to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.
to seal dentinal tubules
to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth
to promote bonds between incremental layers of composite resins when building a composite restoration
to bond composite resins repairs to ceramics and metals

Device Description

Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. It consists of surface conditioners, primers, an adhesive resin, initiators and accessories for applying the components to tooth surfaces. After tooth conditioning, a primer is applied, and an adhesive resin overlayer is subsequently placed on the surface to interact with restorative materials. Other primers are used for surface reactions with indirect restorative materials.

AI/ML Overview

The provided text describes a 510(k) submission for a dental bonding system called "Adhere" (K99283Y). It focuses on establishing substantial equivalence to predicate devices based on performance and component use. However, the document does not explicitly detail specific quantitative acceptance criteria or a dedicated study design/results that prove the device meets these criteria in the way typically expected for medical AI device submissions.

Instead, the submission for "Adhere" relies on the established performance of its predicate devices and the general understanding that its components and intended use align with these devices. This type of submission (from 1999) predates the rigorous requirements for AI/ML-based medical devices that necessitate detailed performance metrics, ground truth establishment, and statistical studies.

Based on the provided information, I can extract and infer some aspects, but it's crucial to understand that many requested details (especially those related to AI/ML device studies like sample sizes, expert qualifications, adjudication, MRMC, and training sets) are not present in this 1999 510(k) submission for a dental bonding agent.

Here's an attempt to answer based on the provided text, highlighting what is available and what is not:

Acceptance Criteria and Device Performance Study (Adhere - K99283Y)

This 510(k) summary for Adhere, a dental bonding system, primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a standalone study with explicit quantitative acceptance criteria for device performance as would be expected for an AI/ML device. The "performance" mentioned refers to its ability to bond restorative materials and reduce tooth sensitivity, consistent with its intended use and the function of predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a dental bonding agent from 1999, the "acceptance criteria" are implied by the performance of predicate devices in achieving strong bonds and reducing sensitivity. Explicit quantitative metrics and reported performance values are not provided in this summary. Instead, the claim is that Adhere's performance is substantially equivalent to these devices.

Acceptance Criterion (Implied)	Reported Device Performance (Implied)
Ability to bond restorative materials to enamel and dentin	Substantially equivalent to predicate devices (Optibond, All Bond 2, One Step, Silane Bond Enhancer) in achieving strong bonds for composites, compomers, amalgam, ceramic veneers, and ceramic inlays.
Ability to seal dentinal tubules	Substantially equivalent to predicate devices in sealing dentin.
Ability to reduce tooth sensitivity	Substantially equivalent to predicate devices in reducing sensitivity in non-bacterial mediated cervical lesions.
Promotion of composite bonds to ceramics and metals	Substantially equivalent to predicate devices in promoting bonds.

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

Not applicable/Not provided. This information is typically relevant for quantitative performance studies, especially for AI/ML devices. For this dental bonding material, the assessment of substantial equivalence would have likely involved chemical composition analysis, mechanical bond strength testing (pre-clinical), and potentially some clinical observations, but the details of such "test sets" for these specific criteria are not in the summarized document.

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

Not applicable/Not provided. The concept of "ground truth established by experts" in this context is not directly addressed. The performance claims are based on the known science of dental adhesives and comparison to existing products.

4. Adjudication Method for the Test Set

Not applicable/Not provided. This is a concept related to clinical trials or performance studies involving human assessment, which is not detailed here for this type of device.

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

No. This type of study (MRMC) is generally performed for diagnostic imaging devices or AI-assisted diagnostic tools where human readers interpret medical images. Adhere is a dental bonding agent, and such a study would not be relevant.

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

No. Adhere is a physical dental material, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.

7. The Type of Ground Truth Used

The "ground truth" for a dental bonding agent is typically established through:

Mechanical Testing: Bond strength (shear, tensile) measured in laboratory settings using standardized protocols on extracted teeth or simulated tooth structures.
Clinical Efficacy/Safety Data: While not detailed here, prior clinical use of similar materials and possibly clinical observations from trials (not elaborated in the summary) would form the basis for "ground truth" regarding its effectiveness in living patients.
Chemical/Material Analysis: Demonstrating the chemical properties and components align with established, safe, and effective materials.

Given the 510(k) nature, the "ground truth" largely refers to the accepted performance standards and outcomes observed with the predicate devices.

8. The Sample Size for the Training Set

Not applicable/Not provided. As this is a traditional medical device (dental material) and not an AI/ML device, there is no "training set" in the computational sense.

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

Not applicable/Not provided. See the explanation for point 8.

Summary

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K99283Y

NOV 1 5 1999

5612 Glenwood Road • Bethesda, MD • 20817 • tel 301.652.8827 • www.biomatsciences.com

510(k) Summary

BioMat Sciences, Inc. 1. Submitter 5612 Glenwood Road Bethesda, MD 20817 Tel 301 652-3327 Fax 301 652-8827 Dr. Ivan Stangel (contact person) August 5, 1999 (date of preparation)
1. Device Name Trade name - Adhere Common name - Tooth bonding system Classification name - agent, tooth bonding, resin (per CFR 872.3200)
1. Legally marketed device for which substantial equivalence is being claimed

Optibond (Kerr, 510k #K923546) All Bond 2 (Bisco, 510k #K910860) One Step (Bisco, 510k #K945604) Silane Bond Enhancer (Pulpdent Corporation 510k #896659)

4. Device Description

5. Intended Use of the Device

Adhere is used to bond restorative materials to enamel and dentin. The materials include composites, compomers, amalgam, ceramic veneers and ceramic inlays. In addition, Adhere is used to seal dentin, and reduce tooth sensitivity in non-bacterial mediated cervical lesions of teeth. Adhere is also used to promote composite bonds to ceramics and metals.

1. Technological Characteristics of Present Device Compared to Predicate Device Adhere is substantially equivalent to other legally marketed predicate dental devices. Substantial equivalence is based on performance and the use of components found in other legally marketed tooth bonding agents.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, with three human profiles incorporated into the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 5 1999

Mr. Ivan Stangel, D.M.D., F.A.D.M., F.I.C.D. President & Director of Research BioMat Sciences 5612 Glenwood Road Bethesda, MD 20817

K992838 Re : Adhere Conditioner, Adhere Primer, Adhere LC Trade Name: Adhesive, ADH Requlatory Class: II Product Code: KLE Dated: August 15, 1999 August 23, 1999 Received:

Dear Mr. Stangel:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Page 2 - Mr. Stangel

obligation you might have under sections 531 through 542 of obligation you magne the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compriance at (30 advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note one regulation entitled, "Misbranding by reference to
the regulation entification" (21 CFR 807.97). Other gener Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. Statement of Indications for Use:

to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.
to seal dentinal tubules
to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth
to promote bonds between incremental layers of composite resins when building a composite restoration
to bond composite resins repairs to ceramics and metals

Prescription Usa Usa (Per 21 CFR 801.109)

Supam Runore

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.