This device 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 be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips).

AI/ML Overview

The provided document is a 510(k) premarket notification for a dental adhesive system, "Clearfil tri-S bond Single dose." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance in the way typically seen for AI/ML-based medical devices or diagnostic tools.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable as this document describes a traditional medical device (a resin tooth bonding agent) where performance is evaluated through material properties and mechanical tests rather than diagnostic accuracy or human-AI interaction.

Here's a breakdown of the available information:

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

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Safety: Same as predicate device (K042913)	The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913). The only difference is that it is filled in single dose tips. Therefore, it is considered the same in respect of safety.
Effectiveness: Substantially equivalent to predicate	Bond Strengths: Evaluated between bovine tooth and a composite resin, and between bovine dentin and core build-up composite resin. Marginal Sealing: Evaluated. Results showed the device is substantially equivalent to Clearfil tri-S bond (K042913) in effectiveness. Specific quantitative values are not provided in this summary.

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: Not specified quantitatively in this summary. The tests were performed "between bovine tooth and a composite resin" and "between bovine dentin and core build up composite resin."
Data Provenance: Not specified, but given the manufacturer is in Japan, it's likely the testing was conducted in Japan. The study is akin to in vitro or ex vivo testing, not a clinical study on human subjects.

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. This is a material testing study, not a diagnostic study requiring expert ground truth for interpretation. Performance is assessed through physical and mechanical properties.

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

Not Applicable. Adjudication methods are relevant for clinical or diagnostic studies involving human interpretation. This summary describes 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/ML device, nor is it a diagnostic tool that involves human readers or AI assistance.

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)

Direct measurement of material properties: "Bond strengths" and "marginal sealing" are direct measurements or observations of the material's physical performance, not a "ground truth" established by human experts in a diagnostic context. The "truth" is based on the quantifiable physical properties of the materials and their interaction.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set.

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

Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.

Summary of Study:

The study described is a comparison of the "Clearfil tri-S bond Single dose" device to its predicate device, "Clearfil tri-S bond (K042913)," focusing on material properties and performance. The primary findings are:

Safety: The device is considered safe because its ingredients and composition are identical to the predicate device, with the only difference being the single-dose packaging.
Effectiveness: The device demonstrates substantial equivalence to the predicate in effectiveness, as evidenced by comparable "bond strengths" (between bovine tooth/composite and bovine dentin/core build-up) and "marginal sealing."

The 510(k) summary asserts substantial equivalence based on these comparisons, indicating that the new device performs at least as well as the legally marketed predicate device for its intended uses. No quantitative results for bond strength or sealing are provided in this summary, only the statement of substantial equivalence.

Summary

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[Clearfil tri-S bond Single dose, Kuraray Medical Inc.] AUG 9 - 2005

K051796

510(k) SUMMARY

Submitter

1) Name	KURARAY MEDICAL INC.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-8622, Japan
3) 1. Contact person	Masaya SasakiDental Material Division, Kuraray Medical Inc.
2. Contact person in U.S.A.	Satoshi YamaguchiKuraray America Inc.101 East 52nd Street, 26th FloorNew York, NY 10022Telephone: (212)-986-2230 (Ext.115)1-(800)-879-1676Facsimile: (212)-867-3543
4) Date	October XX, 2004

2. Name of Device

1) Proprietary Name	Clearfil tri-S bond Single dose
2) Classification Name	Resin tooth bonding agent (21CFR 872.3200)
3) Common/Usual Name	Resin-based dental adhesive system

Predicate device

The predicate device is as follow; a) Resin Tooth Bonding Agent 1. Clearfil tri-S bond

by Kuraray Medical Inc. (K042913)

4. Description for the premarket notification

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5. Statement of the intended use

The intended use of this device is as follows. It is the same as that of Clearfil triS bond (K042913) manufactured by Kuraray Medical Inc.

Indications for Use	Predicate device
1) Direct restorations using light-cured composite resin2) Cavity sealing as a pretreatment for indirectrestorations3) Treatment of exposed root surfaces4) Core build-ups using light- or dual-cured composite resin	Clearfil tri-S bond (K042913)

Statement of the safety and technological characteristics

6-1. Safty

The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips). Therefore this device is the same as the legally marketed predicate devices, Clearfil tri S bond, in respect of safety.

6-2. Technological characteristics

The bond strengths between bovine tooth and a composite resin, between bovine dentin and core build up composite resin and marginal sealing were evaluated in comparison with Clearfil tri-S bond . As to the result, this device is substantially equivalent to the legally marketed predicate devices, Clearfil tri-S bond, in effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center is an abstract emblem resembling an eagle or bird-like figure, composed of curved lines. The overall design is simple and monochromatic.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 9 - 2005

Kuraray Medical, Incorporated C/O Mr. Satoshi Yamaguchi Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022

Re: K051796

Trade/Device Name: Clearfil™ tri-S Bond Single Dose Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 01, 2005 Received: July 12, 2005

Dear Mr. Yamaguchi:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Susan Runne

Chiu S. Lin, PhD 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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510(k) Number (if known):

K051796

Device Name: Clearfil tri-S bond Single dose

Indications for Use

Clearfil tri-S bond Single dose is indicated for the following applications:

1. Direct restorations using light cured composite resin
1. Cavity sealing as a pretreatment for indirect restorations
1. Treatment of exposed root surfaces
1. Core build-ups using light- or dual-cured composite resin

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Prescription Use

Over-The-Counter Use

(Optional Format 1-2-96)

Susan Gunn

(Division Sign-Off)
Division of Anesthesiology, General Hosp

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.