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HI-Wave is a 3 minutes microwave heat curing acrylic and Pour-Plus is a color stable auto-curing acrylic for use in the fabrication of complete or partial removable dentures.

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The provided text is a 510(k) clearance letter from the FDA for two dental devices, "Hi-Wave" and "Pour-Plus" denture base acrylics. It does not contain any information regarding acceptance criteria, device performance, sample sizes used in studies, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table or answer the specific questions about the device's acceptance criteria and the study proving it meets those criteria. The document only states that the devices are substantially equivalent to legally marketed predicate devices.

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IMPACT-PLUS, IMPACT-20, DP97, DP97-20 are heat-cure acrylics for complete and partial denture fabrication. DP-POUR is auto-cure acrylic for complete and partial denture fabrication. DP-REPAIR is auto-cure acrylic for denture repair.

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The provided document is a 510(k) premarket notification letter from the FDA, along with an "Indications for Use" statement, for dental acrylics. It does not contain any information regarding acceptance criteria, study details, device performance metrics, or ground truth establishment for an AI-powered medical device.

Therefore, I cannot answer your request based on the provided input. The document is a regulatory approval for a physical product (dental acrylics) and not a study report or technical specification for an AI device.

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