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PlatinLloyd 100 is a crown and bridge type 4 casting alloy. It is a medical device in accordance with Regulation 95712 BBC. Guarder segulaiton requirements are met.

AuroLloyd KF

The provided FDA 510(k) clearance letter and associated documents for the "AuroLloyd® KF" device (K983080) do not contain information about acceptance criteria or a study proving the device meets specific performance metrics.

The documents indicate that the device, "PlatinLloyd 100," is a crown and bridge type 4 casting alloy and is being cleared based on its substantial equivalence to a legally marketed predicate device. The clearance is based on the device meeting CE seal requirements in accordance with Regulation 957/2 BBC (which seems to be a European regulation, potentially 93/42/EEC concerning medical devices or a similar standard, given the context of "Annex IX and CE seal").

Therefore, I cannot provide the requested information as it is not present in the given text. The FDA 510(k) process for substantial equivalence often relies heavily on comparison to an existing predicate device rather than demanding new clinical trials with detailed performance criteria and statistical studies for certain classes of devices, especially materials like dental alloys.

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