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Zirkonzahn COLOUR LIQUID is used for coloring pre-sintered zirconia structures.

Zirkonzahn COLOUR LIQUID devices are used for coloring milled and finished presintered zirconia structures. Coloring is performed by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400 ℃.

The Zirkonzahn COLOUR LIQUIDS are available in different colors and in different bottle sizes (20 ml, 50 ml, 100 ml).

This document is a 510(k) Pre-market Notification for a dental device (Color Liquid, Vita Liquid). It establishes substantial equivalence to a predicate device, meaning it does not require a complex efficacy study with acceptance criteria and a human-in-the-loop study as would be required for an AI/ML device or a novel high-risk device.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical tests demonstrating that the coloring liquid does not negatively impact the functionality or biocompatibility of the zirconia structures it's applied to, and that the product is stable over its stated shelf life.

Here's a breakdown of the available information in relation to your request, highlighting what is provided and what is not applicable to this type of submission:

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

The document mentions non-clinical tests to evaluate physical properties, shelf life, and biocompatibility. However, it does not provide specific acceptance criteria or quantitative results in a table format. It generally states that "The results show that the devices are well suited for their intended use."

The relevant sections are:

• Section 05, "DISCUSSION OF NON CLINICAL TESTS" (page 5):
  • "Non-clinical testing was performed to evaluate the physical properties of colored zirconia compared to untreated zirconia, to demonstrate that the subject device does not negatively impact the functionality of the zirconia. The results show that the devices are well suited for their intended use."
  • "Furthermore, to establish the shelf life and storage conditions of the subject devices, real time aging was performed (including evaluation of color, workability and appearance) according to Zirkonzahn internal test protocols."
  • "Biocompatibility was established in consideration of the International Standard 10993-1:2010 'Biological Evaluation of Medical Devices' Part 1: Evaluation and Testing."

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

• Sample Size: Not specified for any of the non-clinical tests (physical properties, aging, biocompatibility).
• Data Provenance: The tests were performed by Zirkonzahn ("Zirkonzahn internal test protocols" and "Zirkonzahn performed biocompatibility testing"). The country of origin for the data is implicitly Italy, where Zirkonzahn srl is located. These are laboratory tests, not clinical data from patients (retrospective/prospective).

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

• Not applicable in the context of this device. The "ground truth" for the non-clinical tests would be defined by standardized test methods or internal protocols (e.g., measuring physical properties according to a standard, chemical analysis for biocompatibility). There are no human "experts" establishing clinical ground truth for image interpretation or diagnosis, as this is not an AI/ML diagnostic device.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, especially those involving expert reads of medical images, to resolve discrepancies and establish a consensus ground truth. This document describes laboratory testing for a dental material.

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 is not an AI/ML device or a device requiring a clinical effectiveness study with human readers. It's a coloring liquid for dental zirconia.

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

• Not applicable. This is not an algorithm or software.

7. The type of ground truth used:

• The "ground truth" for the non-clinical tests would be based on:
  • Physical Property Measurements: Objective measurements against predefined specifications or baseline (untreated zirconia).
  • Real-time Aging: Evaluation of objective characteristics like color, workability, and appearance over time, compared to initial properties and established shelf-life criteria.
  • Biocompatibility: Results against established criteria from ISO 10993-1:2010 (e.g., cytotoxicity, sensitization, irritation tests for representative and worst-case mixtures). This is typically based on laboratory assay results.

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML device that requires training data.

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

• Not applicable, as there is no training set for this device.

In summary, this 510(k) submission for a dental coloring liquid focuses on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical testing of material properties, shelf-life, and biocompatibility, rather than clinical efficacy studies or AI/ML performance evaluation. Therefore, many of the requested details related to clinical trials, AI/ML performance metrics, and expert-based ground truth are not relevant or provided in this type of regulatory document.

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