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The product is intended for use in fabricating oral crowns and bridges and laminate veneers and inlays for dental use.

Willi Geller Creation porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations including porcelain fused to metal crowns and bridges, laminate veneers, and inlays. The ceramic powders in the Creation porcelain system are composed in varying proportions of silicon dioxide, aluminum oxide, sodium oxide, potassium oxide, barium oxide, and iron oxide. Chemically stable mixed metal oxides, including spinel, baddeleyit, zircon, and periclase phases of zirconium, iron, cobalt, chromium, yttrium, cerium, nickel, and zinc oxides, are used in trace amounts for pigmentation. The paste opaques are comprised of ceramic powder fitting this description suspended in glycerol, zinc chloride, sodium acetate, propandiol, and aerosil. The stains are composed of silicon dioxide, aluminum oxide, tin oxide, tin oxide, barium oxide, iron oxide, and calcium oxide, and chemically stable mixed metal oxides for pigmentation. The modeling liquid is composed of zinc chloride and water. The shoulder liquid is composed of tylose and water. The glaze liquid is composed of methylethylene glycol and water. The opaque liquid is composed of zinc chloride, water, and sodium chloride. The vehicle used in the paste opaques and the liquids are evaporated during use, and are not incorporated into devices manufactured with the porcelain.

The provided text is a 510(k) clearance letter from the FDA for a dental ceramic product. It describes the composition of the product and states that it is substantially equivalent to a previously cleared device. However, it does not contain information about specific acceptance criteria for device performance, the results of a study proving those criteria were met, or any of the detailed study parameters requested in the prompt (sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, etc.).

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, nor can I describe the study that proves the device meets those criteria, as this information is absent from the provided document.

The input text is primarily a regulatory approval document and not a scientific study report.

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