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HCG Zirconia Ceramic Block are intended for the fabrication of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.

"HCG Zirconia Ceramic Block" is a ceramic block composed of zirconia compounds. It is suitable for manufacture of dental crowns and bridges cut in the conventional manner or with the help of CAD/CAM.

The provided text describes the 510(k) summary for the HCG Zirconia Ceramic Block, which is a dental device. The information details non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for an AI/ML-driven medical device.

Therefore, the document does not contain the requested information regarding:

• A table of acceptance criteria and reported device performance for an AI/ML device.
• Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or how ground truth for training data was established.

This document focuses on the physical and chemical properties, biocompatibility, and functional testing of a zirconia ceramic block against established standards (e.g., ASTM, ISO) to demonstrate its equivalence for dental restorations. It explicitly states: "No clinical test data was used to support the decision of substantial equivalence."

In summary, this document is not a study proving an AI/ML device meets acceptance criteria. It is a submission for a dental material (zirconia block) based on non-clinical performance and substantial equivalence to existing predicate devices.

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