(41 days)
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:
| Acceptance Criteria (Inferred) | Reported Device Performance (Gluma Comfort Bond) |
|---|---|
| Shear Bond Strength to Dentin: | |
| Comparable to Gluma One Bond, | |
| or comparable to "highly effective adhesive" | 25.1 ± 3.5 MPa |
| Shear Bond Strength to Enamel: | |
| Comparable to Gluma One Bond | 30.8 ± 6.1 MPa |
| Gap-free Fillings: | |
| High percentage of gap-free fillings | 5 out of 6 fillings were gap-free |
| Bonding to non-precious dental alloys: | |
| Demonstrated capability | Proven to bond to non-precious alloys (CoCr-based casting alloy and amalgam) |
Study Information
Based on the provided text, the information about the studies is limited.
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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.
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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.
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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.
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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.
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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.
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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.
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Sample Size for the Training Set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is not a machine learning or AI device.
§ 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.