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Indications for Use: Post cementation and core build-up

The subject device is a dual-cured (light-cured with self-curing property), radiopaque two-component core build-up material supplied in an automix delivery system which can mix equal amount of two components, and is available in two shades, Dentin and White.

This document describes a 510(k) premarket notification for a dental device, not an AI/ML medical device. Therefore, much of the requested information regarding AI/ML device studies, such as sample sizes for test/training sets, ground truth establishment by experts, adjudication methods, and MRMC studies, is not applicable or available within this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, chemical ingredients/safety, and physical/mechanical properties.

Here's an attempt to answer the questions based on the provided text, while acknowledging the limitations:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document states that physical and mechanical properties were evaluated according to ISO 4049: 2009, but it does not specify the sample size used for these evaluations or the data provenance.

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)

This is not applicable as this is a dental material device, not an AI/ML diagnostic device requiring expert interpretation for ground truth. The evaluation focused on compliance with a technical standard (ISO 4049).

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

This is not applicable for the same reason as above. There was no "test set" in the context of expert judgment for ground truth.

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

This is not applicable. This is a dental material device, not an AI/ML diagnostic or assistive device that would involve human readers.

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

This is not applicable. This is a physical dental material, not an algorithm.

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

The "ground truth" in this context refers to the requirements of the ISO 4049: 2009 standard for physical and mechanical properties of polymer-based restorative materials. The device's performance was compared against these predefined physical and mechanical thresholds.

8. The sample size for the training set

This information is not provided and is not applicable as this is not an AI/ML device requiring a training set.

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

This is not applicable as this is not an AI/ML device requiring a training set or its associated ground truth establishment.

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[1] Direct restorations using light cured composite resin

[2] Cavity sealing as a pretreatment for indirect restorations

[3] Treatment of exposed root surfaces

[4] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin

[5] Surface treatment of prosthetic restorations made of porcelain, ceramic or composite resin

[6] Surface treatment of dental posts

[7] Post cementation and core build ups using dual cured composite resin CLEARFIL DC CORE PLUS

[8] Core build ups using light cured composite resin

The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel.

The provided text describes the regulatory submission for a dental bonding agent, CLEARFIL TRI-S BOND PLUS, and references studies conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain explicit "acceptance criteria" in a quantitative tabular format or detailed "studies that prove the device meets acceptance criteria" with the specific information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, expert ground truth details, MRMC studies, standalone performance details).

Instead, the submission focuses on demonstrating substantial equivalence based on

1. Intended uses
2. Chemical ingredients/safety (biocompatibility)
3. Technological characteristics/effectiveness and performance.

The document indicates that for effectiveness and performance, "certain tests were performed on this device, in comparison with the predicate device and it was confirmed that this device was substantially equivalent to the predicate device in terms of the effectiveness and performance." Specifically, the following tests are mentioned:

• Tensile bond strength test
• Fluoride releasing property

The results of these tests "exhibited almost the same results for the subject device indicating that the subject device was as effective as and performs as good as or better than the predicate device."

Without the full study reports, which are not included in this summary, the detailed information requested cannot be fully extracted. However, based on the provided text, here's what can be inferred:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in the provided summary.
• Data Provenance: Not specified in the provided summary.
  • The submitter is Kuraray Medical Inc., located in Japan, suggesting the studies likely originated from there, but this is an inference, not stated directly about the data itself.
  • The studies were part of a 510(k) submission, typically involving prospective testing for performance evaluations.

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 as the tests described (tensile bond strength, fluoride release) are objective laboratory measurements, not subjective evaluations requiring expert ground truth in the way medical imaging interpretation might.

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

• Not applicable for objective laboratory measurements like tensile bond strength or fluoride release.

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 type of study is not mentioned. The device is a dental bonding agent, not an AI-powered diagnostic tool for human readers.

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

• Not applicable. The device is a physical product (dental bonding agent), not an algorithm. Its performance is inherent to the material properties.

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

• For Tensile Bond Strength and Fluoride Releasing Property: The "ground truth" would be the direct measurement of these physical/chemical properties using established laboratory testing protocols, likely aligned with ISO or ASTM standards, and validated against the performance of predicate devices.
• For Biocompatibility: The ground truth was established by evaluation against ISO 10993 series and ISO 7405 standards.

