(82 days)
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:
| Acceptance Criteria (Voluntary Design Standards) | Reported Device Performance |
|---|---|
| ANSI ADA Specifications No. 69:1999 | Conformance achieved |
| ISO 6872:2008 | Conformance achieved |
| Company's Specified Design Requirements | Validation achieved |
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.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.