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GLUMA® Comfort Bond is a light curing single component bonding agent use in restorative adhesive dentistry specifically developed for bonding resin-based filling materials (e.g. composites, compomers, Polyglas®) to hard dental tissues. Other indications include bonding of amalgam and laboratory-produced restorations. GLUMA® Comfort Bond permits priming and bonding to be carried out in single step.

Gluma Comfort Bonda is a one bottle adhesive, designed to bond resinous restarative matirlas to dental hard tissue. This product will provide the strength of 4-META and the ability to do a traditional 2-3 second drying after etching. The composition of Gluma Comfort 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 ethanol has the function of a carrier for the monomers while being an effective water chaser at the same time.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Gluma® Comfort Bond device:

The provided text is a 510(k) summary for the Gluma® Comfort Bond, which is a dental adhesive. It describes the device, its equivalence to other products, and presents some limited performance data.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as "acceptance criteria" in a formal table with pass/fail thresholds. Instead, the performance is presented through comparisons to a predecessor product (Gluma One Bond) and an independent evaluation organization (REALITY). The performance metrics provided are primarily shear bond strength and the number of gap-free fillings.

Here's a table summarizing the reported device performance, with inferred acceptance criteria based on the context of showing "excellent" performance and comparability to established products:

Study Information

Based on the provided text, the information about the studies is limited.

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: For the early shear bond strength test of Gluma Comfort Bond, the text states "five of the six fillings in the test were gap-free" and also provides bond strength results. This implies a very small sample size, likely 6 fillings for the gap-free assessment and potentially a similar small number of samples for the shear bond strength measurements (as results are presented as mean ± standard deviation, normally suggesting multiple measurements).
   • Data Provenance: Not specified, but given the context of a 510(k) submission from a US-based company, it's likely the testing was done internally or by a US-based lab. The mention of "Am J Dent 1996" suggests a study published in an American journal, which might imply the testing method is recognized within the US and potentially internationally. The data appears to be prospective as it describes a specific test performed on the new Gluma Comfort Bond formulation.

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

   • The text does not provide any information about experts establishing ground truth for the shear bond strength or gap-free nature of the fillings. These are objective physical measurements, not typically requiring expert consensus for ground truth establishment.
   • However, it does mention REALITY, an "independent testing" organization, giving Gluma One Bond four stars and calling it a "highly effective adhesive." The qualifications of REALITY's evaluators or the number of experts involved in their assessment are not detailed in this document.

3. Adjudication Method for the Test Set:

   • Not applicable as the evaluations are objective measurements (shear bond strength, gap-free assessment). There is no mention of subjective interpretation requiring adjudication.

4. 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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for AI or diagnostic imaging devices where human readers interpret cases, and its purpose is to measure the impact of an AI tool on human performance. Gluma Comfort Bond is a dental adhesive, not an AI-powered diagnostic device.

5. 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. The "standalone" performance here refers to the intrinsic physical properties of the adhesive itself.

6. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth for the performance metrics (shear bond strength, gap-free fillings) are objective physical measurements obtained through standardized laboratory tests.
   • For the bond to non-precious dental alloys, the "proven to bond" statement indicates qualitative experimental evidence.

7. Sample Size for the Training Set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable. As above, this is not a machine learning or AI device.

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Gluma Comfort Bond + Desensitizer is a light curing single component enamel/dentin adhesive for bonding of all current brands of resin composite restorative materials and compomers. It also provides adhesion to metals such as amalgam. Gluma Comfort Bond + Desensitizer combines primer and adhesive in a single bottle.

Serves as a desensitizer/preventative in dentin hypersensitivity conditions by means of sealing exposed dentinal tubules which effectively blocks the fluid flow in the tubules that cause sensitivity.

GLUMA COMFORT BOND + DESENSITIZER is a one bottle adhesive, designed to bond resinous restorative materials to dental hard tissue. It is an extension of the Gluma One Bond bonding system family. The product is a light curing monomer mixture dissolved in ethanol which, following conditioning with phosphoric acid, is applied to enamel and dentin prior to co- polymerization with the restorative. When compared with conventional bonding agents the main advantage of such simplified bond mediators is their reliability and ease of use in the dental office.

The composition of GLUMA COMFORT BOND + DESENSITIZER 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 ethanol has the function of a carrier for the monomers while being an effective water chaser at the same time. The addition of glutaraldehyde to the Gluma One Bond formula allows the dental practitioner to obtain the complete desensitizing and other effects of Gluma Desensitizer and the bonding of Gluma One Bond all from one bottle. The combination of glutaraldehyde and HEMA in Gluma Desensitizer penetrates the dentinal tubules to a depth of 200um, setting up multiple walls that block the flow of fluids in the tubules. This immediately eliminates dentinal tubule-caused hypersensitivity. In addition, it has been found that glutaraldehyde bonds covalently to the collagen fibers, aiding re-wetting and resulting in reduced marginal contraction gap.

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 and ethanol 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 COMFORT BOND + DESENSITIZER performs better than or at least as good as the leading resinous bonding systems available in the market. GLUMA COMFORT BOND + DESENSITIZER is also proven to bond to non-precious dental alloys, such as CoCr-based casting alloy and amalgam.

This document describes a 510(k) submission for a dental adhesive and desensitizer, not an AI-powered medical device. Therefore, the information requested about acceptance criteria, study details (sample sizes, ground truth, experts, MRMC studies, standalone performance), and training sets, which are typically relevant for AI/ML device evaluations, cannot be provided based on the given text.

The document focuses on demonstrating the substantial equivalence of the GLUMA COMFORT BOND + DESENSITIZER to existing legally marketed predicate devices. The "study" mentioned is primarily an in-vitro investigation of its performance and cytotoxicity data.

Here's how the provided information relates to your request, where applicable:

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

The document does not explicitly state formal acceptance criteria in a quantitative table format as might be expected for an AI device. Instead, the performance is described qualitatively by comparing it to predicate devices.

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 for Test Set: Not specified. The document mentions "Thorough in-vitro investigation," but no specific sample sizes for tests (e.g., number of teeth, bonding interfaces) are provided.
• Data Provenance: The document implies the investigations were conducted by the manufacturer, Heraeus Kulzer, Inc. The country of origin and whether the data was retrospective or prospective are not mentioned, though "in-vitro" strongly suggests a prospective, controlled laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This is not applicable as the device is a chemical dental product, not an imaging or diagnostic device that requires expert interpretation for ground truth. Performance evaluations would likely involve standardized laboratory testing and measurements (e.g., bond strength, depth of penetration).

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

• Not applicable for this type of device and its evaluation.

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-powered device, and no human reader studies are mentioned.

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

• Not applicable as this is not an algorithm or AI device. The device's "standalone" performance refers to its physical and chemical properties and effectiveness on its own.

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

• The "ground truth" for this device's performance would be established through objective laboratory measurements from the "in-vitro investigation." This would include:
  • Bond Strength: Measured in megapascals (MPa) for adhesion effectiveness to enamel, dentin, and alloys.
  • Penetration Depth: Measured in micrometers (µm) for the desensitizing agents into dentinal tubules.
  • Cytotoxicity: Standardized tests to assess the toxicity to cells.
  • Chemical Analysis: Verification of composition and stability.

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.

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