8. The sample size for the training set

• Not applicable. The description refers to a medical device (dental bonding agent), not an AI algorithm that requires a training set. Development of such a product involves formulation and testing, but not in the "training set" sense for AI.

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

• Not applicable as there is no "training set" in the context of this device.

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1. Direct restorations for anterior and posterior teeth (Class I - V cavities)
2. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
3. Intraoral repairs of fractured crowns/bridges

CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR section 872 since it is composed of materials such as 2,2'-Bis-[p-( Y -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA). According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, res orative and luting materials", this device is classified into the following: -Type 1: polymer-based filling and restorative materials; - Class 2: materials whose setting is effected by light; - Group 1: materials whose use requires the energy to be applied intra-orally.

The provided text describes a 510(k) summary for a dental restorative material, CLEARFIL MAJESTY Posterior. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study of its own with specific acceptance criteria and performance metrics in the way one might expect for a diagnostic AI device.

Therefore, the requested information components related to an AI device's performance study (such as sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this document. This document primarily addresses the chemical composition, intended use, and compliance with general dentistry standards (ISO 4049:2000).

Here's an attempt to extract and frame the relevant information based on the provided text, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are implied by compliance with established industry standards and substantial equivalence to predicate devices, rather than specific performance metrics measured in a clinical study as would be seen for a diagnostic AI.

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

• Not Applicable: This document does not describe a performance study with a "test set" in the context of an AI device. The equivalence is based on material properties and chemical composition.

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

• Not Applicable: No ground truth establishment by experts for a test set is mentioned.

4. Adjudication method for the test set

• Not Applicable: No test set or adjudication method is described.

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 is not an AI device, and no MRMC study was conducted.

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

• Not Applicable: This is not an AI device.

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

• Not Applicable: The "ground truth" for this submission revolves around chemical composition, material properties, and compliance with ISO standards, evaluated against existing predicate devices and recognized standards, rather than clinical outcomes or diagnostic accuracy.

8. The sample size for the training set

• Not Applicable: This is not an AI device and does not involve a training set.

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

• Not Applicable: This is not an AI device and does not involve a training set.

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CLEARFIL MAJESTY Flow is indicated for the following restorative applications:

• Direct restorations for anterior and posterior teeth (Class I III, V cavities, cervical caries, root erosion)
• Cavity base / liner
• Intraoral repairs of fractured crowns / bridges / composite resin

CLEARFIL MAJESTY Flow is a flowable, radiopaque restorative composite resin which provides true to life color matching, high polish ability and excellent physical properties, making ideal for both anterior and posterior restorations. CLEARFIL MAJESTY Flow can be used alone or together with CLEARFIL AP-X and CLEARFIL MAJESTY Esthetic. It is classified into tooth shade resin materia" (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as methacrylate monomers.

This 510(k) summary describes a dental restorative material, not a software or AI-enabled device, and therefore the requested information regarding AI-specific evaluations (such as sample sizes for test and training sets, expert adjudication methods, MRMC studies, or standalone performance) is not applicable or extractable from the provided text.

The acceptance criteria and study information provided in the document pertain to the physical and chemical properties of a dental resin material.

1. Table of Acceptance Criteria and Reported Device Performance

Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is an evaluation against the ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" consensus standard.

2. Sample size used for the test set and the data provenance:
Not applicable as this is a material science study adhering to an ISO standard, not a data-driven AI study.

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. The ground truth is established by the ISO standard's defined tests and methodologies for material properties, not by expert interpretation of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Testing is based on standardized physical and chemical measurements according to ISO 4049:2000.

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, an MRMC study was not done as this is a material science study, not an AI-assisted diagnostic or interpretive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's performance is compliance with the specified physical and chemical property requirements outlined in the ISO 4049: 2000 standard for dental polymer-based restorative materials.

8. The sample size for the training set:
Not applicable as this is a material science study, not a machine learning study.

9. How the ground truth for the training set was established:
Not applicable as this is a material science study. The "ground truth" for material properties is inherent in the internationally recognized ISO standard and its associated test methods.

