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DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges.

DD cube ONE ML are dental milling blanks made of yttria-stabilized pre-sintered zirconium dioxide, showing a super high translucency and a high strength and fracture toughness at the same time. The ceramics are of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-223). The material is suited ideally for crowns and bridges for both, the anterior and posterior region.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: DD cube ONE ML (Dental Zirconia Blanks)
Predicate Device: K170885: Dental Direkt GmbH DD cube ONE (former DD cubeX2 HS)

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample size used for the non-clinical tests (physical/chemical properties). It mentions that "DD cube ONE ML products were tested by an accredited testing laboratory" but doesn't specify how many samples were tested for each criterion.
• Data Provenance: The tests were performed by an "accredited testing laboratory." The country of origin of this laboratory is not specified. The tests are "non-clinical tests," implying a laboratory setting rather than patient data. The study is not a clinical study, so terms like "retrospective" or "prospective" are not applicable in that context.

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

• This information is not applicable as the provided study is a non-clinical, laboratory-based testing report for material properties (physical and chemical), not a diagnostic or AI-assisted clinical device requiring expert ground truth for interpretation. Visual inspections were performed, but no specific "experts" or their qualifications are detailed beyond the testing laboratory's accreditation.

4. Adjudication Method for the Test Set

• This information is not applicable for the same reasons as #3. The evaluation of physical and chemical properties in a laboratory setting typically does not involve adjudication by multiple experts in the sense of clinical image review.

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

• No, an MRMC comparative effectiveness study was not done.
• The device is "Porcelain Powder for Clinical Use" (specifically, dental zirconia blanks), which is a material used for dental restorations, not a diagnostic or AI-assisted device that would involve human readers interpreting images.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• No, a standalone performance study was not done.
• This device is a material, not an algorithm or AI system.

7. Type of Ground Truth Used

• The ground truth for the device's performance was established through measurement against established scientific and regulatory standards for material properties.
  • For physical and chemical properties (flexural strength, chemical solubility, uranium 238 activity concentration), the "ground truth" was the required value specified in the DIN EN ISO 6872:2015 standard.
  • For uniformity, freedom from extraneous materials, and information provided, the "ground truth" was adherence to the standard's qualitative requirements, confirmed by visual inspection or documentation review.
• The study also relied on biocompatibility testing against EN ISO 10993-1 and EN ISO 10993-5, where the "ground truth" was compliance with biological safety requirements.

8. Sample Size for the Training Set

• This information is not applicable as the device is a dental material, not a machine learning or AI device that requires a training set.

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

• This information is not applicable as the device is a dental material, not a machine learning or AI device that requires a training set.

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