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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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Dental Blanks made from StarCeram® 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® 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-Med TransColour Red is a modification to the StarCeram® products that have already been cleared by the Food and Drug Administration in K133213. StarCeram® Z-Med TransColour Red has the same intended use and fundamental scientific technology as the StarCeram® products previously cleared by FDA. The only change is the addition of a new color additive.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. No clinical or performance test set, in the traditional sense involving human or animal subjects, was used for this 510(k) submission. The performance assessment was based on laboratory testing for biocompatibility.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The ground truth for biocompatibility was established by laboratory testing against recognized international standards (ISO 10993-1 and ISO 10993-5), not by expert consensus on a test set.

4. Adjudication Method for the Test Set

Not applicable. No test set involving human interpretation or subjective assessment was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted. This device is a dental material, not an AI or imaging diagnostic device.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a dental material, not an algorithm.

7. Type of Ground Truth Used

The ground truth used for performance assessment was based on laboratory test results against recognized international standards for biocompatibility (ISO 10993-1 and ISO 10993-5).

8. Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an algorithm or AI model development. The product undergoes manufacturing and quality control processes.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There was no training set for an algorithm. The "ground truth" for the material's properties (like composition and manufacturing process) is established through adherence to material specifications and quality control procedures during manufacturing.

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Dental Blanks made from StarCeram® 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® 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.

The provided text is for a 510(k) premarket notification for a dental blank device, StarCeram®, and primarily addresses substantial equivalence to predicate devices, not performance criteria in the context of an AI/ML medical device. As such, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth is not applicable.

Here's an analysis based on the provided text, addressing the relevant points and indicating where information is not present:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as the submission does not describe a clinical study measuring device performance in the context of diagnostic accuracy or similar metrics. The "Performance Data" section explicitly states, "No performance data was required or provided." The evaluation focused on biocompatibility and substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. No test set or ground truth in the context of a diagnostic or therapeutic AI/ML device is mentioned. The assessment revolved around material properties and comparison to predicate devices.

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

This information is not applicable.

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

This information is not applicable. The device is a dental blank, not an AI/ML diagnostic or assistive tool for human readers.

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

This information is not applicable.

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

This information is not applicable. The "ground truth" in this context would be the successful demonstration of biocompatibility per ISO standards and the physical properties aligning with predicate devices, rather than a clinical ground truth for a diagnostic task.

8. The sample size for the training set

This information is not applicable. No AI/ML model training is described.

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

This information is not applicable.

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Dental Blanks made from StarCeram® Z-Med or StarCeram® Z-Al-Med HD are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

Dental blanks made of StarCeram® Z-Med or StarCeram® Z-AI-Med HD are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridge frameworks on commercial CAD/CAM systems or handoperated copy-milling machines, with outstanding biocompatibility and high resistance against tension and pressure.

Here's an analysis of the provided text regarding the acceptance criteria and study for the StarCeram device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., tensile strength greater than X, flexural strength greater than Y). Instead, it states that non-clinical testing was performed to validate the design against the company's specified design requirements and to assure conformance with two voluntary design standards.

Therefore, the "acceptance criteria" can be inferred as conformance to these standards and the company's internal design requirements.

2. Sample Size and Data Provenance for Test Set

• Sample Size: The document does not specify the sample size used for the non-clinical testing.
• Data Provenance: The document states that H.C. Starck Ceramics GmbH & Co. KG performed non-clinical testing. This suggests the data was generated internally by the manufacturer. The company is based in Selb, GERMANY, so the data provenance is likely Germany (retrospective, as it was generated before submission).

3. Number of Experts and Qualifications for Ground Truth, Test Set

This information is not applicable as the device is a material (porcelain powder) and the testing referenced is non-clinical (material property testing) rather than clinical or image-based diagnostic testing requiring expert human interpretation or ground truth establishment in a medical context.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not done. The submission explicitly states: "H.C. Starck Ceramics GmbH & Co. KG did not conduct, nor rely upon, clinical tests to determine substantial equivalence." This is a non-clinical device, not an AI or diagnostic device that would typically involve human reader studies.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study was not done. This type of study is relevant for AI algorithms or diagnostic devices. The StarCeram is a dental material, and its evaluation focuses on material properties through non-clinical testing.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily based on:

• Voluntary Design Standards: ANSI/ADA Specifications No. 69:1999 and ISO 6872:1995 + Amendment 1-1997.
• Company's Specified Design Requirements: Internal specifications for material properties and performance.

8. Sample Size for the Training Set

This information is not applicable. This device is a material, not an AI system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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