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Types of restorations:

1. Anterior and posterior crowns
2. Veneers, inlays, onlays.

zirconia layering porcelain system layering ceramic powders and pastes are used in dental laboratories by the dental technician to create ceramic restorations.

The provided FDA 510(k) clearance letter and summary are for "zirkon; structure; LFU shades, stains and glazes," which are dental ceramic materials (porcelain powder for clinical use), not a medical device that relies on an algorithm or AI for diagnostic or treatment assistance. Therefore, the document does not contain any information regarding acceptance criteria related to device performance in the context of AI/algorithm a medical device, nor does it describe a study to prove such performance.

The "acceptance criteria" and "study" described in the input prompt are typically associated with AI/ML-based medical devices or diagnostic tools where performance metrics like sensitivity, specificity, or reader improvement are critical for demonstrating safety and effectiveness.

The information provided in the FDA document focuses on the equivalence of the dental ceramic materials to a predicate device based on:

• Intended Use: Types of dental restorations (crowns, veneers, inlays, onlays).
• Technological Characteristics: Physical state (powder/paste), material composition (silicate glass ceramics), and classification according to ISO 6872:2019.
• Bench Testing: Compliance with physical properties (flexural strength, chemical solubility, thermal expansion, glass transition temperature, radioactivity) and biocompatibility according to ISO 7405:2018 and ISO 10993:2018.

Therefore, it is impossible to extract the requested information (table of acceptance criteria with device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from the provided text, as these concepts are not applicable to the type of device described.

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