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Dental Blanks made from StarCeram® Z-Nature are indicated for crowns, multi-unit bridges, inlay bridges and all-ceramic restoration. Applications include both anterior and posterior bridges.

Dental Blanks made from StarCeram® Z-Smile are indicated for crowns and bridges, multi-unit bridges, inlay bridges and all-ceramic restoration as max three-unit bridge at the anterior and posterior area.

Dental blanks made from StarCeram® products are semi finished products made of yttrium stabilized pre-sintered zirconium dioxide for milled production of crowns and bridge framework on commercial CAD/CAM systems or hand-operated copy-milling. StarCeram® Z-Smile and StarCeram® Z-Nature are a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213 and K140924. StarCeram® Z-Smile and StarCeram® Z-Nature have the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change between the cleared products and the new products is the addition of new color qualities.

This document is a 510(k) summary for the StarCeram® Z-Nature and StarCeram® Z-Smile dental blanks. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving a device meets specific acceptance criteria through a study. Therefore, most of the requested information regarding study details (e.g., sample size, expert ground truth, adjudication, MRMC studies) is not applicable or cannot be extracted from this type of regulatory submission.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the format typically seen for a new device's performance claims. Instead, it relies on demonstrating that the new devices have similar technological characteristics and meet general standards as their predicate devices. The key performance characteristic mentioned for comparison is Flexural Strength.

Explanation of Performance:

• For StarCeram® Z-Nature, the flexural strength is identical to its predicate devices (K133213 and K140924).
• For StarCeram® Z-Smile, the flexural strength (>500 MPa) is stated to be "exactly as required by DIN EN ISO 6872 for Class 5 dental ceramics (>500MPa)", thus demonstrating equivalence to its predicate DD cubeX2 which has >720 MPa. The slightly lower value for Z-Smile is considered acceptable because it still meets the relevant standard.
• Biocompatibility and cytotoxicity were tested to ensure compliance with relevant ISO standards, aligning with the implied standards for predicate devices.

2. Sample size used for the test set and the data provenance:

• Not applicable. This document describes a 510(k) premarket notification, which typically relies on comparisons to predicate devices and adherence to recognized standards, not clinical trials with test sets in the context of AI/medical device performance evaluation.
• The "Non-clinical Testing" section mentions "Biocompatibility and cytotoxicity testing was performed," but does not provide details on sample size or data provenance (e.g., country of origin, retrospective/prospective). The study was likely conducted under Design Controls.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. No clinical test set with human subject data requiring expert ground truth or adjudication is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set.

5. 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 a material (dental ceramic blank) submission, not an AI device. No MRMC study was performed.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable for clinical ground truth. The "ground truth" in this context is adherence to recognized standards for material properties (e.g., Flexural Strength, biocompatibility), which are measured through laboratory testing, not human-derived ground truth.

8. The sample size for the training set:

• Not applicable. This is a material device, not an AI device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. As above, no training set.

In summary:

This 510(k) submission primarily demonstrates "substantial equivalence" based on:

• Similar intended use and indications for use.
• Similar fundamental scientific technology (yttrium stabilized pre-sintered zirconium dioxide).
• Similar technological characteristics and performance specifications (e.g., flexural strength meeting or exceeding relevant ISO/DIN standards, biocompatibility testing in compliance with ISO standards).
• The key change for these new products (StarCeram® Z-Nature and Z-Smile) compared to their predicates is "the addition of new color qualities."
• "No clinical testing was performed" for this submission, as the changes were deemed not to warrant new human clinical studies given the existing predicate data and adherence to material standards.

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