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Hard Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.

Thermo-adaptive Splint is a 3D print light curable resin for the fabrication of orthodontic and dental appliances such as splints, mouthguards, nightguards, repositioners and retainers.

Whip Mix Dental Resin is light cured resin that is provided in a plastic container, and it is a proprietary blend of ingredients that make a generative resin. When the system (which includes a scanner, design software, printer software, resin, 3D printer, and curing unit) are used in combination, the result is an additive manufactured orthodontic, thermo-flexible orthodontic, or dental appliances such as mouthguards, splint, nightguards, repositioners and retainers.

The provided text describes a 510(k) premarket notification for two light-curable resins, "Hard Splint" and "Thermo-Adaptive Splint," for fabricating dental appliances. It mainly focuses on the substantial equivalence to predicate devices based on technological characteristics and non-clinical tests. However, it does not contain information related to software performance, AI algorithms, human-in-the-loop studies, or the acceptance criteria for such systems.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to AI or software, nor can I answer questions about sample sizes for test sets, data provenance, expert-established ground truths, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This document pertains to the material properties and biocompatibility of the resins, not the performance of a diagnostic or analytical device with acceptance criteria involving sensitivity, specificity, or other performance metrics typically associated with AI.

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