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PressX Zr is a pressable dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by pressing-over zirconium dioxide frameworks. The indications of these all-ceramic restorations are defined by the manufacturers of the zirconium dioxide (ZrO2) framework material, and normally encompass dental crowns and bridges. The coefficient of thermal expansion [CTE (25 - 500°C]] of these zirconium dioxide (ZrO2) frameworks has to equal approximately 10 x 10°K1. In addition, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.

PressX Zr is a dental press ceramic system that is intended to be used by professional dental technicians to manufacture all-ceramic dental prostheses for the sole use of particular patients. The PressX Zr system consists of solid glass ceramic (porcelain) pellets, which are intended to be pressed onto zirconium dioxide frameworks at high temperature, and of porcelain powders, which are intended to stain these all-ceramic restorations, individually. After overpressing, the restoration can be finished either by using the staining- or by using the layering-technique. For staining, the PressX Zr powders (Bodystains + Glaze) which are components of the PressX Zr system have to be applied. For lavering, the ZIROX -- powders (a product of Wieland Dental + Technik, K051249) have to be used. PressX Zr can be pressed onto any zirconium dioxide material, which has a coefficient of thermal expansion [CTE (25-500°C]] of about 10 x 10° K'.

The provided text is a 510(k) summary for a dental device called "PressX Zr". It outlines the device description, indications for use, and a comparison with a predicate device. However, it does not contain any information about acceptance criteria, clinical studies, sample sizes, expert involvement, ground truth establishment, or specific performance metrics.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance or information about a study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device based on material properties (flexural strength, fracture resistance) and intended use, rather than presenting a clinical study with detailed performance metrics against specific acceptance criteria.

Based on the provided text, the following information is available (or explicitly not available):

1. A table of acceptance criteria and the reported device performance:
   • Not available. The document states: "Compared to the predicate device, PressX Zr has a higher flexural strength according to ISO 6872, and "standard crowns" made of PressX Zr have a significantly higher fracture resistance." However, it does not provide specific acceptance criterion values or the exact reported device performance values for these metrics. It only states they are "higher" or "significantly higher" than the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • Not available. The document does not describe a clinical study or test set in this manner. The comparison is based on material properties and general performance claims rather than a detailed 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 / Not available. No such expert review or ground truth establishment for a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   • Not applicable / Not available. No test set or associated adjudication method is mentioned.

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 device is a dental ceramic system, not an AI-assisted diagnostic tool or system that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Not applicable. This device is a dental ceramic system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • Not applicable / Not available. No ground truth for a clinical study is described. The comparison relies on material property standards (ISO 6872) and comparison to a predicate device.

8. The sample size for the training set:
   • Not applicable / Not available. The document describes a material and its manufacturing process, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   • Not applicable / Not available. As above, no training set or ground truth for it is relevant to this device description.

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