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SURFACE COAT is used to glaze/polish following restorations:

• Direct and indirect composite resins
• Acrylic provisional crowns and bridges
• Acrylic appliances
• Glass ionomers and resin-modified glass ionomers

SURFACE COAT is a single-component, light-cure resin glaze material that provides a clear and smooth surface, consisting of a multi-functional acrylate monomer that provides excellent durability and may reduce or even eliminate the need for manual polishing. SURFACE COAT has virtually no surface oxygen inhibition layer.

The provided 510(k) summary for K063228 (SURFACE COAT) does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving the device meets those criteria.

This document is a 510(k) premarket notification, which largely focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria in the manner you've outlined for clinical or diagnostic devices.

However, based on the available information, I can extract and infer some aspects:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "Since there is no applicable FDA's recognized standard or international standard concerning performance of this type of device, certain specifications are designed for SURFACE COAT, the applicant device, and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent to the predicate devices in terms of the effectiveness and performance."

This indicates that internal specifications were used, but these specific specifications and their corresponding performance metrics are not detailed in this 510(k) summary. It only mentions that the device was tested accordingly and validated against predicate devices for effectiveness and performance.

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

• Sample size for test set: Not specified.
• Data provenance: Not specified. Since it's a materials science submission, it's highly likely to be laboratory/bench testing data rather than patient data from a specific country, and thus, "retrospective or prospective" would not apply in the typical clinical sense.

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

• This type of information (experts establishing ground truth) is typical for clinical studies involving diagnosis or interpretation. For a dental material, "ground truth" would likely be established through objective laboratory measurements and material science standards/tests, not expert consensus in the diagnostic sense.
• Not applicable/Not specified.

4. Adjudication Method for the Test Set

• Not applicable/Not specified for this type of material performance testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No. This type of study is for diagnostic devices involving human readers interpreting images or data. It is not relevant for a dental resin glaze material.

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

• Not applicable. This device is a material, not a software algorithm.

7. The Type of Ground Truth Used

• For a material like "SURFACE COAT," the "ground truth" would be established by the physical and chemical properties of the material as measured by standardized laboratory methods (e.g., tests for hardness, wear resistance, bond strength, surface smoothness, oxygen inhibition layer thickness).
• The document implies these were internal "specifications" and comparisons to predicate devices for "effectiveness and performance."

8. The Sample Size for the Training Set

• Not applicable/Not specified. The concept of a "training set" is usually for machine learning algorithms. For material development, various formulations and batches might be tested during R&D, but this isn't typically referred to as a "training set" in the context of regulatory submissions for materials.

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

• Not applicable/Not specified.

Summary of Study Information (as inferable from the document):

The submission relies on demonstrating substantial equivalence to predicate devices (BISCOVER LIQUID POLISH, BISCOVER LV, etc.) rather than a full de novo performance study against explicit acceptance criteria.

The study performed was a comparison of the SURFACE COAT's effectiveness and performance characteristics against those of the predicate devices. The exact nature of these tests (e.g., specific mechanical properties tested, methods used) and their quantitative results are not disclosed in this summary. The manufacturer states that "certain specifications are designed for SURFACE COAT...and tested accordingly in comparison with the predicate devices validating that the applicant device is substantially equivalent." This implies bench testing to show similar or superior material properties relative to the predicates.

In essence, the "study" for this 510(k) demonstrated that the new device performs sufficiently similar to already approved devices, making it substantially equivalent, without needing to define new, explicit clinical acceptance criteria in the format you requested.

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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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1. Direct filling restorations using light-cure or chemical-cure composite resin
2. Bonded amalgam restorations
3. Treatment of hypersensitive and/or exposed root surfaces
4. Cavity sealing as a pretreatment for indirect restorations
5. Intraoral repairs of facing crowns using light-cure composite resin
6. Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

CLEARFIL LINER BOND 2V 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. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to marketed under its 510 (k) notification submission.

This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial.

The provided text is a 510(k) Pre-Market Notification for a dental adhesive system, CLEARFIL LINER BOND 2V. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through extensive clinical trials with acceptance criteria and detailed device performance outcomes against those criteria in the way a novel medical device might.

Therefore, the requested information categories (1-9) which are typically used to describe the acceptance criteria and study proving device performance for a novel device, are largely not applicable in the context of this 510(k) submission.

