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The TOKUYAMA UNIVERSAL BOND II is indicated for:

• Direct anterior and posterior restorations with light-curing, dual-curing, and self-curing composite materials
• Intraoral repair of composite restorations, porcelain fused to metal, metal, and all-ceramic restorations without an additional primer
• Cementation of indirect restorations and veneers when combined with light-cure, dual-cure, and self-curing resin cements
• Bonding of core build-ups made of core build-up materials
• Bonding of denture resin to metal base, clasp or attachment
• Repair of denture with metal base, clasp or attachment
• Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns

The TOKUYAMA UNIVERSAL BOND II device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch and total-etch techniques. As a universal adhesive, TOKUYAMA UNIVERSAL BOND II has been designed to be fully compatible with light-cured, self-cured and dual-cured composite materials.
TOKUYAMA UNIVERSAL BOND II contains phosphoric acid monomer, bisphenol A di(2-hydroxy propoxy) dimethacrylate (Bis-GMA), triethylene glycol dimethacrylate (TEGDMA), 2-Hydroxyethyl methacrylate (HEMA), MTU-6 (thiouracil monomer), silane coupling agent, peroxide, borate catalyst, acetone, ethanol and purified water.
Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrated by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends.
The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.
The TOKUYAMA UNIVERSAL BOND device does not come sterilized and is not intended to be sterilized prior to use.

The provided document describes the TOKUYAMA UNIVERSAL BOND II, a dental adhesive. The acceptance criteria and the study to prove the device meets these criteria are outlined through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes (number of replicates or specimens) used for each tensile bond strength test. However, it indicates that testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015. This ISO standard typically specifies details on sample preparation and testing procedures.

The data provenance is not explicitly stated in terms of country of origin, but the submitting company is Tokuyama Dental Corporation, located in Tokyo, Japan. The testing is non-clinical bench testing, so it is retrospective in the sense that it evaluates the manufactured device's performance.

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

Not applicable. This is a non-clinical bench testing study for a dental adhesive, not a study involving diagnostic interpretation or human expert judgment to establish ground truth for a test set. The ground truth for performance is objective physical measurements based on established ISO standards.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this is non-clinical bench testing with objective physical measurements. There is no subjective adjudication required.

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 a non-clinical study for a dental adhesive, not an AI-assisted diagnostic device.

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

Not applicable. This is a non-clinical study for a dental adhesive, not an algorithm. The device's performance is measured standalone from human intervention other than its application as per the instructions for use.

7. The Type of Ground Truth Used:

The ground truth used for performance evaluation is objective physical measurements of tensile bond strength and working time, compared against pre-defined in-house specifications (derived from the predicate device) and ISO standards. Biocompatibility was also assessed in accordance with ISO 10993-1:2009.

8. The Sample Size for the Training Set:

Not applicable. This device is a dental adhesive, not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML algorithm, there is no training set or associated ground truth establishment process.

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For use as a tooth shade resin material in dental procedures such as:

• Direct anterior and posterior restorations
• Cavity base or liner
• Blocking out cavity undercuts before fabricating indirect restorations
• Repair of porcelain/composite

The OMNICHROMA FLOW BULK is a low viscosity, light-cured, radiopaque composite tooth shade resin material for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA FLOW BULK device is a single shade material. Direct placement of the OMNICHROMA FLOW BULK device into a prepared cavity allows for easily handling. The OMNICHROMA FLOW BULK device is a flowable material which can be placed in 3.5mm increments.
The OMNICHROMA FLOW BULK device contains 1,6-bis(methacrylethyloxycarbonylamino)trimethyl hexane (UDMA), triethylene glycol dimethacrylate (TEGDMA), mequinol, dibutyl hydroxyl toluene, and UV absorber.
OMNICHROMA FLOW BULK is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm.
The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.

The provided document outlines the substantial equivalence of OMNICHROMA FLOW BULK, a tooth shade resin material, to existing predicate devices. It does not describe an AI medical device or a study involving human readers or AI assistance. Therefore, I cannot provide details on acceptance criteria or study elements related to AI performance, multi-reader multi-case studies, or ground truth establishment in the context of an AI device.

The document focuses on the physical and chemical properties of the dental resin and its compliance with ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials."

