(419 days)
The printodent® GR-10 guide | MSI is a light-curable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of orthodontic and dental objects such as splints.
The printodent® GR-19.1 OA is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extraoral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
The printodent® GR-19.1 OA | MSI is a light-curable polymerizable resin intended to be used in conjunction with extra-oral curing light equipment for the fabrication, by additive manufacturing, of dental objects such as mouthguards, nightguards, splints, repositioners and retainers.
GR-10 guide MSI is made of functional methacrylic resins and inorganic fillers and the GR-19.1 OA, and GR-19.1 OA MSI consist of functional (meth)acrylic resins, initiators, dyes, stabilisers and lactam.
The GR-10 guide MSI, and GR-19.1 OA MSI are available in ocean blue shade, and the GR-19.1 OA is available in clear transparent. The resin is a liquid photo-curable material that is polymerized by image projection systems at ≤ 405 nm to create dental appliances. The GR Resin System MSI is intended to be used in conjunction with an additive Computer-Aided Manufacturing (CAM) and curing system such as Nyomo, Rapidshape, Envisiontec or Asiga Systems
The provided text describes a 510(k) premarket notification for a GR Resin System MSI, a light-curable polymerizable resin used for fabricating orthodontic and dental objects. However, it does not contain information about a study proving the device meets acceptance criteria related to artificial intelligence (AI) performance, human reader improvement with AI assistance (MRMC), or standalone algorithm performance.
This document focuses on demonstrating substantial equivalence to predicate devices based on indications for use, chemical composition, manufacturing technology, physical state, curing method, and compliance with performance, biocompatibility, and shelf-life standards. The "Performance Testing" section only states that testing was performed in accordance with ISO 20795-2 for Flexural Strength, Flexural modulus / Bending module, Water Sorption, and Solubility.
Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/human-in-the-loop device, as the provided text pertains to a different type of medical device (a dental resin).
To answer your request, I would need a document describing the study and acceptance criteria for an AI-powered medical device.
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