OptiBond FL is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.

Device Description

The device is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays.

AI/ML Overview

This document is a 510(k) summary for a dental resin bonding agent, not a study report for a digital health device or AI/ML algorithm. Therefore, it does not contain the information required to answer your specific questions regarding acceptance criteria and a study proving device performance in the context of an AI/ML device.

Here's why and what information is available:

Device Type: The device described, OptiBond FL, is a Resin Tooth Bonding Agent (a physical dental material), not a digital health device or an AI/ML algorithm.
Approval Type: This is a 510(k) premarket notification, which establishes substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical trial or algorithm validation study in the way an AI/ML device would.
Focus of Document: The document focuses on the device description, intended use, and substantial equivalence to a predicate device (OptiBond Solo Plus 2). It confirms that the FDA reviewed the submission and found the device substantially equivalent.

Therefore, I cannot extract the following information because it is not present in the provided text:

A table of acceptance criteria and the reported device performance.
Sample size used for the test set and the data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc).
The sample size for the training set.
How the ground truth for the training set was established.

This document is a regulatory approval notice for a medical device, not a performance study report for an AI/ML system.

Summary

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JUL 2 2003

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SYBRON DENTAL SPECIALTIES

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-74 84 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: May 2003

Device Name:

Trade Name OptiBond FL .
. Common Name - Resin Tooth Bonding Agent
Classification Name Resin Tooth Bonding Agent, per 21 CFR § 872.3200 .

Devices for Which Substantial Equivalence is Claimed:

Kerr Corporation, OptiBond Solo Plus 2 .

Device Description:

Intended Use of the Device:

The intended use of OptiBond FL is for bonding composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and for bonding veneers, onlays, and inlays.

Substantial Equivalence:

OptiBond FL is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 2003 JUL

2003

Kerr Dental Materials Center C/O Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 1717 W. Collins Avenue Orange, California 92867

Re: K031444

Trade/Device Name: Optibond™ FL Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: May 05, 2003 Received: May 08, 2003

Dear Ms. Boswell:

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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Page 2 - Ms. Colleen Boswell

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 (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.

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html

Sincerely yours

Susan Runne

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Section I - Indications for Use

Ver/ 3 - 4/24/96 Applicant: Kerr Dental Material Center 510(k) Number (if known): Device Name: OptiBond FL Indications For Use: OptiBond FL is a multi-purpose bonding agent designed to be used in the following situations: composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, bonding composite core build-up materials, and veneers, onlays, and inlays. Division of Anesthesiology, General Ho ction Control. Dental De (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional Format 1-2-96)

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.