(89 days)
- All direct restorations
- All indirect restorations
- Desensitizing/sealing of tooth
- Intra-oral repairs
Dia-X Bond Universal is a universal adhesive capable of total, self, and selective etching as it consists of a single bottle of etching, primer, and adhesive resin. It can be used for both direct bonding of restorations.
The provided text describes a 510(k) premarket notification for a dental bonding agent named "Dia-X Bond Universal." The application focuses on demonstrating substantial equivalence to a predicate device, DIAPLUS Universal, rather than conducting a full clinical study with specific acceptance criteria in the typical sense of a medical diagnostic device.
Therefore, the information requested about acceptance criteria, study design for proving they are met, sample sizes, expert involvement, and ground truth establishment, does not directly apply in the same way as it would for a medical diagnostic device with performance metrics like sensitivity, specificity, or FROC scores.
The "acceptance criteria" here are more about demonstrating that the new device meets established standards and is functionally similar and safe compared to an already approved device. The "study" is a collection of non-clinical tests to show this equivalence.
Here's an attempt to answer your questions based on the provided document, interpreting "acceptance criteria" as compliance with relevant standards and "study" as the non-clinical performance data and biocompatibility tests:
1. A table of acceptance criteria and the reported device performance
For this premarket notification, the acceptance criteria are primarily defined by adherence to harmonized international standards for dental materials and demonstration of comparable physical properties and biocompatibility to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from Standards & Comparat.) | Reported Device Performance (Summary from Non-Clinical Data) |
|---|---|---|
| Material Standards Compliance | Conformance to ISO 4049 (Polymer-based restorative materials) | Conformed |
| Conformance to ISO 29022 (Adhesive - Notched-edge shear bond strength) | Conformed | |
| Biocompatibility Standards Compliance | Conformance to ISO 7405 (Evaluation of Biocompatibility of Medical Devices in Dentistry) | Conformed |
| Conformance to ISO 10993-1, 3, 5, 10, 11 (Biological evaluation) | Most tests were "Compatible," with an explanation for "Not Compatible" in cytotoxicity. | |
| Physical Properties | Similar Film Thickness to predicate | Performed (Result not explicitly quantified as 'value met') |
| Similar Sensitivity to Light to predicate | Performed (Result not explicitly quantified as 'value met') | |
| Similar Shear Bond Strength to predicate | Performed (Result not explicitly quantified as 'value met') | |
| Similar Occlusion of Dental Tubules to predicate | Performed (Result not explicitly quantified as 'value met') | |
| Chemical Composition | Same composition as predicate device | Equivalent (As per comparison table) |
| Indication for Use | Same indications as predicate device | Equivalent (As per comparison table) |
| Principle of Operation | Same principle of operation as predicate device | Equivalent (As per comparison table) |
Note on "Cytotoxicity Study": The table states "Not Compatible BSE" for the Cytotoxicity Study but provides an explanation: "Among the components of this product, 10-MDP is an acidic monomer, and depending on the acidity, it is a substance that causes cytotoxicity according to the principle of action of this product, so cytotoxicity test setting the test item is meaningless." This essentially argues that for this specific type of dental adhesive, some level of cytotoxicity is inherent to its mechanism of action and is considered acceptable within the context of its intended use and formulation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes for the individual non-clinical performance tests (Film Thickness, Shear Bonding Strength, Sensitivity to Ambient Light, Occlusion of dentinal tubules) or for the biocompatibility tests beyond listing the tests themselves.
The data provenance is implicit: the tests were conducted by Diadent Group International, a company based in South Korea. The tests are non-clinical, likely laboratory-based, and would be considered prospective in the sense that they were performed specifically for this submission, but not in the clinical trial sense.
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)
This question is not applicable to this type of device submission. There was no "test set" in the context of expert review for diagnostic accuracy, nor was there a concept of "ground truth" established by experts in this manner. The studies conducted were laboratory-based physical and biological tests against established standards, not expert-adjudicated clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. There was no expert adjudication process for a test set, as the evaluation relied on laboratory measurements and adherence to international standards.
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
This question is not applicable. The device is a resin tooth bonding agent, not an AI-powered diagnostic tool. Therefore, no MRMC study or evaluation of human reader improvement with AI assistance was conducted or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context refers to the established scientific and technical standards for dental materials, specifically:
- ISO 4049: Dentistry -- Polymer-based restorative materials
- ISO 29022: Dentistry -- Adhesive -- Notched-edge shear bond strength test
- ISO 7405: Dentistry - Evaluation of Biocompatibility of Medical Devices Used In Dentistry
- ISO 10993 series: Biological evaluation of medical devices (Parts 1, 3, 5, 10, 11)
The "ground truth" for the comparative physical properties was the performance of the legally marketed predicate device (DIAPLUS Universal), implying that its performance established an acceptable benchmark.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a dental bonding agent, as it is a material, not a machine learning model.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
§ 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.