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It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration.

Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors. The product is mainly composed of purified water(55%95%), ferric chloride (09%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%1%) and Yttrium chloride(012%).

The document describes the Pre-Sintered Zirconia Coloring Liquid and its non-clinical testing for safety and performance.

Here's an analysis of the provided information regarding acceptance criteria and the study:

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

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

The document does not specify the exact sample size used for each physical and biocompatibility test. It mentions "dental specimens" for the post-dyeing comparison and implies testing on samples for heavy metal content, cytotoxicity, hypersensitivity, intradermal reaction, and systemic toxicity. The provenance of the data is not explicitly stated beyond being "non-clinical testing" conducted on the subject device. It is assumed to be internal testing by Chengdu Besmile Medical Technology Co., Ltd.

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

The document does not mention the involvement of experts for establishing ground truth in the non-clinical tests described. The "ground truth" for these tests would be defined by the standardized methodologies (e.g., ISO standards for biocompatibility, instrumental measurements for heavy metals, visual comparison against color guides for post-dyeing).

4. Adjudication method for the test set

Not applicable for these types of non-clinical tests. The tests rely on objective measurements and adherence to specified standards rather than expert adjudication.

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 a pre-sintered zirconia coloring liquid, not an AI-powered diagnostic device, so MRMC studies are not relevant.

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

Not applicable. This is a material product, not a software algorithm.

7. The type of ground truth used

• Physical Testing: Ground truth is established by:
  • Specification: Product technical requirements.
  • Appearance: Visual inspection against established criteria (homogeneous and impurity-free).
  • Post-dyeing comparison: Comparison against VITA veneer colorimeter or standard dental specimens.
  • Heavy metal content: Analytical measurement against a specified threshold (less than 10 mg/L in Pb).
• Biocompatibility Testing: Ground truth is established by adherence to the criteria defined in the specific ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11) for non-cytotoxicity, non-hypersensitivity, non-intradermal reaction, and non-systemic toxicity.

8. The sample size for the training set

Not applicable. This device is a material product, not an AI model that requires a training set.

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

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

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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.

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BruxZir® Incisal Coloring Liquid is intended to be used by trained dental technicians as an accessory for shading BruxZir® Shaded 16 PLUS and BruxZir® Esthetic all zirconia, monolithic restorations for anterior and posterior dental prosthetics.

BruxZir™ Incisal 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. BruxZit™ Incisal Coloring Liquid is available in 3 different colors, Premium, Premium HT, and Pearl. The devices are used on incisal areas of dental restoration to mimic natural tooth color. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.

The "BruxZir™ Incisal Coloring Liquid" is an accessory for shading zirconia dental restorations. The acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document doesn't explicitly state the sample sizes for each specific test (e.g., number of restorations tested for flexural strength, number of specimens for chemical solubility). It also doesn't specify the country of origin for the data or whether the studies were retrospective or prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

For the "Visual Shade Evaluation," the document states "qualified reviewers" performed the evaluation. However, it does not specify the number of reviewers, their professional qualifications (e.g., dental technicians with X years of experience, ceramists), or how "qualified" is defined.

4. Adjudication Method for the Test Set:

For the "Visual Shade Evaluation," it simply states the evaluation was done "against the reference shade guides." No specific adjudication method (e.g., 2+1, 3+1) is described for resolving discrepancies, implying a single reviewer's assessment or a consensus without a formal adjudication process. For other tests, the outcomes are quantitative measurements against established standards, so an adjudication method is not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The submission is focused on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.

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

This device is not an AI/algorithm-based device, so the concept of "standalone performance" in that context is not applicable. The device is a coloring liquid used in the fabrication process of dental prosthetics.

7. The Type of Ground Truth Used:

• Mechanical Properties (Flexural Strength, Chemical Solubility): The ground truth is defined by established international standards (ISO 6872:2015/Amd 1:2018), which specify minimum acceptable performance values.
• Biocompatibility: Ground truth is established by international standard (ISO 10993-1, ISO 10993-5:2009) requirements.
• Visual Shade Evaluation: Ground truth is established by "reference shade guides" and evaluation by "qualified reviewers."
• Shelf Life: Ground truth is based on the methodology outlined in ASTM F1980-21.
• Packaging Validation: Ground truth is based on established testing protocols to ensure packaging integrity.

8. The Sample Size for the Training Set:

This device is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense.

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

As there is no training set, this question is not applicable.

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

BruxZir™ Opaque 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™ Opaque Coloring Liquid is available in different colors, Opaq-Lite, Opaq-A, Opaq-C, Opaq, Opaq Plus. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.

This document describes the premarket notification (510(k)) for the BruxZir™ Opaque Coloring Liquid, a dental device. The information provided outlines the device's technical characteristics and the performance data submitted to demonstrate substantial equivalence to a predicate device.

