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Luminesse Pre-Sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse ZR blanks to provide individualized tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of all ceramic restorations for individual dental patients.

Luminesse® Pre-sintered Zirconia Coloring Liquid is a device that can be used as an accessory to zirconium dioxide dental restorative material such as Luminesse® ZR blanks to provide individualized tooth (or teeth) shading. It is a liquid ceramic aid for complete or partial coloring of all zirconium oxide blanks. Dental restorations are designed and manufactured by a certified dental professional (Technician) using CAD/CAM technology.

The provided document is a 510(k) Pre-Market Notification for a medical device called "Luminesse® Pre-Sintered Zirconia Coloring Liquid." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through clinical trials with specific acceptance criteria as you might see for a novel, high-risk device.

Therefore, the document does not contain a study that proves the device meets specific acceptance criteria in the traditional sense of a clinical or performance study for an AI/software device. Instead, it demonstrates substantial equivalence based on a comparison of technological characteristics and performance data that the new device shares with a predicate device.

Here's a breakdown of the requested information based on the provided document, highlighting where the information is not applicable due to the nature of a 510(k) substantial equivalence submission for this type of device:

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

Since this is a 510(k) for a coloring liquid, the "acceptance criteria" are not framed as performance metrics for an AI or diagnostic device, but rather as characteristics of the material that show it is similar to the predicate. The performance data presented refers to standard physical and chemical properties.

Conclusion from Document: The document concludes that "the differences…do not raise new questions of safety and effectiveness." The data supplied for both new and predicate device on physical and mechanical properties demonstrate similarity, "albeit unequal results," and are "within the expected specifications for zirconia dying liquid materials for dental application."

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

• Not Applicable (N/A): This is a 510(k) submission for a coloring liquid, not a diagnostic or AI device that typically involves test sets of patient data. The "test set" here refers to the samples of the coloring liquid itself that were tested for physical and chemical properties. There is no mention of the specific number of liquid samples tested, nor is there information about data provenance in terms of country of origin or retrospective/prospective studies. The performance data is based on material property testing.

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 (N/A): Ground truth established by experts is relevant for diagnostic or AI systems where human interpretation is the gold standard. For a coloring liquid, the "ground truth" is determined by objective physical and chemical measurements (e.g., pH, density, boiling point), which are standard laboratory procedures, not expert consensus on qualitative data.

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

• Not Applicable (N/A): Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in expert interpretation, typically in studies involving human readers or AI. This is not relevant for the objective physical and chemical testing of a dental coloring liquid.

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 (N/A): MRMC studies are used to evaluate the performance of diagnostic tools (often AI-assisted) by comparing multiple readers on multiple cases. This device is a coloring liquid, not a diagnostic or AI tool, so an MRMC study is not relevant.

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

• Not Applicable (N/A): This concept applies to standalone AI algorithms. The Luminesse® Pre-Sintered Zirconia Coloring Liquid is a physical material, not an algorithm. Its performance is inherent to its physical and chemical properties.

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

• Laboratory Measurements / Physical and Chemical Standards: The "ground truth" or reference for the device's characteristics are standardized measurements of physical properties (e.g., general physical form, specific physical form, odor, color, boiling point, density, specific gravity, solubility) and chemical properties (e.g., pH). These are determined in a laboratory setting using established analytical methods, not through expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

• Not Applicable (N/A): This device is a material, not a machine learning model. Therefore, there is no "training set" in the context of AI or data-driven model development.

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

• Not Applicable (N/A): Since there is no training set as described above, this question is not applicable.

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