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Willi Geller Creation TI Porcelain is a ceramic material intended for veneering of titanium alloy cores and substructures to form dental restorations.

Williw Geller Creation TI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of titanium alloy cores. Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain. The safety and effectiveness of Willi Geller Creation TI , being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices.

The provided document, K043468, is a 510(k) summary for a dental porcelain device. It focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties, chemical qualities, and indications for use.

Therefore, the document does not contain information on the following:

• Acceptance criteria or reported device performance in a table format for a diagnostic or AI device.
• Sample sizes, data provenance, or details about test sets.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Types of ground truth (e.g., pathology, outcomes data).
• Sample size for training sets or how ground truth was established for training sets.

Instead, the document states:

Acceptance Criteria and Study:

The acceptance criteria for "Willi Geller Creation TI Porcelain" were based on demonstrating substantial equivalence in:

• Mechanical properties
• Chemical qualities
• Indications for use

The study performed to prove the device meets these acceptance criteria was a comparison to a predicate device, Willi Geller Creation& LF Porcelain (K00290). The submission asserts that "Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation TI substantially equivalent to the predicate device Willi Geller Creation& LF Porcelain."

The safety and effectiveness of "Willi Geller Creation TI" were determined by these chemical qualities and mechanical properties, making it equivalent to the predicate devices.

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Willi Geller Creation ZI Porcelain is a ceramic material intended for the veneering of zirconium oxide based cores and substructures to form dental restorations

Williw Geller Creation ZI porcelain is a dental ceramic that is used by dental technicians to fabricate dental restorations by veneering of zirconium oxide-based cores.

This document (K043201) describes a dental porcelain device, not an AI/ML powered medical device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and AI-specific metrics cannot be extracted.

The document primarily focuses on establishing substantial equivalence for the "Willi Geller Creation ZI Porcelain" with predicate devices based on its mechanical properties, chemical qualities, and indications for use as a dental ceramic for veneering zirconium oxide-based cores.

No information regarding acceptance criteria for an AI/ML powered medical device, study design for performance evaluation, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies is present in the provided text.

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Willi Geller Creation CP Porcelain is a pressable ceramic material intended for constructing veneer, onlay, inlay, and crown substructures and full contour restorations. Veneering of substructures can be performed with suitable conventional or low fusing porcelains such as Willi Geller Creation GC or Willi Geller Creation LF (K02904).

Willi Geller Creation CP porcelain consists of pressable ceramic pellets that are used by dental technicians to fabricate full contour restorations (crowns, onlays, inlays, veneers) and substructures for full ceramic demtal restorations that are completed by being veneered with conventional or low fusing dental porcelains.

This document, K043221, is a 510(k) Pre-market Notification for a dental porcelain product called "Willi Geller Creation CP Porcelain." As such, it does not contain the kind of study information you are asking for, which is typical for diagnostic medical devices or those with more complex performance claims. This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on mechanical properties, chemical qualities, and indications for use, rather than clinical performance metrics like sensitivity, specificity, or reader studies.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details from the provided text.

The document states: "Data has been presented to demonstrate that the mechanical properties, chemical qualities, and the indications for use make Willi Geller Creation CP substantially equivalent to the predicate device Match Press pressable ceramic. The safety and effectiveness of Willi Geller Creation CP, being determined by the chemical qualities and mechanical properties, is therefore equivalent to the predicate devices."

This implies that the "study" for this device involved comparing its physical and chemical properties to those of the predicate device (Match Press pressable ceramic, K024250) to establish substantial equivalence. However, the details of these comparisons (e.g., specific tests, acceptance criteria, results) are not included in the provided 510(k) summary.

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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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