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Coloring Liquid is a liquid used for the complete or partial coloration of milled zirconia substructure and anatomy before sintering.

Coloring Liquid is water based, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. Coloring Liquid is provided in 45 different shades, which are corresponding to patient's closest tooth color. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperatures

The provided documentation is a 510(k) summary for a medical device called "Coloring Liquid." It focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance acceptance criteria through a clinical study involving human subjects or complex algorithms.

Therefore, many of the requested sections (2, 3, 4, 5, 6, 7, 8, 9) regarding sample sizes, expert ground truth, adjudication methods, multi-reader studies, and training sets are not applicable to this type of submission. This document describes a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document reports and compares safety testing results, which can be interpreted as demonstrating that the device meets acceptance criteria for biocompatibility.

Study Proving Device Meets Acceptance Criteria:

The document states: "Bench testing was performed to ensure that the Coloring Liquid met its specifications. All tests were verified to meet acceptance criteria. Biocompatibility testing was performed to verify the equivalent safety of the materials that are used."

This indicates that internal bench tests and specific biocompatibility tests, following ISO 10993 standards, were conducted to demonstrate the safety of the device. The results of these biocompatibility tests are summarized in Table 5.2. The conclusion drawn is that the subject device's performance in these safety tests is comparable to the predicate device, thus meeting the implied safety acceptance criteria for this type of product.

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

• Not Applicable. This submission is for a material (coloring liquid) and focuses on biocompatibility and physicochemical properties, not a diagnostic or AI-powered imaging device that would require a "test set" of patient data in the typical sense. Biocompatibility tests are usually conducted on material samples in controlled laboratory settings (e.g., cell cultures, animal models as per ISO standards). The document does not specify the number of samples or specific animal models used, but refers to ISO standards.

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 device performance, typically refers to a definitive diagnosis or outcome for diagnostic/prognostic devices. For a coloring liquid, "ground truth" would relate to the chemical composition, color properties, and biocompatibility, which are verified through objective scientific methods and established ISO standards, not expert consensus in a clinical reading scenario.

4. Adjudication Method for the Test Set:

• Not Applicable. As there is no "test set" in the context of clinical interpretation, no adjudication method is relevant. Biocompatibility test results are typically interpreted by qualified laboratory personnel following established protocols.

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. The device is a "Coloring Liquid" for dental zirconia, not an AI-assisted diagnostic tool.

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

• Not Applicable. The device is a chemical product, not an algorithm.

7. The Type of Ground Truth Used:

• Objective Test Results / Standardized Biocompatibility Assays. For this device, the "ground truth" for proving safety and effectiveness (as understood in this context) comes from the results of standardized laboratory tests (e.g., cytotoxicity assays, irritation tests, sensitization tests, systemic toxicity tests, genotoxicity assays) conducted according to recognized international standards (ISO 10993 series). These tests provide objective data on the biological responses to the material.

8. The Sample Size for the Training Set:

• Not Applicable. This is not an AI/ML device that requires a training set.

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

• Not Applicable. This is not an AI/ML device that requires a training set.

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Coloring Liquid is a liquid used for the complete or partial coloration of zirconia ceramic materials.

Coloring liquid are water-based coloring liquids, which consist of watery, acidic metal salt solutions. They are used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering of the restoration, enabling the user to adjust the restoration to match the natural color of the patient's teeth. For staining, the zirconia materials have to be immerged into the liquids or to be brushed with the liquids, prior to sintering at high temperature.

The provided text is a 510(k) summary for a medical device called "Coloring Liquid." This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria in the format typically used for AI/ML-based diagnostic devices.

Therefore, many of the requested sections (acceptance criteria for a diagnostic device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, effect size, standalone performance, ground truth types) are not applicable or not provided in this regulatory submission.

The document primarily addresses the safety and effectiveness of the Coloring Liquid through comparison to a legally marketed predicate device and non-clinical bench testing.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available:

Device Name: Coloring Liquid

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

For this device, the "acceptance criteria" are primarily based on demonstrating similar properties and performance to the predicate device, particularly regarding safety (biocompatibility) and functional characteristics (coloration of zirconia). Specific quantitative performance metrics typical of diagnostic devices are not present.

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

• Sample size: Not specified. The document states "Bench testing was performed" and "Biocompatibility testing was performed," but does not detail the number of samples or specimens used for these tests.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). These are non-clinical (bench and biocompatibility) tests, not clinical data from patients.

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

Not applicable. This is not a diagnostic device involving expert interpretation of medical images or data. The "ground truth" for biocompatibility is established by standardized ISO testing protocols.

4. Adjudication method for the test set

Not applicable. There is no human adjudication process described for the non-clinical 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

Not applicable. This device is not an AI-assisted diagnostic tool.

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

Not applicable. This device is not an algorithm.

7. The type of ground truth used

For biocompatibility, the "ground truth" is defined by the results of standardized ISO 10993 series tests (e.g., cytotoxicity, irritation, sensitization, subchronic toxicity, genotoxicity). For functional aspects (coloration), the ground truth is implicitly based on achieving the intended aesthetic effect on zirconia, but specific quantitative metrics or expert evaluations of color matching are not detailed in this summary.

8. The sample size for the training set

Not applicable. This device is not an AI/ML system that requires a training set.

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

Not applicable.

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