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DD Bio Z-dental blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both anterior and posterior bridges.

Dental milling blanks made of DD Bio Z, DD Bio ZX 2 , DD Bio ZX 2 color are semi-finished products out of yttrium-stabilized, pre-sintered zirconium dioxide for the fabrication of crown- and bridge- frameworks on commercial CAD/CAM systems or hand-operated copy-milling machines, with outstanding biocompatibility and mechanical properties.

This document, a 510(k) submission for dental milling blanks (DD Bio Z, DD Bio ZX2, DD Bio ZX2 color), focuses on demonstrating substantial equivalence to a predicate device (K093748: DD Bio Z, DD Bio Z transpa) rather than establishing novel safety and effectiveness through a comprehensive study with acceptance criteria.

Therefore, many of the requested categories are not applicable or not explicitly stated in this type of regulatory document. I will fill in the available information and explicitly state when information is not provided.

Acceptance Criteria and Device Performance for DD Bio Z, DD Bio ZX2, DD Bio ZX2 color

This submission is a 510(k) premarket notification, which seeks to demonstrate "substantial equivalence" to a legally marketed predicate device, as opposed to proving de novo safety and effectiveness through clinical trials with defined acceptance criteria. The primary method of demonstrating equivalence here is through non-clinical testing to voluntary design standards and comparison of material properties.

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

The document does not explicitly present "acceptance criteria" in the typical sense of a clinical study endpoint. Instead, it relies on conformance to a voluntary design standard (ISO 6872:2008) and comparison of key material properties to the predicate and to the intended use. The performance reported below focuses on the material specifications as compared to the predicate.

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

• Sample Size for Test Set: Not explicitly stated in terms of number of devices/cases tested for each specific property. The submission refers to "testing of the materials to the biocompatibility requirements of design standard ISO 6872:2008" and "non-clinical testing... to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary design standard: ISO 6872:2008." The specific methodology or sample sizes for these tests are not provided in this summary.
• Data Provenance: Not specified in the provided summary. However, the submitter is "Dental Direkt of Amerika UG (haftungsbeschraenkt)" located in Germany, suggesting testing may have been conducted there or by affiliated accredited laboratories.

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)

Not applicable. This is a material science and biocompatibility assessment, not a diagnostic imaging study requiring expert interpretation for "ground truth." The "truth" is established by laboratory measurements against defined standards.

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

Not applicable. There is no human adjudication process described, as this is related to material properties and biocompatibility testing against objective standards.

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 device is a dental milling blank (a material), not an AI-powered diagnostic tool.

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

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

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

The "ground truth" for the material properties and biocompatibility is established by:

• Physical and Chemical Measurements: Laboratory tests against established material science parameters (e.g., flexural strength, chemical composition).
• Standard Conformance: Adherence to recognized international standards such as DIN EN ISO 10993-1, ISO 10993-5 (biocompatibility), and ISO 6872:2008 (dental ceramic specifications).

8. The sample size for the training set

Not applicable. This device is a physical material, not an AI algorithm requiring a training set.

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

Not applicable.

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Dental Blanks made from DD Bio Z or DD Bio Z-transpa are indicated for crowns, multiunit bridges and inlay bridges. Applications include both anterior and posterior ridges.

Dental Blanks made of DD Bio Z or DD Bio Z-transpa are dental materials (semifinished products) made of yttrium stabilized, presintered zirconium dioxide for milled production of crowns and bridges frameworks on commercial CAD/CAM systems or handoperated copy-milling machines. machines with outstanding biocompatibility and high resistance against tension and pressure.

The provided document describes a 510(k) premarket notification for a dental device, specifically "DD Bio Z, DD Bio Z-transpa" porcelain powders. This is a medical device submission for regulatory clearance, not a study reporting on the performance of an AI or diagnostic device in the way your questions typically expect.

Therefore, many of your requested fields, such as "sample size used for the test set," "number of experts used," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set sample size/ground truth," are not applicable to this document. This document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and verification against design standards, rather than clinical efficacy or diagnostic accuracy studies.

Here's the information that can be extracted or inferred from the document:

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

Study Proving Device Meets Acceptance Criteria:

Dental Direkt of Amerika UG (haftungsbeschraenkt) performed non-clinical testing to validate the design against their specified design requirements and to assure conformance with the voluntary design standards ANSI ADA Specifications No. 69:1999 and ISO 6872:2008. The document does not provide specific test results or data but states that these tests were conducted and conformance/validation was achieved.

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

• Sample Size: Not specified.
• Data Provenance: The testing was conducted by Dental Direkt of Amerika UG (haftungsbeschraenkt) in Spenge, Germany. It was non-clinical testing.

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

• Not Applicable. Ground truth, in the context of clinical or diagnostic accuracy, is not relevant here as it's a non-clinical, material properties assessment for substantial equivalence.

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

• Not Applicable. Adjudication is not relevant for materials testing against engineering standards.

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:

• No. This is a dental material, not an AI or diagnostic imaging device.

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

• No. This is a dental material, not an algorithm.

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

• Not Applicable. The "ground truth" equivalent would be the objective measurements and properties defined by the ANSI ADA and ISO standards for dental ceramics.

8. The sample size for the training set:

• Not Applicable. This is a dental material, not a machine learning model.

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

• Not Applicable.

Additional Notes from the document:

• Clinical Testing: The submitter explicitly stated, "Dental Direkt of Amerika UG (haftungsbeschraenkt) Testing did not conduct, nor rely upon, clinical tests to determine substantial equivalence."
• Technological Characteristics: The submitter claims that the technological characteristics between the proposed device and predicate devices are identical, and there is "no difference in fundamental scientific technology." They are made from the same materials and have the same intended use.
• Risk Management: A risk management program according to ISO 14971 was applied.

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