Here's an analysis of the provided text in relation to your request, highlighting where information is absent for an AI device:

Acceptance Criteria and Device Performance (for a physical dental material):

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

The acceptance criteria for the OMNICHROMA FLOW BULK device are its conformity to the requirements of ISO 4049:2009. The reported device performance for all tested physical properties (Sensitivity to ambient light, Depth of cure, Flexural strength, Water sorption, Solubility, Color stability, Radio-opacity) is that it "Conformed to the requirement of ISO 4049".

Since this document describes a dental material and not an AI model, the following points of your request are not applicable or information is not present in the provided text.

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

• The document states "Non-clinical testing of the physical properties of the OMNICHROMA FLOW BULK device was conducted in accordance with ISO 4049:2009". It does not specify the sample size (e.g., number of material samples tested) for each physical property.
• Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned as this is materials testing, not patient data.

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. Ground truth in this context refers to the defined physical and chemical properties as measured in a lab according to ISO standards, not expert consensus on medical images.

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

• Not applicable. No expert adjudication is described for material property testing.

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.

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

• Not applicable. This is not an AI algorithm.

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

• For material properties, the "ground truth" is established by highly controlled laboratory measurements and adherence to the specifications outlined in the international standard ISO 4049:2009.

8. The sample size for the training set:

• Not applicable/not specified. The device is a physical material, not an AI model requiring a training set.

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

• Not applicable. There is no training set mentioned or implied for this submission.

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The device is indicated for use for direct anterior and posterior restorations, cavity base or liner, and repair of porcelain/ composite.

The OMNICHROMA FLOW tooth shade resin material is a paste that comes in a plastic syringe (1.8mL). The device is a low viscosity, light-cured, radiopaque composite resin for use in anterior and posterior restorations for all carious classes. OMNICHROMA FLOW is a single shade material. Direct placement of OMNICHROMA FLOW into a prepared cavity allows for easy handling.

OMNICHROMA FLOW is designed to be cured by either a halogen or LED curing-light with a wavelength of 400-500 nm. Be sure to light-cure OMNICHROMA FLOW extra-orally and check the time needed for complete hardening of OMNICHROMA FLOW with your lightcuring unit before performing the bonding procedure.

The device is intended for use by licensed healthcare professionals only. The device does not come sterilized and is not intended to be sterilized prior to use.

The OMNICHROMA FLOW device contains methacrylic monomers and a UV absorber. The device should not be used on patients who are allergic to or hypersensitive to methacrylic and related monomers, UV absorber, or any of the other ingredients.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the OMNICHROMA FLOW tooth shade resin material.

Here's the breakdown of the information requested:

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)

The document does not explicitly state the specific sample sizes for each physical property test. It mentions that "Non-clinical testing of the physical properties of the OMNICHROMA FLOW device was conducted in accordance with ISO 4049:2009, 'Dentistry -- Polymer-based Restorative Materials.'" The ISO standard would define the required sample sizes for each test.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by or for Tokuyama Dental Corporation, a Japanese company.

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 information is not applicable. The device is a "tooth shade resin material," and its performance is evaluated against engineering standards (ISO 4049) and biocompatibility, not by expert interpretation of images or clinical outcomes that would require ground truth established by medical experts like radiologists.

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

This information is not applicable as the study involves physical property testing against an engineering standard, not clinical adjudication of diagnoses or interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a dental restorative material, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical material, not an algorithm. The performance testing was of the material itself.

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

The ground truth for the physical property testing is based on the requirements and methodologies outlined in ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials," which are standardized engineering and material science criteria. For biocompatibility, the ground truth is established by standard biological evaluation methods (cytotoxicity, sensitization, oral mucosa irritation, subacute systemic toxicity, acute systemic toxicity, and genotoxicity testing).

8. The sample size for the training set

This information is not applicable. The device is a physical material, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable for the reason stated in point 8.

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The TOKUYAMA REBASE III device is for relining dentures and extension of denture borders.

The TOKUYAMA REBASE III device is an acrylic resin used for chairside hard denture linings and extension of denture borders. The powder contains poly(ethyl methacrylate) and benzoyl peroxide. The liquid contains methacrylate monomer. The REBASE adhesive contains ethyl acetate, acetone and methacrylate polymer. The REBASE adhesive is used solely for bonding to acrylic surfaces, and cannot be used to bond nylon, metal, and silicone surfaces, etc. The device is composed of both a powder and liquid that is cured by chemical polymerization. The powder is packaged in a plastic bottle, and the liquid is packaged in a glass bottle. A group of polymerization agents of the device is contained in the powder and liguid separately to avoid the reaction during storage, and the polymerization reaction starts by mixing the powder and liquid. The device is cured by polymerization of methacrylic monomers contained in the liquid. The TOKUYAMA REBASE III kit contains powder, liquid, REBASE adhesive, TOKUSO RESIN HARDENER II, and other accessories, namely, a measuring cup, dropper, rubber cup, spatula, drip nozzle, drip cup, brush, and spoon. The device does not come sterile and is not intended to be sterilized prior to use. The powder comes in "fast" and "normal" depending on the desired setting time, and in three shades designated as Light Pink, Pink, and Live Pink.

