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ESTENIA C&B is indicated for the following applications for the restoring crowns and defects.

1. Facing cast crowns and facing cast bridges
2. Jacket crowns
3. Inlays and onlays
4. Bridges with frameworks

This device is a polymer based material, used for fabricating prosthetic appliance such as facing cast crowns, facing cast bridges, jacket crowns, inlays, onlays or bridges with frameworks, and for repair of those prosthetic appliances made of resin based crown and bridge materials or porcelain.

The provided text does not contain detailed information about acceptance criteria or a specific study proving the device meets them in the way typically found for an AI/ML medical device. This document is a 510(k) summary for a dental material (ESTENIA C&B), which relies on substantial equivalence to predicate devices rather than a performance study against specific acceptance criteria for AI algorithms.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device. This document describes a dental material and its physical/mechanical properties, not an AI algorithm's performance against clinical endpoints.

The document states:

• "The physical and mechanical properties of ESTENIA C&B are verified by evaluation test based on ISO 10477."

This suggests that compliance with ISO 10477 serves as the "acceptance criteria" for the physical and mechanical properties of the material. However, no specific numerical values or ranges are provided for these properties, nor are the reported results from the evaluation test detailed.

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

Not applicable for an AI/ML device. This document refers to the evaluation of a dental material. The "test set" would likely refer to samples of the material tested in a lab for physical and mechanical properties. No details on the sample size or data provenance (e.g., country of origin, retrospective/prospective) for these material tests are provided.

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

Not applicable. The ground truth for a dental material's physical and mechanical properties is typically established by standardized laboratory testing methods, not by expert consensus in a clinical setting.

4. Adjudication Method

Not applicable. Adjudication methods (e.g., 2+1, 3+1) are for resolving discrepancies in expert interpretations of clinical data, which is not the context here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

Not applicable. MRMC studies are specific to evaluating AI's impact on human reader performance, which doesn't apply to a dental material.

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

Not applicable. This is not an AI algorithm. The performance described relates to the intrinsic physical and mechanical properties of the dental material.

7. The Type of Ground Truth Used

The ground truth for the device's properties is based on standardized laboratory testing methods, specifically those outlined in ISO 10477. In this context, "ground truth" refers to the objectively measured physical and mechanical properties of the material according to established international standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no concept of a "training set" in the machine learning sense. The material itself is "trained" through its manufacturing process to achieve certain properties.

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

Not applicable. As noted above, this isn't an AI/ML device. The "ground truth" for the material's properties is established through the ISO 10477 evaluation tests during development and quality control of the manufacturing process.

In summary, the provided 510(k) summary for ESTENIA C&B pertains to a dental material and relies on demonstrating substantial equivalence to predicate devices, primarily through chemical composition and physical/mechanical properties verified against an international standard (ISO 10477). It does not contain the type of AI/ML device performance study details requested.

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ESTENIA is used for the following cases:

• 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, inlay and onlay restorations.

The provided document is a 510(k) summary for a dental material called ESTENIA. It states that the submission aims to alter the manufacturer's name and address, and not to intend other changes to the device itself. Therefore, the device's technological characteristics, chemical ingredients, and safety are completely the same as the predicate device (K982164).

This means the submission does not contain a new study demonstrating that the device meets acceptance criteria because it is essentially a rebranding/transfer of ownership of an already approved device. The "acceptance criteria" and "study" would have been part of the previous 510(k) submission (K982164) for the original ESTENIA device by Kuraray Co., Ltd.

Based on the provided document, the following information cannot be extracted because no new study was conducted for this specific 510(k) submission:

1. A table of acceptance criteria and the reported device performance: Not provided. The document explicitly states the device is identical to the predicate.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
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: Not applicable. This device is a dental material, not an AI or imaging device with human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a dental material.
7. The type of ground truth used: Not provided.
8. The sample size for the training set: Not applicable. This device is a dental material, not a machine learning algorithm.
9. How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission relies on the substantial equivalence principle, asserting that the device (ESTENIA by Kuraray Medical Inc.) is identical to its predicate device (ESTENIA by Kuraray Co., Ltd., K982164). Therefore, no new efficacy or performance studies are presented in this document.

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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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