(76 days)
For use as a milling blank in the fabrication of provisional crowns and bridges.
Discs of PMMA in two sizes and three shades for milling into provisional crowns and bridges
The provided text describes a 510(k) premarket notification for a dental device, specifically a "Wieland Zeno CAO temporary PMMA disc, tooth-colored." This device is a material for fabricating provisional crowns and bridges, not an AI/ML powered device. As such, the concept of "acceptance criteria for an AI device" and the associated study characteristics (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to the information provided in this document.
The document states that the device was tested for compliance to ISO 3336 and ISO 10993. These are standards for dental materials and biocompatibility, respectively. The acceptance criteria would be defined by these ISO standards, and the "study" would be the testing performed to demonstrate compliance with these material properties and safety standards.
Therefore, I cannot fulfill the request as formatted for an AI/ML powered device using the given text. The information required (e.g., number of experts, adjudication methods, AI performance metrics) is simply not present because the device is a physical dental material and not a software-based diagnostic or analytical tool.
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.