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The DCceram System is used to fabricate prostheses for missing/damaged teeth. The DCceram pressable ceramic ingots are pressed onto metal alloy (DCceram 12.5) or zirconia (DCceram 9.2) frames by dental technicians to fabricate ceramic restorations. DCceram 12.5 and DCceram 9.2 ceramic layering porcelains and shades are used to layer or build up the pressed ceramic to final tooth morphology and shade on the particular framework (DCceram 9.2 zirconia substructures; Dcceram 12.5 metal substructures). The DCceram conceptPress ceramic ingots are used to fabricate all-ceramic restorations. DCceram conceptArt ceramic stains and shades may be used with DCceram conceptPress or DCceram 9.2 ceramics.

The DCceram System consists of several silica glass ceramic materials used to create ceramic and/or metal-ceramic dental prosthetic dental restorations, including inlays, onlays, veneers, crowns and bridges. The DCceram System components are available in a wide range of tooth shades (A1 – D4) as well as special shades. All DCceram System materials meet the physical properties requirements defined in ISO 6872:2008 Dentistry - Ceramic Materials, and are biocompatible as defined in ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.

The DCceram System components are:

• DCceram 9.2 & 12.5 pressable porcelain ingots
• DCceram conceptPress porcelain ingots
• DCceram9.2 liner/layering porcelain
• DCceram 12.5 liner/layering porcelain
• DCceram12.5 stains and shades
• DCceram conceptArt stains, shades and glazes

The DCceram9.2 and 12.5 ingots are silicate glass-based ceramic materials designed to create dental restorations using a lost wax technique in a vacuum press. DCceram 9.2 ingots are used with zirconia frameworks; DCceram 12.5 is compatible with metal (dental alloy) frameworks. The DCceram conceptPress ingots are used to create all-ceramic dental restorations. The complete DCceram System also includes a full line of compatible liner, build-up, layering and veneering ceramics. All system materials are available in a range of tooth shades.

The provided text describes the DCceram System, a dental ceramic product, and its FDA 510(k) submission. However, it does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a specific study proving device performance against those criteria in the context of an AI/human reader study.

The document is a US FDA 510(k) clearance letter and summary for a dental ceramic system, not an AI/Software as a Medical Device (SaMD). The testing described focuses on material properties of the dental ceramic, not the performance of an AI algorithm or human reader accuracy.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document in the context of AI or human reader studies. Similarly, I cannot answer questions 2 through 9 as they pertain to AI/SaMD studies, which are not described in this document.

Here's what the document does provide regarding acceptance criteria and testing for the dental ceramic device:

The device's performance is evaluated against international standards for dental ceramic materials.

Acceptance Criteria and Reported Device Performance (as pertains to the ceramic material):

Details on the "Study" (Material Testing) that Proves the Device Meets Acceptance Criteria:

1. Specific Tests Conducted (relevant to the ceramic material):

   • Coefficient of Thermal Expansion (CTE)
   • Transformation Temperature
   • Bending Strength
   • Chemical Solubility
   • Radioactivity
   • For DCceram conceptPress porcelain ingots (Type II, Class 4b, per ISO 6872):
     • Weibull strength/modulus
     • Fracture toughness
     • Martens hardness
   • Cytotoxicity testing (ISO 10993-5)

2. Sample size used for the test set and the data provenance: Not specified in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This is material testing, not expert-adjudicated performance.

4. Adjudication method: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable for this type of device and submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable.

7. The type of ground truth used: International standards (ISO 6872, ISO 7405, ISO 10993-5) define the "ground truth" for material properties and biocompatibility. The results of physical and chemical tests are compared against the limits set by these standards.

8. The sample size for the training set: Not applicable. This is not a machine learning device.

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

In summary, the provided document is for a dental ceramic material, and the "acceptance criteria" and "study" relate to showing the material meets established physical, chemical, and biocompatibility standards, not the performance of an AI algorithm or human reader.

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