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CLEARFIL SE BOND PLUS is indicated for the following applications:

1. Direct restorations using light-cured composite resin or compomer
2. Cavity sealing as a pretreatment for indirect restorations
3. Treatment of hypersensitive and/or exposed root surfaces
4. Intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics or composite resin using light cured composite resin
5. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
6. Core build-ups using light- or dual-cured composite resin
7. Cavity sealing under amalgam restorations

CLEARFIL SE BOND PLUS is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. This device consists of the primer, the bond and the accessories, and is substantially equivalent in design to CLEARFIL SE BOND.

The provided text describes the submission of a 510(k) premarket notification for a dental adhesive system called "CLEARFIL SE BOND PLUS". The submission aims to establish substantial equivalence to predicate devices, rather than proving the device meets specific acceptance criteria in a study. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics for a diagnostic AI device is not available in this document.

However, I can extract information related to the device's properties and comparisons to predicate devices, which serve as a form of "acceptance criteria" in the context of a 510(k) submission for a non-AI device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "test set" in the context of an AI study. For the evaluated properties (biocompatibility, mechanical properties, physical properties), the specific sample sizes used for testing are not provided. The data provenance is described as being generated from various tests performed by Kuraray Medical Inc. and compared against their own and other manufacturers' predicate devices. The country of origin of the data would be Japan, where Kuraray Medical Inc. is based. The studies would be considered prospective for the "CLEARFIL SE BOND PLUS" device, as they were conducted to support its 510(k) submission.

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

This information is not applicable. The document describes laboratory-based testing of material properties, not an evaluation requiring expert consensus on a test set to establish ground truth in an AI/diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable. There was no adjudication method described as it pertains to expert reviews of a test set, which is common in AI studies.

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

No. This is a submission for a dental adhesive system, not an AI or diagnostic device that would involve human readers or MRMC studies.

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

No. This document does not describe an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the established scientific standards and methods for evaluating biomaterial properties (e.g., ISO standards for biocompatibility), and comparative performance against legally marketed predicate devices. For bond strength and physical properties, the "ground truth" is derived from quantitative measurements obtained through standardized laboratory tests.

8. The Sample Size for the Training Set

This information is not applicable, as this is not an AI/machine learning device. The term "training set" is not relevant here.

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

This information is not applicable, as this is not an AI/machine learning device.

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PANAVIA F is indicated for the following applications:
Cementation of metal crowns and bridges, inlays and onlays.
Cementation of porcelain crowns, inlays and onlays.
Cementation of to composite resin crowns, inlays and onlays
Cementation of adhesion bridges and splints
Cementation of metal cores and prefabrication posts
Bonded amalgam restorations

PANAVIA F is classified into dental cement, CFR 21 Section 872.3275, because it is a device composed of materials such as dimethacrylate monomers and inorganic fillers intended to be used for cementation of dental devices such as crowns or bridges.
PANAVIA F is a resin based cement cured chemically and by visible light activation, and the improved device of PANAVIA 21. There are two major improvements; the curing method and introduction of the metal adhesion primer (ALLOY PRIMER, K974089).
This device consists of Paste (A and B pastes), ED Primer (Liquids A and B), ALLOY PRIMER, Oxyguard II, and accessories.

This is a 510(k) premarket notification for a dental adhesive device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, and AI/ML specific metrics is not available in the provided text.

The document discusses the substantial equivalence of the "PANAVIA F" dental cement to predicate devices already on the market. The "acceptance criteria" in this context refer to the regulatory requirements for showing the new device is as safe and effective as existing ones, rather than performance metrics for an AI algorithm.

Specifically:

1. A table of acceptance criteria and the reported device performance: Not applicable in the context of an AI/ML device. The document states "These modifications do not affect the safety and effectiveness" of PANAVIA F compared to PANAVIA 21. The "performance" is implicitly tied to its intended use for cementation of dental devices.

2. Sample size used for the test set and the data provenance: Not applicable. This refers to a medical device's components and intended use, not a test set for an algorithm.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and effectiveness of the predicate devices.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

The core argument for the device's acceptance is its "substantial equivalence" to legally marketed predicate devices, meaning it shares similar design, composition, function, and intended use, and that any modifications do not negatively impact its safety and effectiveness.

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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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