Here's an analysis of why and what information is available:

First, understanding the context:

• 510(k) Submission: This is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as, i.e., "substantially equivalent" to, a legally marketed predicate device. It does not require clinical trials to establish new safety and efficacy, but rather to show that the new device does not raise different questions of safety and effectiveness than the predicate device.
• Predicate Device: CLEARFIL LINER BOND 2V is being compared to several predicate devices, with CLEARFIL LINER BOND 2 (K943170) being the primary one mentioned for technological improvement.

Let's address each point based on the provided text:

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

   • Not Applicable in this context. For a 510(k), specific "acceptance criteria" for clinical performance (e.g., a certain sensitivity/specificity threshold) are generally not established in the same way as for a novel device requiring new efficacy data. Instead, the focus is on showing equivalence in composition, function, and intended use, often supported by bench testing and biocompatibility.
   • The document primarily describes a biocompatibility study for a new chemical ingredient (DMABB), not a clinical performance study against specific acceptance criteria.
   • Reported performance (Biocompatibility of DMABB):

     Test Type	Acceptance Criteria (Implied)	Reported Device Performance
     Acute Toxicity (LD50)	No significant toxicity at doses relevant to exposure.	Not less than 4,000 mg/kg (Mouse, Oral, 10 days) - Negative
     Genotoxicity	No mutagenic effects.	Negative (Ames test, 5 bacterial species, with/without S-9 mix)
     Sensitization	No evidence of allergic or hypersensitivity reactions.	Negative (Maximization Sensitization Test)
     Leachables (DMABB)	Amount leached should be below toxicologically relevant levels.	Less than identification limit (0.04 ppm) in distilled water (at 37℃ and 50℃ for 24 hours)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Test Set Sample Size:
     • Acute Toxicity: Mouse (number not specified, but typically a group for dose-response).
     • Genotoxicity: Not applicable, as this is a laboratory test on bacterial cultures.
     • Sensitization: Not applicable, as this is a laboratory test, likely on animals (e.g., guinea pigs for maximization test), but the count is not specified.
     • Leachables: "Two pieces of cured resin" were used.
   • Data Provenance: Not explicitly stated, but assumed to be from internal Kuraray studies, likely conducted in Japan (the submitter's country). The studies are prospective in nature for these specific tests.

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. For biocompatibility and chemical leachable studies, ground truth is established through standardized laboratory methods (e.g., ISO standards, Ames test procedures, HPLC analysis) and observed biological responses, not an expert panel.

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

   • Not Applicable. Adjudication methods are relevant for subjective interpretations (e.g., image reading) or complex clinical endpoints. For the objective, quantitative lab tests described (LD50, genotoxicity, sensitization, leachable quantification), no adjudication method is used.

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 adhesive, not an AI-powered diagnostic tool requiring human reader studies.

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

   • Not Applicable. This device is a dental adhesive, not an algorithm.

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

   • Ground Truth for Biocompatibility/Chemical Tests:
     • Acute Toxicity: Live animal response (survival, clinical signs) to a chemical dose.
     • Genotoxicity: Presence/absence of mutations in bacterial strains, assessed against negative and positive controls.
     • Sensitization: Dermal reactions in test subjects/animals.
     • Leachables: Quantitative chemical analysis (High Pressure Liquid Chromatography - HPLC) for the presence and concentration of DMABB.

8. The sample size for the training set

   • Not Applicable. No machine learning or AI is involved in this device, so there is no "training set."

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

   • Not Applicable. As no training set exists, this question is irrelevant.

Summary for this 510(k) Submission:

The provided document details a 510(k) submission, whose primary goal is to demonstrate substantial equivalence to existing predicate devices. Therefore, it focuses on comparing the new device's composition, intended use, and technological characteristics to those of legally marketed devices.

The "study that proves the device meets the acceptance criteria" in this context refers to biocompatibility testing conducted on a new chemical ingredient (DMABB) introduced in CLEARFIL LINER BOND 2V, which was not present in previously approved Kuraray products. These tests (acute toxicity, genotoxicity, sensitization, and leachable analysis) aim to show that this new ingredient does not pose new safety concerns, thereby supporting the overall substantial equivalence of the new device to its predicates. The "acceptance criteria" are generally implied by the negative results, indicating the absence of adverse toxicological effects or leachable levels above identification limits, consistent with standard biocompatibility assessments for medical devices.

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