[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 non-precious metal posts
[6] Post cementation and core build·ups using dual·cured composite resin CLEARFIL DC CORE PLUS
[7] Core build-ups using light-cured composite resin

Device Description

The subject device is a single-component. light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. A single dose of it comes in a container with an applicator tip for fast, direct placement into the cavity.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental bonding agent, CLEARFIL TRI-S BOND PLUS Single Dose. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on chemical ingredients, safety, and technological characteristics/performance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

Acceptance Criteria and Study Details for CLEARFIL TRI-S BOND PLUS Single Dose

The provided information focuses on demonstrating substantial equivalence to existing predicate devices rather than establishing novel safety or efficacy criteria that would necessitate a rigorous clinical trial with pre-defined acceptance criteria for a new device. For devices seeking 510(k) clearance, the "acceptance criteria" are generally that the new device performs "as good as or better than" the predicate device in key performance characteristics relevant to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence, formal, quantitative acceptance criteria with specific threshold values (e.g., "tensile strength > X MPa") are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" can be inferred as demonstrating similar or superior performance to the predicate devices.

Acceptance Criterion (Inferred from substantial equivalence claim)	Reported Device Performance (CLEARFIL TRI-S BOND PLUS Single Dose)
Biocompatibility	Confirmed to be biocompatible (based on ISO 10993 series and ISO 7405 evaluation for new ingredients).
Tensile Bond Strength	"Almost the same results" as the predicate device (CLEARFIL TRI-S BOND).
Fluoride Releasing Property	"Almost the same results" as the predicate device (CLEARFIL TRI-S BOND).
Overall Effectiveness and Performance	"As effective as and performs as good as or better than the predicate device."

Study Description:
The study was conducted to demonstrate substantial equivalence to predicate devices, specifically "CLEARFIL TRI-S BOND" for performance aspects. It involved:

Biocompatibility testing: For two new chemical ingredients, evaluation was done referring to ISO 10993 series and ISO 7405.
Performance testing: Tensile bond strength test and Fluoride releasing property were performed.

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

The document does not explicitly state the sample sizes used for the tensile bond strength test, fluoride releasing property test, or the biocompatibility evaluations.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied to be laboratory testing for performance characteristics and ingredient evaluations rather than patient data.

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

This information is not applicable in the context of this 510(k) summary. The "ground truth" for chemical composition, biocompatibility, and physical properties (like bond strength) is established through standardized laboratory tests and material science principles, not through expert consensus on patient data.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for clinical image interpretation or diagnostic studies involving human readers, which is not the nature of the tests described for this dental bonding agent.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study involves human readers interpreting cases with and without AI assistance and is relevant for diagnostic imaging devices. The CLEARFIL TRI-S BOND PLUS Single Dose is a material (dental bonding agent), not a diagnostic or AI-powered device.

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

No, a standalone performance study in the context of an algorithm or AI was not done. This device is a material, not a software algorithm. The "standalone" performance refers to the device's inherent material properties as tested in the laboratory.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on objective laboratory measurements and material science standards.

Biocompatibility: Determined by adherence to ISO 10993 series and ISO 7405 standards for material safety.
Tensile Bond Strength: Measured quantitatively in a laboratory setting to evaluate the material's adhesive properties.
Fluoride Releasing Property: Measured quantitatively to assess this specific characteristic of the material.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning algorithms or AI models. This submission is for a medical device (dental bonding agent) that does not involve AI or machine learning. The studies described are for material characterization and performance comparison.

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

This information is not applicable as there is no "training set" for this device.

Summary

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510(k) Summary

OCT 1 4 2011

3-1. 510(k) owner (submitter)

3-1. 510(k) owner (submitter)
	1) Name	KURARAY MEDICAL INC.
	2) Address	1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
	3) Contact person	Michio TakigawaQuality Assurance Department
	4) Contact person in US	Kiyoyuki ArikawaKURARAY AMERICA INC.600 Lexington Avenue, 26th FloorNew York, NY 10022Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676Fax: (212)-867-3543
3-2. Name of Device
	1) Trade / Proprietary name	CLEARFIL TRI-S BOND PLUS Single Dose
	2) Classification name	Resin Tooth Bonding Agent(21 CFR section 872.3690. Product code: KLE)
	3) Common name	Dental bonding agent
3-3. Predicate device
	1) CLEARFIL TRI-S BOND	510(k) Number:Product Code:21 CFR Section:Applicant:	K042913KLE872.3690KURARAY MEDICAL INC.
	2) CLEARFIL DC BOND	510(k) Number:Product Code:21 CFR Section:Applicant:	K062382KLE872.3200KURARAY MEDICAL INC.
	3) PANAVIA F 2.0	510(k) Number:Product Code:21 CFR Section:Applicant:	K032455EMA872.3275KURARAY MEDICAL INC.
	4) CLEARFIL MAJESTY Flow	510(k) Number:Product Code:21 CFR Section:Applicant:	K063593EBF872.3690KURARAY MEDICAL INC.

・・

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3-4. Device Description

l ) The subject device is a single-component. light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. A single dose of it comes in a container with an applicator tip for fast, direct placement into the cavity.

3-5. Substantial Equivalence Discussion

l) Intended uses
The intended uses of the subject device were written up based on those of CLEARFIL TRI-S BOND and CLEARFIL DC BOND, the predicate devices.

Therefore, the intended uses of the subject device are substantially equivalent to those of the predicate devices.

2) Chemical ingredients / Safety

Except for 2 new chemical ingredients, all ingredients in the subject device have been used in the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.

And 2 new ingredients have been evaluated referring to ISO 10993 series and ISO 7405. As the result, it was confirmed that these substances were biocompatible. In conclusion, it can be said that the safety of the subject device is substantially equivalent to that of the predicate devices.

1. Technological characteristics /Effectiveness and Performance
  Since there have not been any international standards concerning performance of this type of device, 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.

Tensile bond strength test and Fluoride releasing property were performed to validate the substantial equivalence of the subject device with the predicate device in terms of effectiveness and performance for the intended uses. The test has 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.

3-6. Biocompatibility

And 2 new ingredients have been evaluated referring to ISO 10993 series and ISO 7405. As the result, it was confirmed that these substances were biocompatible. In conclusion, it was concluded that the biocompatibility of the subject device could be assured.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

OCT 1 4 2011

Kuraray Medical, Incorporated C/O Mr. Kiyoyuki Arikawa General Manger Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, NY 10022

Re: K111975

Trade/Device Name: Clearfil Tri-S Bond Plus Single Dose Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 6, 2011 Received: July 12, 2011

Dear Mr. Arikawa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class 111 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Arikawa

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htmg for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

hr for

Anthony D. Watson, B.S.. M.S.. M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: CLEARFIL TRI-S BOND PLUS Single Dose

Indications for Use:

[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 non-precious metal posts
[6] Post cementation and core build·ups using dual·cured composite resin CLEARFIL DC CORE PLUS
[7] Core build-ups using light-cured composite resin

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use N/A
(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Kuaiep

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.