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The Razor and Everest are indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior location.

U&C Liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

Razor and Everest are zirconia-based ceramic provided in various shapes such as round and square, and they are used to manufacture cores of all ceramic crowns, and are classified into ISO 6872 Type 2 Class 5.

They are used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers 31 different shades A0, A1, A2, A3, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, ML A1, ML A2, ML A3, ML A4, ML B1, ML B2, ML B3, ML B4, ML C1, ML C2, ML C3. ML C4. ML D2. ML D3. ML D4 to meet the needs of different patients' tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.

U&C Liquid is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 25 shades. 25 shades are available in 30ml, 50ml and 100ml volumes.

The provided document is a 510(k) Pre-market Notification from the FDA regarding dental devices (Razor, Everest, U&C Liquid), primarily focused on demonstrating substantial equivalence to existing predicate devices. It does not describe a study involving an AI/algorithmic device and its acceptance criteria or a study proving its performance.

The document pertains to traditional dental materials (zirconia-based ceramics and liquid stains) for fabricating dental restorations. There is no mention of "AI," "algorithm," "human readers," "ground truth," "MRMC study," or any other terminology typically associated with the evaluation of AI-powered medical devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance study for an AI device from this document. The prompt's request for tables of acceptance criteria, sample sizes for AI test/training sets, expert adjudication methods, MRMC studies, or standalone algorithm performance is not applicable to the content provided in the FDA 510(k) submission for these dental materials.

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