Key takeaway: This submission focuses on the chemical and mechanical properties of the coloring liquid and its effect on zirconia, not on the performance of an AI-powered medical device. Therefore, many of the requested criteria regarding AI device studies (like sample size for data provenance, expert ground truth establishment, MRMC studies, etc.) are not applicable to this document.

However, I can extract the relevant acceptance criteria and performance data for this specific type of dental product:

Acceptance Criteria and Reported Device Performance

None of the provided sections deal with general medical device acceptance criteria. However, specific performance tests and their conclusions are mentioned in the "PERFORMANCE DATA" section (VII). These can be interpreted as the "acceptance criteria" met by the device.

Table of Acceptance Criteria and Reported Device Performance:

Further Requested Information (and why it's not applicable in this context):

Given that this is a 510(k) submission for a dental coloring liquid, not an AI-powered diagnostic or therapeutic device, most of the remaining questions are not directly addressed in the provided document, as they pertain to clinical studies, AI algorithms, and human-in-the-loop performance evaluation.

2. Sample size used for the test set and the data provenance: Not applicable. Tests involve material properties and physical assessments, not clinical data sets in the typical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: For "Visual Shade Evaluation," "qualified reviewers" are mentioned, but the number and specific qualifications are not detailed. For material property tests, ground truth is established by standardized testing methods (e.g., ISO, ASTM).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for material and physical property testing. Visual shade evaluation would likely have involved a consensus or multiple assessments, but details are not provided.
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 a dental coloring liquid, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth was established by adherence to recognized international standards (ISO, ASTM) for physical and chemical properties, and subjective "shade match requirements" for visual evaluation.
8. The sample size for the training set: Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In conclusion, the document provides evidence of the device's compliance with established material and performance standards relevant to dental coloring liquids, ensuring its substantial equivalence to a predicate device. It does not involve AI or the associated clinical study methodologies.

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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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DMAX coloring liquid, Chang's liquid, Confident coloring liquid, and CAMeleon coloring liquid can be used as an accessory to zirconium dioxide dental restorative material to provide individual tooth (or teeth) shading. It is intended to be used solely by certified dental technicians for fabrication of zirconium dioxide restorations for individual dental patients.

The subject device is water-based solution. It is used for the individual staining of dental zirconia frameworks and restorations prior to the final sintering. It enables trained dental technicians to adjust the restoration to match the natural color of the patient's teeth. The liquid has 45 shades are available in 15ml, 20ml, 30ml, 40ml and 100ml volumes. We offer the product in four different names: DMAX Coloring Liquid, Chang's Liquid, Confident Coloring Liquid, CAMeleon Coloring Liquid. They are just different names for the same products.

This document describes the premarket notification for DMAX Coloring Liquid and related products. It is not an AI/ML medical device, but rather a dental accessory used for shading zirconia dental restorations. Therefore, the information requested about acceptance criteria and study design from an AI/ML perspective is not applicable here.

However, I can provide the available information regarding the device's performance testing and comparison to a predicate device.

Performance Data (Non-Clinical) - Not AI/ML Specific

The performance data provided is for a dental coloring liquid, not an AI/ML device. The "acceptance criteria" in this context are implicitly met if the test results support substantial equivalence to the predicate device and comply with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device, there are no "acceptance criteria" in the typical sense of metrics like sensitivity, specificity, or AUC. Instead, the device's performance is demonstrated through non-clinical bench testing to ensure safety and functionality, and its substantial equivalence to a predicate device is established by comparing characteristics.

2. Sample Size for Test Set and Data Provenance

This information is not provided in the document. The tests performed are non-clinical bench tests (e.g., in vitro biocompatibility, chemical analysis), not tests involving patient data or clinical samples in the way an AI/ML device would be evaluated.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The "ground truth" here relates to the chemical and physical properties of the coloring liquid and its biocompatibility, which are determined by established scientific methods and laboratory testing, not by expert interpretation of images or patient data.

4. Adjudication Method

Not applicable. This is not a study involving human readers or interpretations needing adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a non-AI/ML dental accessory.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a non-AI/ML dental accessory.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is derived from:

• Bench Test Results: Objective measurements from laboratory tests for physicochemical properties (pH, boiling point, density, solubility) and biocompatibility (cytotoxicity, sensitization, irritation, oral mucosa irritation) according to referenced standards (e.g., ISO 10993).
• Predicate Device Characteristics: Comparison to an already cleared device's known characteristics and performance to establish substantial equivalence.

8. Sample Size for Training Set

Not applicable. This device does not involve a training set as it is not an AI/ML algorithm.

