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BruxZir™ TintEFX Coloring Liquid is used for coloring pre-sintered zirconia structures.

BruxZirTM TintEFX Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, 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°C.

BruxZir™ TintEFX Coloring Liquid is available in 14 different colors, Brown, Green, Blue, Pink, Orange, Purple, Grey, Yellow, G00, G0, G1, G3, G4, and G5. The devices can be used on the gingival part, body part, and/or incisal part of dental restoration to provide esthetic properties and mimic nature tooth color. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.

This document describes the FDA's 510(k) clearance for BruxZir™ TintEFX Coloring Liquid, a dental product. It primarily focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against specific acceptance criteria for an AI/CADe medical device study. Therefore, most of the information requested in your prompt (e.g., sample size for test set, number of experts, MRMC studies, training set details) is not applicable to this type of submission.

This document is for a "Porcelain Powder For Clinical Use" (though the device itself is a liquid for coloring zirconia) which falls under a general controls classification. The "performance data" presented are non-clinical tests to show the new device performs similarly to the predicate and meets general dental material standards.

However, I can extract the information that is present and explain why other aspects are not applicable.

Explanation of Non-Applicability:

The requested information (e.g., sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, ground truth establishment for training) is highly relevant for the assessment of AI/CADe (Computer-Assisted Detection/Diagnosis) medical devices or other diagnostic/interpretive devices where the primary function is to analyze data (like medical images) and provide an output that impacts a clinical decision.

This document describes a coloring liquid used in the fabrication of dental restorations. Its performance is evaluated based on material properties (flexural strength, chemical solubility, visual shade) and biocompatibility, not on its ability to "diagnose" or "detect" anything using an algorithm. Therefore, the concepts of "test set," "training set," "ground truth experts," or "AI assistance" do not apply.

Here's the breakdown of the available information, addressing your points where applicable:

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

The document doesn't explicitly state "acceptance criteria" in the format of a diagnostic performance study (e.g., sensitivity, specificity thresholds). Instead, it refers to industry standards and general material requirements. The "performance" is reported as meeting these standards.

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

• Sample Size: Not specified in terms of a "test set" for diagnostic performance. For material testing, typical sample sizes are implied by the ISO standards (e.g., a certain number of specimens for flexural strength), but exact numbers are not provided in this summary.
• Data Provenance: Not applicable. This is a non-clinical evaluation of a material, not a study involving patient data.

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

• Not applicable. There is no "ground truth" establishment by experts in the sense of reviewing clinical cases or images. For "Visual Shade Evaluation," it states "performed on the sintered and glazed restorations by qualified reviewers against reference shade guides." The number and specific qualifications of these "qualified reviewers" are not detailed, as this is a quality control/aesthetic assessment, not a clinical diagnostic assessment.

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

• Not applicable. This relates to obtaining a consensus truth for diagnostic studies, which is not relevant here.

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 type of study evaluates human reader performance with and without AI, which is not relevant for a dental coloring liquid.

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

• Not applicable. There is no algorithm being evaluated.

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

• Not applicable in the conventional sense. The "ground truth" for this device's performance is adherence to established material standards (like ISO 6872:2015) for physical properties and subjective assessment against shade guides for visual properties. Biocompatibility relies on adherence to ISO 10993 standards and testing results.

8. The sample size for the training set

• Not applicable. No AI algorithm requiring a training set is involved.

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

• Not applicable. No AI algorithm requiring a training set is involved.

In summary, this FDA clearance document for BruxZir™ TintEFX Coloring Liquid pertains to a dental material, not an AI or diagnostic device. As such, the typical acceptance criteria and study methodologies relevant to AI/CADe are not found or applicable in this submission. The "study" mentioned here refers to non-clinical laboratory testing to prove the material meets relevant standards and is substantially equivalent to a predicate device.

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