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It is a gold / Platinum porcelain-to-metal alloy with high strength and hardness. It is suitable for longspans and bridges. It is a high noble alloy and it enhances the esthetic qualities of the finished porcelain restoration. It is compatible with a wide range of porcelains.

It is a gold / Platinum porcelain-to-metal alloy with high strength and hardness.

This document is a 510(k) clearance letter from the FDA for a dental alloy named "Jel-71 PdF." It states that the device is substantially equivalent to legally marketed predicate devices. However, this type of document does not contain details about specific acceptance criteria, study designs, or performance metrics in the way you are requesting for a device evaluation.

510(k) clearances are primarily based on demonstrating substantial equivalence to a predicate device, not necessarily on new clinical performance data or effectiveness studies that quantify improvement with AI, for instance. The focus is often on comparing material properties, biocompatibility, and intended use against existing devices.

Therefore, I cannot provide the detailed information you requested about acceptance criteria and a study proving device performance because this information is not present in the provided FDA 510(k) clearance letter or its accompanying Indications for Use statement.

The document only provides:

• Device Name: Jel-71 PdF
• Product Code: EJT
• Regulatory Class: II
• Indications For Use: "It is a gold / Platinum porcelain-to-metal alloy with high strength and hardness. It is suitable for long-spans and bridges. It is a high noble alloy and it enhances the esthetic qualities of the finished porcelain restoration. It is compatible with a wide range of porcelains."

To get the kind of detailed information you're asking for (acceptance criteria, specific study design, sample sizes, ground truth establishment, AI assistance, etc.), you would typically need to refer to specific premarket approval (PMA) applications, detailed study reports, or scientific publications related to the device, which are not included in this 510(k) response.

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