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Radiance Porcelain is a sodium/potassium alumina silicate leucite glass ceramic porcelain system for the fabrication of dental restorations, crowns, bridges, veneers, inlays, and onlays, using either dental alloys or its pressable component, Press-I-Dent.

This porcelain system is a lower fusing porcelain than feldspar based porcelains and is manufactured from the fritting of manufactured glass compositions. In addition, it has lower opposing occlusal wear characteristics than feldspar based porcelains.

Radiance is intended for use by dental laboratories as an alternative to other porcelains.

Radiance Porcelain system is a sodium/potassium alumina silicate based leucite glass ceramic, porcelain system for the fabrication of either porcelain fused to metal or all ceramic restorations. Radiance porcelain can only be used with its corresponding leucite glass ceramic pressable, Press-I-Dent for the fabrication of all ceramic systems and therefore constitute one complete porcelain system.

The provided text is a 510(k) summary for the Radiance Porcelain device, which is a dental material. It describes the device, its intended use, and its technological characteristics in comparison to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets such criteria in terms of performance metrics like accuracy, sensitivity, or specificity.

The document states:

• "All the components in the Radiance System have been used in legally marketed devices."
• "This system has been on the European market since 1999 and enjoys full CE marking from the manufacturer."
• "Because of the similarities between the Radiance System and the predicated devices, we felt that no further biocompatibility testing was necessary."
• "Radiance Porcelain is a sodium/potassium alumina silicate leucite glass ceramic porcelain system for the fabrication of dental restorations, crowns, bridges, veneers, inlays, and onlays, using either dental alloys or its pressable component, Press-I-Dent."
• "This porcelain system is a lower fusing porcelain than feldspar based porcelains and is manufactured from the fritting of manufactured glass compositions. In addition, it has lower opposing occlusal wear characteristics than feldspar based porcelains."

This indicates that the FDA's substantial equivalence determination for this device was based on similarity to legally marketed predicate devices and existing market history in Europe, not on a performance study against specific acceptance criteria. The document highlights "lower opposing occlusal wear characteristics" as an additional feature compared to feldspar-based porcelains but doesn't provide specific quantitative data or a study design to support this.

Therefore, I cannot populate the requested table and answer the study-related questions for this document because the information is not present. The provided text is a regulatory submission focused on demonstrating substantial equivalence based on material composition and intended use similar to existing products, rather than a detailed performance study with acceptance criteria.

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