Search Results

Cercon® yo ML is indicated in the anterior and posterior segments for:

• Crowns
• Multi-unit bridges (with a maximum of two pontics between abutment crowns)
• Inlays, onlays and veneers

The proposed Cercon® yo ML is a partially sintered ceramic blank composed of yttrium oxide-(yttria-) stabilized zirconium oxide (zirconia) (Y-TZP). Cercon® yo ML is a multilayer disk built out of different shade layers and yttrium oxide contents which create a natural gradient of the restoration after sintering. The proposed device is supplied to dental professionals as a blank and then processed by machining and subsequent sintering to fabricate dental ceramic restorations.

The provided text describes acceptance criteria and the study conducted for the Cercon® yo ML device, specifically focusing on non-clinical performance data.

Here's a breakdown of the requested information:

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)

The document does not explicitly state the sample sizes for the bench tests. It refers to general standards (ISO 6872, ISO 9693, ISO 10993 series) which typically define the number of samples required for each test. The data provenance is not mentioned, but these are non-clinical engineering and biological tests, not patient-specific data.

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 section is not applicable. The studies described are non-clinical bench tests and biocompatibility assessments, which rely on established scientific and engineering standards and laboratory measurements, not expert consensus for ground truth.

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

This section is not applicable. Adjudication methods are typically used in clinical studies involving interpretation of data by multiple experts. The described studies are non-clinical bench tests.

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

There is no mention of an MRMC study or AI assistance in the provided text. The device, Cercon® yo ML, is a partially sintered ceramic blank for dental restorations, not an AI-powered diagnostic or assistive device.

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

This section is not applicable. The device is a material for dental restorations, not a software algorithm.

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

For the non-clinical performance data:

• Material properties (Flexural Strength, CTE, Solubility, Radioactivity, Shrinkage factor, Uniformity, Freedom from extraneous materials): The ground truth is based on the specified physical, chemical, and mechanical properties as defined by the ISO 6872:2015 Amd 1. 2018 standard. The "ground truth" is the established limit or range defined by the standard.
• Compatibility (De-bonding / crack-initiation, Thermal shock resistance): The ground truth is based on the specified performance criteria defined by the ISO 9693:2019 standard.
• Biocompatibility: The ground truth is established by the requirements of the ISO 10993 series of standards and USP , which define acceptable biological responses and toxicity levels.

8. The sample size for the training set

This section is not applicable as the studies described are non-clinical bench tests and biocompatibility assessments, not machine learning model training.

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

This section is not applicable as there is no training set mentioned or implied for this type of device and testing.

Ask a specific question about this device