The provided document is a 510(k) premarket notification for a medical device called "TOKUYAMA REBASE III," which is a denture relining, repairing, or rebasing resin. It aims to demonstrate substantial equivalence to a predicate device. The information requested regarding acceptance criteria and study details for an AI/ML device is not directly applicable to this type of submission for a physical material.

However, I can extract the relevant information from the document considering the nature of the device (a material used in dentistry):

1. Table of Acceptance Criteria and Reported Device Performance:

The document refers to adherence to international and Japanese standards for physical properties. Instead of a direct "acceptance criteria" table in the context of AI/ML performance metrics (like sensitivity, specificity), the acceptance is based on meeting the requirements of these standards.

2. Sample Size for Test Set and Data Provenance:

The document does not specify exact "sample sizes" for the material testing in the way an AI/ML study would specify test cases. Instead, it indicates that testing was performed "based on ISO 20795-1: 2013" and "in accordance with JIS T 6521:2005," implying adherence to the sample size and methodology requirements of these standards. The data provenance is not explicitly stated as country of origin of data or retrospective/prospective, but it refers to tests conducted by Tokuyama, the device manufacturer.

3. Number of Experts and Qualifications:

Not applicable. This is a material science and biocompatibility assessment, not a diagnostic or AI-assisted interpretation task involving expert readers.

4. Adjudication Method:

Not applicable. The evaluation is based on objective measurements against specified standards for material properties.

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

No. This is a 510(k) submission for a physical material, not an AI-assisted diagnostic device that would involve human readers.

6. Standalone (Algorithm Only) Performance:

Not applicable. There is no algorithm or AI component in this device.

7. Type of Ground Truth Used:

The "ground truth" for this device consists of established international (ISO 20795-1: 2013, ISO 10993-1: 2009) and national (JIS T 6521:2005) standards for dental materials. Compliance with these standards using specified test methods serves as the basis for performance evaluation and safety.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. There is no training set for this device.

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The ESTELITE UNIVERSAL FLOW device is indicated for use as a tooth shade resin material in dental procedures, such as:

• Direct anterior and posterior restorations
• Cavity base or liner
• Blocking out cavity undercuts before fabricating indirect restorations
• Repair of porcelain/composite

The ESTELITE UNIVERSAL FLOW tooth shade resin device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations. The device incorporates Radical-Amplified Photopolymerization initiator technology (RAP technology), which facilitates a shortened light curing time and ample working time.
ESTELITE UNIVERSAL FLOW comes in three viscosities: High, Medium, and Super Low. The device is available in either a syringe or pre-loaded tip. Each type contains spherical silica-zirconia filler and composite filler. The spherical filler has mean particle size of 200 and a particle size range of 100 to 300 nm.
The device does not come sterilized and is not intended to be sterilized prior to use.

Here's a breakdown of the acceptance criteria and study information for the ESTELITE UNIVERSAL FLOW device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample sizes used for the non-clinical tests (e.g., how many specimens were tested for flexural strength). It only states that the testing was conducted in accordance with ISO 4049:2009. ISO standards typically specify minimum sample sizes for such tests.

The data provenance is non-clinical testing conducted by the manufacturer, Tokuyama Dental Corporation. The country of origin of the data is not specifically mentioned, but the manufacturer is based in Japan. This testing is prospective for the ESTELITE UNIVERSAL FLOW device, as it was performed to demonstrate conformity.

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

Not applicable. This device is a dental material, and the "ground truth" for its performance characteristics is established by adherence to physical and chemical property standards (ISO 4049:2009), not by expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. The "test set" involves physical and chemical property measurements against a standard, not interpretations requiring 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 dental restorative material, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance claims is the requirements specified in ISO 4049:2009, "Dentistry -- Polymer-based Restorative Materials." The device's physical and chemical properties were measured and compared against these established international standards.

