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P1145, a nanohybrid dental restorative, is indicated for direct placement in all cavity classes in anterior and posterior teeth. Additional indications include: repair of enamel defects, repair of provisionals, repair of porcelain restorations, minor occlusal build-ups, core build-ups and incisal abrasions.

P1145 is a light-cured, esthetic, resin-based nanohybrid dental restorative designed for direct placement in both anterior and posterior restorations. It is designed to be used after placement of a dental adhesive. Once placed, the composite can be easily sculpted to the desired shape, and after curing, can easily be finished and polished to achieve a highly esthetic restoration.

The provided text is a 510(k) premarket notification for a dental restorative device (P1145 Dental Restorative). It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (Herculite Ultra).

However, the document does not describe acceptance criteria for an AI/algorithm-based device, nor does it detail a study proving such a device meets acceptance criteria.

The "Non-Clinical Performance Data" section refers to tests for a conventional dental material (mechanical strength, polishability, water sorption, etc.) against established standards like ISO 4049:2009. These are physical and chemical property tests for the restorative material itself, not performance metrics for an AI or algorithm.

Therefore, I cannot extract the information required for the prompt as it pertains to an AI/algorithm-based device and its performance study. The document is about a physical dental material, not a digital diagnostic or prognostic tool.

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