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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] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation using a dual- or self-cured composite resin
[7] Core build-ups using a light-, dual- or self-cured core material
[8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement

The subject device is a two component, self-etch, light-cured bonding agent, which is intended for universal use for both direct and indirect restorations. The PRIMER allows simultaneous treatment of both dentin and enamel using one liquid. The product is activated by a dual-cure mechanism when the BOND is mixed with CLEARFIL DC Activator. This allows it to be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.

This document is a 510(k) summary for a dental bonding agent, CLEARFIL SE BOND 2. It's a regulatory submission to the FDA and therefore lacks the typical detailed study information you'd find in a peer-reviewed publication. Dental bonding agents are typically evaluated through benchtop tests rather than large-scale clinical studies with human readers, multi-reader multi-case studies, or complex ground truth requirements like pathology or outcomes data in the way medical imaging AI devices are.

However, I can extract the available information regarding acceptance criteria and the study performed, even if it's limited in scope compared to your requested format for AI/imaging devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document states there are no international standards for the performance of this type of device. Therefore, a comparative approach against predicate devices was used. The key performance metric mentioned is tensile bond strength.

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

• Sample Size for the Test Set: Not explicitly stated. The document mentions "certain tests were performed on this device" but does not detail sample sizes for these tests.
• Data Provenance: Not specified. Given it's a submission from a Japanese company (Kuraray Noritake Dental Inc.), the tests were likely conducted internally or by a contracted lab. The document does not specify if it's retrospective or prospective; however, these would be benchtop tests, not clinical studies in the typical sense.

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

• Number of Experts: Not applicable. For tensile bond strength and other physical/chemical properties of dental materials, the "ground truth" is established through standardized laboratory testing protocols, not by expert consensus or interpretation in the way medical images are.
• Qualifications of Experts: Not applicable in the context of expert review for ground truth. The tests would be performed by lab technicians or scientists following established ISO or internal protocols for material testing.

4. Adjudication Method for the Test Set

• Adjudication method: Not applicable. As ground truth is established through physical/chemical testing, there is no need for expert adjudication of results.

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

• MRMC Study: No. This is a dental material, not an AI or imaging device that involves human readers.

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

• Standalone Performance: Not applicable. This is a dental material, not an algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Physical/chemical properties determined through laboratory testing (specifically, tensile bond strength as mentioned). This is a direct measurement based on established test methodologies for material science, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Ground Truth for Training Set Establishment: Not applicable. There is no training set for this type of device.

Study Summary:

The study performed was a benchtop comparative effectiveness study where the tensile bond strength of the CLEARFIL SE BOND 2 was compared against its predicate devices. The study aimed to demonstrate that the subject device's performance was "not significantly different or not less than" that of the predicate devices in terms of tensile bond strength. This approach was taken because "there have not been any international standards concerning performance of this type of device." No specific details on the methodology, number of samples, or statistical analysis are provided in this summary. The safety evaluation was based on the chemical ingredients being equivalent to predicate devices with no reported post-market problems.

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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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CLEAFIL SE BOND is indicated for the following applications:

1. Direct filling restorations using light-curing composite 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 facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite
5. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

CLEARFIL SE BOND 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.

I am sorry, but the provided text is a 510(k) summary for a dental adhesive (CLEARFIL SE BOND), which focuses on demonstrating substantial equivalence to a predicate device for regulatory purposes. It does not describe a study that involves acceptance criteria for device performance in the context of diagnostic accuracy, AI, or human reader effectiveness.

Therefore, I cannot extract the information required to answer your request, such as a table of acceptance criteria and reported device performance related to a diagnostic study, sample sizes for test sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Ask a specific question about this device

CLEARFIL SE BOND is indicated for the following applications:

1. Direct filling restorations using light-curing composite 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 facing crowns made of porcelain, hybrid ceramics and cured composite resin
5. Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

CLEARFIL SE BOND 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 retentive materials.

Here's an analysis of the provided text regarding the acceptance criteria and study for CLEARFIL SE BOND, based on the information available in the 510(k) summary.

It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA. These summaries typically demonstrate substantial equivalence to previously cleared devices rather than presenting full clinical trial results with detailed acceptance criteria and standalone performance studies in the way a pharmaceutical drug or a high-risk medical device might. Therefore, some of the requested information (like specific effect sizes for MRMC studies, sample sizes for test sets, and detailed expert qualifications) is not explicitly present in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

While specific numerical values for acceptance thresholds are not provided, the reported performance is that the device met the implicit criterion of "substantial equivalence" in bond strength to the predicate device. |
| Chemical Ingredients and Safety: Chemical ingredients are identical or substantially equivalent to predicate devices and have a history of safe use. | The document states: "The chemical ingredients are identical or substantially equivalent to the predicated devices. These chemical ingredients have been used in similar products which have been marketed for many years, therefore they are safe." The safety of the chemical ingredients is affirmed by their historical use in equivalent predicate devices (CLEARFIL LINER BOND 2V (K974486), PANAVIA F (K983361), ESTENIA (K982164)). |
| Design, Composition, and Function: Device is similar and substantially equivalent in design, composition, and function to predicate devices. | The document explicitly states: "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." This is a general statement of equivalence rather than a specific performance metric. The device is also described as a "simplified system of CLEARFIL LINER BOND 2V". |
| Intended Use: Device performs as intended for specified indications. | The Indications For Use are listed and the claim is that the device is "substantially equivalent" for these uses to predicate devices. Implicitly, it is deemed to perform for: 1) Direct filling restorations, 2) Cavity sealing, 3) Treatment of hypersensitive/exposed root surfaces, 4) Intraoral repairs of fractured crowns, and 5) Surface treatment of prosthetic appliances. The "substantially equivalent" claim implies that it performs comparably to the predicate devices for these indications. |

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

The 510(k) summary does not specify the sample size used for the bond strength evaluations (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for these evaluations. These details are typically part of a more extensive study report, not a 510(k) summary.

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

This information is not provided in the 510(k) summary. Bond strength testing is usually a laboratory-based biomechanical evaluation, not typically reliant on "expert ground truth" in the way image interpretation or diagnostic accuracy studies might be. Therefore, experts in establishing ground truth in that context would not be applicable here. The "ground truth" would be the measured bond strength values themselves.

4. Adjudication Method for the Test Set

Not applicable for this type of biomechanical bond strength evaluation. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or diagnostic results, not for objective laboratory measurements like bond strength.

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. The device is a "Resin-based dental adhesive system," a physical material used in dentistry, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.

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

This is not applicable. As stated, the device is a dental adhesive system, not an algorithm. The "standalone performance" in this context would be the measured bond strength of the product itself under controlled laboratory conditions, which the document indicates was evaluated by comparing it to predicate devices.

7. The Type of Ground Truth Used

For the bond strength evaluations, the "ground truth" would be the measured bond strength values themselves, obtained through standardized laboratory testing methods (e.g., universal testing machine pulling apart bonded substrates). This is a direct physical measurement.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical product (dental adhesive), not a machine learning model that requires a training set.

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

This is not applicable, as there is no "training set" for this type of device.

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