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Color characterization for:

• 1. Jacket crown
• Facing crown 2)
• 3. Inlay and onlay

CHROMA ZONE COLOR STAIN is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.
CHROMA ZONE COLOR STAIN consists of 11 Stain Pastes, the Clear Paste and accessories. These components are similar to that of stain materials of the products in the paragraph 4 of this summary.
In general, resin-based crown and bridge materials consists of body resin such as transparent, enamel and dentin, opaque resin, stain and accessories. CHROMA ZONE COLOR STAIN is a stain material for color characterization to be used in conjunction with resin-based crown and bridge materials.

This document is a 510(k) premarket notification for the "CHROMA ZONE COLOR STAIN" device. It does not contain information about acceptance criteria for device performance or a study demonstrating the device meets such criteria through metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and safety. The safety is primarily assessed through biological evaluation (acute toxicity and genotoxicity tests) of key components.

Here's an breakdown of the information presented:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not contain specific acceptance criteria for performance metrics (e.g., color accuracy, color stability over time, wear resistance) typically associated with a "performance study" in the context of device efficacy.

The "performance" described is largely about the chemical stability and biological safety of its components, and its equivalence to predicate devices in function and intended use.

The biological evaluation section provides the following performance data:

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

• Acute Toxicity (BGP): Animal: Mouse. Specific sample size (number of mice) is not provided.
• Acute Toxicity (DTA): Animal: Rat. Specific sample size (number of rats) is not provided.
• Genotoxicity Test (DTA): Method: Ames test. This is an in vitro bacterial test; a "sample size" in the conventional sense of human or animal subjects is not applicable here.

The data provenance is from laboratory testing (in vivo animal studies for toxicity and in vitro bacterial tests for genotoxicity). The country of origin for these specific tests is not explicitly stated, but the submitter is a Japanese company (Kuraray Co., Ltd.). This is prospective testing conducted to support the device's safety.

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

• This information is not applicable to the data presented. The "ground truth" for toxicity and genotoxicity tests is established by standardized laboratory protocols and scientific interpretation of results, not by expert consensus in the same way clinical diagnostic studies use experts.

4. Adjudication Method for the Test Set:

• This is not applicable as the document describes laboratory safety testing, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• No, an MRMC comparative effectiveness study was not done. This document describes a dental material (a color stain for dental restorations), not an AI-powered diagnostic device. Therefore, the concept of "human readers improve with AI" is not relevant here.

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

• No, a standalone performance study was not done. Again, this is a material device, not an algorithm.

7. The Type of Ground Truth Used:

• For the biological evaluation, the "ground truth" is based on standardized toxicological endpoints (LD50 values for acute toxicity, and negative/positive results for genotoxicity) as determined by established laboratory testing methods. There is no external "ground truth" like pathology or outcomes data in the context of a clinical study for these tests.

8. The Sample Size for the Training Set:

• This is not applicable. This device is a material, not a machine learning model, so there is no "training set."

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

• This is not applicable for the same reason as above.

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This device is used for the following indications. Each indication is same to that of similar products.

1. Jacket crown
2. Facing crown
3. Inlay and onlay

ESTENIA is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers › intended to be used for laboratory fabrication of jacket crown, facing crown, inlay and onlay restorations.
ESTENIA consists of Body Resin, Opaque Resin, Opaque Primer, Modeling Liquid, Add-on Primer, Air-Barrier Paste and accessories.

The provided text describes the ESTENIA dental material and its performance characteristics but does not include a study that proves the device meets specific acceptance criteria in the context of an AI/ML medical device. This document is a 510(k) premarket notification for a dental material, not an AI/ML device. Therefore, many of the questions regarding AI/ML study design (like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable.

However, I can extract the acceptance criteria (in terms of physical properties and biocompatibility) and the reported performance from the document.

Acceptance Criteria and Reported Device Performance (Physical Properties)

The document refers to ISO 10477:1992 as a relevant standard, but states ESTENIA "is not applicable to ESTENIA because of following reasons" (special activation system, intended use in stress-bearing areas). Despite this, it evaluates properties with "modified test methods" to fulfill "the requirements of ISO 10477 excluding the test methods." Therefore, the requirements of ISO 10477 for these physical properties can be considered the acceptance criteria, and the reported values are the device performance.

Acceptance Criteria and Reported Device Performance (Biocompatibility)

The biocompatibility tests evaluate the safety of the individual components and the cured resin. The acceptance criterion for these tests is generally a "Negative" result, indicating no adverse biological effects.

Non-Applicable or Not Provided Information (for AI/ML context):

1. Sample size used for the test set and the data provenance: Not applicable. This is not an AI/ML study using a test set of data. The physical property tests involve prepared specimens, and biocompatibility tests use animal models or bacterial cultures.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical properties comes from direct measurement, and for biocompatibility from established biological endpoints.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 diagnostic or assistive device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physical properties, the "ground truth" is the measured value against a standard specification (ISO 10477). For biocompatibility, it's the observed biological response against accepted safety thresholds (e.g., LD50, negative Ames test, no irritation/sensitization).
7. The sample size for the training set: Not applicable. This is not an AI/ML device.
8. How the ground truth for the training set was established: Not applicable.

Additional Study Information (Mechanical Strength Comparison):

The document also provides a comparative study of mechanical strength with predicate devices:

• Study Design: House test methods for compressive strength and flexural strength.
• Performance Comparison:
  • Compressive strength (MPa): ESTENIA (620) vs. CONQUEST (473) vs. ARTGLASS (340)
  • Flexural strength1 (MPa): ESTENIA (202) vs. CONQUEST (160) vs. ARTGLASS (121)
• Conclusion: The mechanical strengths of ESTENIA are stated to be "substantially equivalent to that of products sold in the U.S. market," and in the presented data, ESTENIA shows higher compressive and flexural strength than the compared predicate devices.

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