the user to achieve a dental restoration with a more aesthetical result, because this layer technique comprises the application of at least three different types of ceramic.

With the "Professional layer technique" the dental technician can carry out an extended professional build-up to achieve a dental restoration with the most aesthetical result.

Furthermore the Zenoflex dimension ceramic enables the user to manufacture dental restorations with colours of the "VITA Toothguide Classical" as well as of the "VITA Toothguide 3D-Master".

This is a 510(k) summary for a dental ceramic device (Zenoflex dimension). The provided document does not contain the sort of detailed study information (acceptance criteria, specific performance metrics, sample sizes, ground truth establishment, expert qualifications, etc.) that would be found in a study report for device performance evaluation as typically done for AI/ML-enabled medical devices.

The document outlines the device description, intended use, and comparison to a predicate device (Zirox) to establish substantial equivalence. The comparison focuses on physical, biological, and chemical properties tested according to international standards (e.g., ISO 6872, ISO 7405).

Therefore, it's not possible to populate the requested table and answer the study-related questions beyond what is explicitly stated for material properties.

Here's an attempt to answer based on the provided text, highlighting what is not available:

1. Table of acceptance criteria and the reported device performance

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

• Not specified. The document mentions testing "according to international accepted standards" but does not detail the specific test sample sizes or data provenance for these material property tests.

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 dental ceramic, and the ground truth for its performance is based on physical, chemical, and biological testing against established international standards, not interpretations by human experts in the context of diagnostic performance.

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

• Not applicable. See point 3.

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. This is not an AI/ML-enabled device, and no MRMC study was conducted.

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

• Not applicable. This is not an AI/ML device.

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

• The ground truth for the device's properties is established by international standards such as ISO 6872 (for physical and chemical properties of dental ceramics) and ISO 7405 (for biocompatibility of medical devices). The device's performance is measured against the specifications outlined in these standards.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML algorithm that requires a training set. The performance data relates to material properties derived from experimental testing against standards.

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

• Not applicable. See point 8.

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