GLUMA ONE BOND

• K Number: K990143
• Device Name: GLUMA ONE BOND
• Manufacturer: HERAEUS KULZER, INC.
• Date Cleared: 1999-02-25 ( 37 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: DE
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

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.

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.