For biocompatibility, the ground truth relies on the established safety record of identical ingredients used in previously authorized devices (ESTELITE BULK FILL Flow, ESTELITE SIGMA QUICK, and ESTELITE FLOW QUICK) over many years without reportable adverse incidents. This is justification for not requiring further biocompatibility testing under Section 6 of ISO 10993-1.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable, as no training set was used.

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For use as a tooth shade resin material in dental procedures, such as:

• Direct anterior and posterior restorations
• Direct bonded composite veneer
• Diastema closure
• Repair of porcelain/composite

The OMNICHROMA device is a light-cured, radiopaque composite resin for use in anterior and posterior restorations and is indicated for all carious classes. The OMNICHROMA device is available in only one shade.

The device does not come sterilized and is not intended to be sterilized prior to use.

The provided text describes the 510(k) premarket notification for the OMNICHROMA tooth shade resin material. It does not contain information about a comparative effectiveness study involving AI or human readers, nor does it detail acceptance criteria and performance data in the context of an AI device. The document is for a dental restorative material, not an AI-powered diagnostic or assistive device.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance related to an AI device.
• Sample sizes, data provenance, and expert details for a test set for an AI device.
• Adjudication methods for an AI device's test set.
• MRMC study details or effect sizes for human readers with/without AI assistance.
• Standalone performance for an AI algorithm.
• Ground truth types in the context of AI.
• Training set sample size and ground truth establishment for an AI device.

The provided document focuses on the physical and chemical properties of a dental resin and its substantial equivalence to a predicate device based on non-clinical testing according to ISO 4049. There is no mention of AI, diagnostic performance, or human reader studies.

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The TOKUYAMA UNIVERSAL BOND is indicated for:

• Direct anterior and posterior restorations with light-curing, and self-curing composite materials

• Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without an additional primer

• Cementation of indirect restorations and veners when combined with light-cure, and self-curing resin cements

• Bonding of core build-ups made of core build-up materials

• Bonding of denture resin to metal base, clasp or attachment

• Repair of denture with metal base, clasp or attachment

• Bonding of opaque resin to a metal base in the fabrication of resin-faced crowns

The TOKUYAMA UNIVERSAL BOND device is a two-component self-cured dental adhesive system for both direct and indirect restorations that can be used with self-etch, selective-enamel-etch, and total-etch techniques. The TOKUYAMA UNIVERSAL BOND device is fully compatible with light-cured. self-cured, and dual-cured composite materials.

Bond A and Bond B are packaged in separate plastic bottles. A group of polymerization agents is contained in the Bond A and Bond B to avoid reaction during storage, and the polymerization reaction begins upon mixing. When the mixture is applied thinly to adherends and concentrate by air-drying, a cured layer is formed by polymerization of methacrylic monomers. The cured layer functions as an adhesive layer for enhancing adhesiveness of polymerization resin to the adherends.

The device improves the bond strength of polymerizable resin material (adhesive resin cement, acrylic resin, and composite resin) to indirect restorative materials such as glass-ceramics (porcelain), oxide-ceramics (zirconia and alumina), metals (precious and non-precious), and resin materials including inorganic filler.

The provided document is a 510(k) premarket notification for a dental adhesive device, the TOKUYAMA UNIVERSAL BOND. It describes the device, its intended use, technological characteristics, and non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

However, the document does NOT describe an AI/ML-based medical device. Therefore, it does not contain the information required to answer the questions about acceptance criteria, study design for AI models (sample size, data provenance, ground truth, expert adjudication, MRMC studies, standalone performance, training set details).

The Acceptance Criteria and Study Proof for the TOKUYAMA UNIVERSAL BOND device are entirely based on physical property testing as it is a material-based dental product, not an AI diagnostic or assistance tool.

Here's a summary of the acceptance criteria and proof as presented for this specific dental device:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TOKUYAMA UNIVERSAL BOND device are based on achieving certain tensile bond strengths to various dental materials, as well as satisfactory working time, paintability, and appearance.

(Note: The tables in the original document present the performance of the predicate and reference devices against the same specifications, with all devices meeting these criteria.)

Study that Proves the Device Meets the Acceptance Criteria:

The study conducted is a series of non-clinical, benchtop physical property tests.

1. Sample size used for the test set and data provenance:

   • The document does not explicitly state the sample size (number of individual samples or replicates tested) for each physical property. It only states that "Non-clinical testing of the following physical properties was conducted."
   • Data Provenance: The tests were conducted by Tokuyama Dental Corporation, based in Japan. This implies the data originates from their internal laboratory testing. The data is retrospective in the sense that it was generated prior to the 510(k) submission.

