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The Cyrtina system is intended for CAD/CAM fabrication of allceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

The CYRTINA SYSTEM is intended to fabricate all-ceramic dental devices like definite crowns and bridges. The Cyrtina System consists of two different materials: Cyrtina® BioZyram® is a core material made of zirconia. It is provided as green, shaded hexblocks especially developed for processing for milling at Cyrtina® Center. The five shades are combined with the grouped Cyrtina® Ceram shades. Sakura® Interaction is an all-ceramic overlay material in powder form developed for veneering Cyrtina® BioZyram® substructure by layering to provide esthetics and characterization for fixed prosthodontic devices that include both anterior and posterior crowns/bridges and for implant abutments. Sakura® Interaction consists of Liner/Dentin/Transparent/Incisal all-ceramic veneering material. The final restoration shade matches 16 Vita Lumen shades and four Bleach shades. Cyrtina® dental restorations are fabricated according to a dental impression which is scanned into a computing device. By CAD/CAM technology unfashioned zirconia blocks of Cyrtina® BioZyram® are milled in Cyrtina® Center. After the dental appliance has been milled the piece is sintered at a temperature of 1400°C. For esthetic reasons, the ceramic crown, bridge or abutment, resp. is veneered by Sakura® Interaction.

This document is a 510(k) summary for the Cyrtina® BioZyram® Sakura® Interaction dental material system. It focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria or conducting a comprehensive study with clinical efficacy endpoints a medical device that uses AI might. As such, many of the requested categories related to AI-driven device studies are not applicable or cannot be extracted from the provided text.

Here is the information that can be extracted or inferred from the provided document:

Acceptance Criteria and Device Performance

For this type of device (dental ceramic), performance is typically assessed by comparing physical and mechanical properties to established predicate devices. The document states: "To provide evidence for the effectiveness of the Cyrtin® system, the physical and mechanical properties have been compared to predicate devices."

Study Details (as applicable to a 510(k) for dental materials):

1. Sample size used for the test set and the data provenance: Not explicitly stated for specific tests (e.g., biocompatibility, physical properties). The context of a 510(k) for dental materials suggests that standard material testing was performed, but the sample sizes for those tests are not detailed. The device has been on the European market since 2000 with "over twenty thousand units placed," implying extensive real-world usage data, but this is not presented as a formal "test set" for a specific study in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. For material performance, "ground truth" is typically established by established ASTM/ISO standards and laboratory measurements, not expert consensus in the way an AI diagnostic device would require.

3. Adjudication method for the test set: Not applicable.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-driven or diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a dental material system.

6. The type of ground truth used:

   • Biocompatibility: Likely established through standardized in vitro and/or in vivo tests according to ISO standards, with results compared to established safety profiles.
   • Physical and Mechanical Properties: Established through laboratory measurements following recognized material testing standards (e.g., ISO, ASTM) and comparison to predicate devices.

7. The sample size for the training set: Not applicable. This is a material system, not an AI model requiring a training set.

8. How the ground truth for the training set was established: Not applicable.

Summary of Conclusions from the Document:

The predicate devices mentioned (LAVA Frame, Denzir, DCZirkon, Willi Geller Creation Porcelain, OPC 3G All-ceramic system, IPS Empress 2, Cercon Ceram Porcelain, KATANA Zirconia) demonstrate similar technological characteristics and intended use. The 510(k) summary argues for substantial equivalence based on:

• The fact that all chemical ingredients for the core material and veneer are already contained in predicate devices.
• Biocompatibility test results showing the device is safe.
• Comparison of physical and mechanical properties to predicate devices, demonstrating effectiveness.
• Historical use of the device in Europe since 2000 (over twenty thousand units placed).

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination implies that the provided data (including the material comparisons and biocompatibility) met the FDA's requirements for marketing this type of device.

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