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Porcelain fused to metal for dental use.

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I am sorry, but the provided text is a 510(k) summary for a dental porcelain device. It is a regulatory document from the FDA outlining the substantial equivalence determination for "Zeo CE Light and Zeo Quick Porcelain."

This document does not contain information regarding:

• Acceptance criteria and reported device performance.
• Sample sizes, data provenance, or expert qualifications for a study.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Types of ground truth used.
• Training set sample sizes or how ground truth for training sets was established.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice and does not include the details of a performance study.

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Acrylic teeth to be used for construction of full and partial dentures by a dental professional. Dentures are removable, not implanted in patients' mouths.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving device performance. The document is a 510(k) clearance letter from the FDA for a device called "Wiedent Esthetic Teeth."

This type of letter primarily focuses on:

• Substantial Equivalence: It states that the device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.
• Regulatory Classification: It clarifies the device's regulatory class and product code.
• Compliance Requirements: It reminds the manufacturer of their ongoing responsibilities under the Federal Food, Drug, and Cosmetic Act.

The document does not include:

• Specific acceptance criteria for the device's performance (e.g., tensile strength, wear resistance, color stability).
• Details of any performance studies conducted to meet such criteria.
• Information on sample sizes, data provenance, expert qualifications, ground truth establishment, or comparative effectiveness studies.

Therefore, I cannot populate the table or provide the requested study details from the text you provided.

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