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

   • Not applicable. For physical property testing of a dental material, "ground truth" is established by the direct measurement of physical properties (e.g., bond strength in MPa) using established testing standards (ISO/TS 11405:2015). This does not involve human expert adjudication or consensus in the way an AI diagnostic would require for image interpretation.

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

   • Not applicable. As this is a physical property test, not an interpretive one, there is no adjudication process involving multiple human readers. The measurement results are directly compared against the pre-defined in-house specifications.

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 device is a material, not an AI or a system that assists human readers. Therefore, an MRMC study is irrelevant.

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

   • Not applicable. This device has no algorithm and does not perform any diagnostic or interpretive function. Its performance is intrinsic to its physical and chemical properties.

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

   • The "ground truth" for this device's performance is the direct, quantitative measurement of physical properties (tensile bond strength) and qualitative assessments (working time, paintability, appearance) against pre-defined, standardized specifications. The testing was conducted pursuant to Section 5.1 of ISO/TS 11405:2015 for tensile bond strength tests.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. There is no training set for this type of device.

In summary, the provided document pertains to a dental bonding agent, and therefore the "acceptance criteria" and "proof" relate to its physical and chemical characteristics and performance as a material, rather than the statistical or clinical performance metrics associated with AI/ML medical devices.

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The TOKUYAMA CUREGRACE device is an acrylic resin used in a variety of dental applications such as:

• Temporary inlay, crowns and bridges
• Repair of broken or cracked dentures
• Denture border extension
• Replacement of lost denture teeth
• Adjustment of the occlusal height of resin teeth

The TOKUYAMA CUREGRACE device is a self-curing acrylic dental resin used for denture relining, repairing, or rebasing and for temporary crowns and bridges. The device is composed of powder and liquid that is cured by chemical polymerization. The powder is packaged in a plastic bottle, and the liquid is packaged in a glass bottle. The powder comes in four shades designated as A2, A3, Pink, and Live Pink. The device does not come sterile and is not intended to be sterilized prior to use. The TOKUYAMA CUREGRACE device comes with a measuring cup for measuring the powder component and a dropper for dispensing the liquid component.

I am sorry, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a dental resin, focusing on its substantial equivalence to predicate devices and non-clinical testing. It explicitly states that "There were no clinical tests performed for the TOKUYAMA CURECRACE device."

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance directly from a study, as no clinical study proving the device meets acceptance criteria is described. The acceptance criteria in this context would be showing substantial equivalence to predicate devices through material properties and non-clinical tests.
2. Sample size used for the test set or data provenance for a clinical study.
3. Number of experts used to establish ground truth or their qualifications for a clinical study.
4. Adjudication method for a clinical study.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on standalone performance of an algorithm.
7. The type of ground truth used from a clinical study.
8. The sample size for the training set from a clinical study.
9. How the ground truth for the training set was established from a clinical study.

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For use as a tooth shade resin material in dental procedures, such as:

• Direct anterior and posterior restorations
• Cavity lining
• Blocking out cavity undercuts before fabricating indirect restorations
• Repair of porcelain/composite

ESTELITE BULK FILL Flow is a low viscosity, light cured radiopaque composite dental tooth shade resin material. This low stress flowable material can be placed in 4 mm increments. The device incorporates Radical-Amplified Photopolymerization (RAP) initiator technology, which facilitates a shortened light curing time and ample working time. The device comes in five shades, namely U (Universal), A1, A2, A3, and B1.

This document describes the premarket notification (510(k)) for the Tokuyama Dental Corporation's "ESTELITE BULK FILL Flow tooth shade resin material." The FDA determined the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document provides a table comparing the new device (ESTELITE BULK FILL Flow) to its primary predicate (ESTELITE FLOW QUICK) and references ISO 4049:2009 for many properties.

Note: The document explicitly states "Conformed to the requirement of ISO 4049" for several physical properties, implying these are the acceptance criteria and the device met them. For other properties, the predicate's performance serves as the benchmark for substantial equivalence.

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

The document does not explicitly state the sample sizes used for the non-clinical physical property tests. It only states that the testing was "conducted in accordance with ISO 4049:2009," which would imply adherence to its specified sample sizes if applicable.

The provenance of the data is implied to be from Tokuyama Dental Corporation, which is based in Japan, as per the submitter information. The testing is non-clinical, so the retrospective/prospective distinction for human data is not applicable.

