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The GR-17 Resin System is a light-curable resin intended to be used in conjunction with extra-oral curing light equipment.

The GR-17 temporary is indicated for the fabrication, by additive manufacturing, of temporary anterior dental restorations.

The GR-17.1 temporary is indicated for the fabrication, by additive manufacturing, of temporary dental restorations, and for the fabrication, by additive manufacturing, of preformed denture teeth to be used in a denture.

GR-17 Resin System includes the GR-17 temporary and GR-17.1 temporary It and is made of functional methacrylic resins and inorganic fillers with particle sizes from 0.4 to 3 microns. It is available in seven shades based on the shade guide, A1, A2, A3, A3.5, B1, B2 and bleach. The resin is a liquid photo-curable material that is polymerized by image projection systems at 405nm to create temporary dental restorations, and preformed denture teeth to be used in a denture. The GR-17 Resin System 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 document is a 510(k) summary for the GR-17 Resin System, a temporary crown and bridge resin. It describes the device's characteristics and compares it to predicate and reference devices to demonstrate substantial equivalence. However, this document does not contain the detailed information required to describe acceptance criteria and the study that proves the device meets those criteria, specifically concerning performance metrics for an AI/algorithm-based device.

The document mentions "Performance testing for the GR-17 Resin System was performed in accordance with ISO 10477 and ISO 22112" and lists "Flexural Strength," "Modulus of Elasticity," "Water Absorption," and "Solubility" as physical and mechanical properties. This indicates testing for the material properties of the resin itself, not the performance of an AI/algorithm-based device.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/algorithm, sample sizes for test/training sets, expert qualifications, adjudication methods, or MRMC studies, as these types of studies are not described in this regulatory submission for a dental resin.

The document covers a physical medical device (dental resin) and not an AI/algorithm device. Therefore, the specific questions about AI/algorithm performance metrics, sample sizes for AI tests, expert adjudication, MRMC studies, and standalone performance for AI are not applicable to the content provided.

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