9. How Ground Truth for Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary of Device and Performance Evaluation:

The DMAX Coloring Liquid family of products are water-based solutions with inorganic pigments used to shade zirconia dental restorations. Their premarket notification to the FDA focuses on demonstrating substantial equivalence to an existing predicate device (LUMINESSE® PRE-SINTERED ZIRCONIA COLORING LIQUID). This is achieved through:

• Comparison of Device Characteristics: Showing similar indications for use, principle of operation, technology (water-based with inorganic pigments), prescription use, target population, general physical form, and sterility to the predicate.
• Bench Testing: Non-clinical tests were conducted according to relevant standards (e.g., ISO 10993 for biocompatibility) for properties such as shelf life, cytotoxicity, sensitization, irritation, oral mucosa irritation, appearance, volume, packaging, uniformity, and chemical solubility. The document states that "All the test results support substantial equivalence to the predicate devices."
• Physicochemical Property Comparison: Specific values for pH, boiling point, density, specific gravity, and water solubility were provided for both the subject device and the predicate device, indicating comparable profiles.

The differences noted (packaging volume, number of shades, shelf life/storage conditions) were deemed not to raise new questions of safety or effectiveness, particularly because the shelf life test results supported equivalence despite different storage duration/conditions.

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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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Tanaka ZirColor™ Coloring Liquid and Tanaka ZirColor™ Dipping Liquid are liguids for the shading of white zirconia ceramic materials. This product is intended to be used by professional dental technicians for fabrication of all-ceramic single tooth crown and bridgework restorations.

Tanaka Enamel ZR™ Blocks are yttria-stabilized tetragonal zirconia polycrystals (Y-TZP) ceramic (zirconia) blanks intended to be used by professional dental technicians for the fabrication of all-ceramic restorations. It is recommended for manufacturing single-tooth and bridgework restorations, like crowns and bridges with one or two pontics, which can be used in the anterior as well as in the posterior tooth region.

Tanaka ZirColor™ Coloring Liquid is supplied as twenty different shades (4 ml each) of metallic oxide based liguid used for the shading of white zirconia ceramic materials. The liquid is identified as the following twenty shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, Occlusal, C1, C2, C3, C4, D2, D3, D4 Incisal Dk, Incisal Lt and Pink. A liquid thinner agent comprised solely of the base component contained in the Tanaka ZirColor™ Coloring Liquid (15 ml), and 2 birch wood handle brushes for the application of the coloring agent also are supplied.

Tanaka ZirColor™ Dipping Liquid (50% diluted formulation of the Tanaka ZirColor™ Coloring Liquid) is supplied as sixteen different shades (30 ml each) of metallic oxide based liquid used for the shading of white zirconia ceramic materials. The Tanaka ZirColor™ Dipping Liquid is identified as the following sixteen shades: A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, and D4.

Tanaka Enamel ZR™ Blocks are yttria-stabilized zirconium dioxide (Y -TZP) ceramic (zirconia) blanks supplied in the following five shades: neutral, light, medium, dark and body. These shades are achieved by using the different shades of ZirColor™ Liquid noted above. The zirconia blanks are provided as the following ten sizes:
No. 01 98.25 +/- 0.2 mm 10.0+/- 0.1 mm
No. 02 98.25 +/- 0.2 mm 12.0+/- 0.1 mm
No. 03 98.25 +/- 0.2 mm 14.0+/- 0.1 mm
No. 04 98.25 +/- 0.2 mm 16.0+/- 0.1 mm
No. 05 98.25 +/- 0.2 mm 18.0+/- 0.1 mm
No. 06 98.25 +/- 0.2 mm 20.0+/- 0.1 mm
No. 07 98.25 +/- 0.2 mm 22.0+/- 0.1 mm
No. 08 98.25 +/- 0.2 mm 24.0+/- 0.1 mm
No. 09 98.25 +/- 0.2 mm 26.0+/- 0.1 mm
No. 10 98.25 +/- 0.2 mm 29.0+/- 0.1 mm

The provided documentation (K140491) does not describe an AI medical device or a study proving its performance against acceptance criteria in the context of AI. Instead, it is a 510(k) premarket notification for dental products: "Tanaka ZirColor™ Coloring Liquid, Tanaka ZirColor™ Dipping Liquid and Tanaka Enamel ZR™ Blocks."

This document focuses on establishing substantial equivalence to previously cleared predicate devices (ZENO Zr Disc, Zenotec Color Zr, Zenostar Color Zr, Zenotec Zr Bridge, and Zenostar Zr Translucent cleared under K112710) based on intended use, technology, and performance, primarily through material composition and physicochemical testing, not AI performance metrics.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment for an AI device. The document simply does not contain this type of information.

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

Upcera Coloring Liquid (I and II) 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. Upcera Coloring Liquid I is provided in 21 different shades, and Upcera Coloring Liquid II is provided in 16 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 text describes a 510(k) premarket notification for a medical device called "Upcera Coloring Liquid (I and II)". It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered medical device.

The document is a submission to the FDA for a coloring liquid for dental zirconia, which is a material used in dental restorations. The "performance testing" described in Section 5.9 and Table 5.2 refers to biocompatibility testing of the coloring liquid itself, which is a standard requirement for materials that will be in contact with the human body, not a performance study of an AI device.

Therefore, I cannot provide the requested information about acceptance criteria and a study as the device described is not an AI/ML powered medical device.

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