GLUMA ONE BOND by HERAEUS KULZER, INC.

Serves as a desensitizer/preventative in dentin hypersensitivity conditions by Serves as a decomorialized proventual tubules which effectively blocks the fluid flow in the tubules that cause sensitivity.

Device Description

GLUMA ONE BOND is a one bottle adhesive, designed to bond resinous restorative materials to dental hard tissue. The product is a light curing monomer mixture dissolved in acetone which, following conditioning with phosphoric acid, is applied to enamel and dentin prior to co- polymerization with the restorative. The composition of GLUMA ONE BOND is based on three monomers which individually have been used in marketed dental products for decades. The hydrophilic hydroxyethylmethacrylate (HEMA) is essential for perfect wetting of and penetration into the conditioned tooth structure. Similarly, 4-MET(A) has hydrophilic and moieties for wetting and polymerization, whereas the urethane di-methacrylate monomer is responsible for formation of a cross-linked polymer network. The organic solvent acetone has the function of a carrier for the monomers while being an effective water chaser at the same time.

AI/ML Overview

The provided text describes a dental adhesive product called GLUMA ONE BOND, but it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria as would be expected for a diagnostic AI/ML device.

The document is a 510(k) submission for a medical device (a dental bonding agent) and an FDA clearance letter. It describes the product's composition, intended use, and briefly mentions:

"Thorough in-vitro investigation has proven that the GLUMA ONE BOND performs better than or at least as good as the leading resinous bonding systems available in the market."
"The results of a short-term clinical observation done by eight dentists under regular office conditions, on some more than 300 restorations bonded with GLUMA ONE BOND confirms that the product is easy to use, safe, and effective."

This information is insufficient to answer the detailed questions regarding acceptance criteria and study design for an AI/ML device. The request specifically asks about "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML device, referencing concepts like test sets, ground truth, experts, and comparative effectiveness studies, which are not applicable to the GLUMA ONE BOND description.

Therefore, for the requested information:

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

Cannot be provided. The text does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC) or detailed performance metrics relevant to an AI/ML device. It only makes general statements about performing "better than or at least as good as" leading systems and being "easy to use, safe, and effective."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Test set sample size: "some more than 300 restorations" were observed clinically. This refers to a clinical observation, not a specific test set for an AI/ML algorithm.
Data provenance: Not specified. It was "under regular office conditions" but no country or retrospective/prospective nature is detailed.

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):

Number of experts: "eight dentists" conducted the clinical observation.
Qualifications: "dentists" is the only qualification mentioned. Specific experience or specialization is not provided.
Ground truth establishment: Not applicable in the context of an AI/ML device's test set. The clinical observation focused on user experience (easy to use) and general safety/effectiveness of bonding, not on establishing a diagnostic ground truth.

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

Cannot be provided. Adjudication methods are relevant for establishing ground truth in diagnostic studies, which is not described here.

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. An MRMC comparative effectiveness study is not described. The product is a dental adhesive, not an AI/ML diagnostic tool.

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

No. This question is not applicable as the product is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the clinical observation, the "ground truth" was likely subjective assessment by the dentists regarding ease of use, safety, and effectiveness of the bonding performance, rather than a formal, objective ground truth like pathology for a diagnostic device. For the in-vitro studies, the "ground truth" would be objective measurements of bond strength and durability in a lab setting, but specifics are not given.

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.

Summary

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eraeus Kulzer, Inc. South Bend, IN. 46614 GLUMA ONE BOND 510(K)

Statement of Safety and Effectiveness

The composition of GLUMA ONE BOND is based on three monomers which individually have been used in marketed dental products for decades. The hydrophilic hydroxyethylmethacrylate (HEMA) is essential for perfect wetting of and penetration into the conditioned tooth structure. Similarly, 4-MET(A) has hydrophilic and moieties for wetting and polymerization, whereas the urethane di-methacrylate monomer is responsible for formation of a cross-linked polymer network. The organic solvent acetone has the function of a carrier for the monomers while being an effective water chaser at the same time.

The application procedure is very easy. The solution is applied in small amounts to the conditioned moist tooth surface with two to three consecutive strokes, the water acetone is eliminated by a gentle air blast and finally, the resin is light cured for 20 seconds. Thorough in-vitro investigation has proven that the GLUMA ONE BOND performs better than or at least as good as the leading resinous bonding systems available in the market. GLUMA ONE BOND is also proven to bond to non-precious dental alloys, such as CoCrbased casting alloy and amalgam.

The results of a short-term clinical observation done by eight dentists under regular office conditions, on some more than 300 restorations bonded with GLUMA ONE BOND confirms that the product is easy to use, safe, and effective. Based on this evidence and the very promising in vitro data, GLUMA ONE BOND is recommended as an effective enamel/dentin adhesive when used in accordance with the instructions for use.

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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 consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 1999

Ms. Cheryl V. Zimmerman Heraeus Kulzer, Incorporated Dental Products 4315 South Lafayette Boulevard South Bend, Indiana 46614-2517

Re: ' K990143 Gluma One Bond Trade Name: Regulatory Class: II Product Code: KLE । ਰੇ ਰੇ ਰੇ Dated: January 12, January 19, 1999 Received:

Dear Ms. Zimmerman:

We have reviewed your Section 510(k) notification of intent to we have reviewed forferenced above and we have determined the market the device forly equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the cholorstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment according in accordance with the devices chac nave Federal Food, Drug, and Cosmetic Act (Act). 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 provisions of the ing 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 (Premarket Approval), it may be subject to such additional controls. Existing major be babject to becting 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: chis response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Ms. Zimmerman

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally Finding of Subbeancear Cycreaults in a classification for your mavice 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 807.97). Other qeneral 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/dsma/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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Heraeus Kulzer, Inc. South Bend, IN. 46614 GLUMA ONE BOND 510(K)

く

K990143

Page 1

510(k) Number (if Known): K974,300 12974390

Device Name: Gluma One Bond

Indications For Use:

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

Concurrence of CDRH, Office of Device evaluation (ODE)

Susan Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Kga

Prescription Use
(Per 21 CFR 801.109)

· Over-The-Counter Use _

(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.