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Trilor Fiber Disks, Blocks and Arches are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers. They are intended to be used technicians and dentists for making only copings, substructures or frameworks for permanent and transitional anterior or posterior crowns, bridgework and substructures that can be for either cemented or uncemented restorations e.g., telescopic restorations.

Trilor Fiber Disks, Blocks and Arches are milling blanks composed of a multi-directional interlacing of fiberglass and resin in several layers.

The provided text is a 510(k) clearance letter from the FDA for a dental restoration material named "Trilor Fiber Disks, Blocks, and Arches." This document is a regulatory communication, not a study report or clinical trial summary. As such, it does not contain the specific information required to complete your request regarding acceptance criteria and performance studies for a device.

The letter acknowledges the substantial equivalence of the "Trilor Fiber Disks, Blocks and Arches" to a predicate device based on its intended use as a "Tooth Shade Resin Material," but it does not detail any performance studies, acceptance criteria, or ground truth establishment that would be part of a clinical evaluation for a diagnostic or AI-powered device.

Therefore, I cannot provide the requested information from the given text.

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