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 information is not applicable as the studies conducted were non-clinical, measuring physical properties of the material in a laboratory setting, not evaluating diagnostic performance with human judgment.

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

This information is not applicable as there were no human expert judgments or adjudications involved in establishing the ground truth for the physical property 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

No. An MRMC comparative effectiveness study was not done. The device is a dental material, not an AI-assisted diagnostic tool. The document states: "There were no clinical tests performed for the ESTELITE BULK FILL Flow device."

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

Yes, in a sense, a standalone assessment of the material's properties was performed by conducting non-clinical physical property tests. However, this is not a "standalone algorithm" in the context of AI. It refers to the intrinsic performance of the material itself.

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

The ground truth for the performance data of the device was established through laboratory measurements of physical properties according to published standards (ISO 4049:2009). For biocompatibility, the ground truth was based on prior FDA authorization of the device's ingredients in other similar devices and the historical absence of adverse events.

8. The sample size for the training set

This information is not applicable. The device is a dental material, not an AI/ML algorithm that requires a training set. The performance data presented are from testing the physical properties of the final product.

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

This information is not applicable as there was no training set for an AI/ML algorithm.

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The ESTECEM device is an adhesive resin cementation of crowns, bridges, inlays, and onlays made of glass/oxide ceramics (porcelain, zirconia and alumina), metals/alloys (precious) and resin materials including inorganic filler (composite materials). The ESTECEM device is indicated for:

• Repair of fractured porcelain fused to metal crowns and all ceramic restorations

• Cementation of veneers

• Cementation of adhesion bridges

• Cementation of metal or resin cores, metal or glass-fiber posts

The ESTECEM device is a dual-cure (light and/or self-cure), radiopaque, adhesive resin cement system with excellent handling, esthetic and adhesive properties to teeth and all prosthetic materials. The main components of the ESTECEM device are (1) the paste (A/B) and (2) primer kit. The paste and primer are packaged in plastic syringes and plastic bottles, respectively. The device also comes with a mixing dish (dispensing well), disposable applicator, and cement mixing tip.

The paste is dispensed in an automix syringe and is available in various shades (universal, clear, brown and white-opaque). The primer kit components consist of ESTELINK (bond A/bond B) and Tokuyama Universal Primer (A/B). The ESTELINK bond promotes the adhesion of the paste to the tooth structure. The Tokuyama Universal Primer enhances the adhesion of the paste to prosthetic materials.

The ESTECEM device does not come sterilized and is not intended to be sterilized prior to use.

This document describes the premarket notification for the ESTECEM dental adhesive resin cement system. The acceptance criteria and the study proving the device meets these criteria are detailed in section "807.92(b)(1): Non-clinical Testing" and the "Predicate devices" table, primarily through non-clinical bench testing and comparison to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for ESTECEM are primarily demonstrated through non-clinical testing, comparing its performance to established standards (ISO 4049:2009, ISO 7405:2008) and the technological characteristics of predicate devices. The document does not provide a direct table of set acceptance values versus measured values for each criterion. Instead, it states that the ESTECEM device's material properties, principles of operation, and performance characteristics are comparable to the selected predicates and that it is as safe, as effective, and performs as well as or better than the predicate devices.

However, based on the non-clinical testing performed, we can infer the tested parameters as the acceptance criteria domains:

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

The document does not specify a distinct "test set" in the context of an AI/ML device. Instead, the performance was evaluated through non-clinical bench testing of the ESTECEM dental adhesive resin cement. The specific sample sizes for each physical property and biocompatibility test are not provided in this summary.

The data provenance is retrospective, as it involves laboratory testing of the manufactured device. The country of origin for the testing data is not explicitly stated, but the manufacturer, Tokuyama Dental Corporation, is based in Japan.

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

Not applicable. This is a medical device approval that relies on physical and chemical bench testing and biocompatibility assessments, not on expert adjudication of diagnostic outputs.

4. Adjudication Method for the Test Set

Not applicable. See point 3.

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 a dental material device, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a dental material device, not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was defined by established International Organization for Standardization (ISO) standards for dental materials. Specifically:

• Physical Properties: ISO 4049:2009
• Biocompatibility: ISO 7405:2008, ISO 10993-1:2009, ISO 10993-3 (genotoxicity), ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (systemic toxicity).

The performance of the ESTECEM device was compared against the requirements and typical performance characteristics of legally marketed predicate devices, implying that the established performance of these predicates served as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This is a dental material device and does not involve AI/ML models that require a training set.

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

Not applicable. See point 8.

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