(199 days)
As a Universal Self-Etching Adhesive Bonding System, BONDEASIER SE SYSTEM is indicated to be used as a universal dental adhesive to etch, prime and bond to a tooth structure and meth(acrylic) dental composite.
The subject device is a combination of chemical and light-cured self-priming adhesive in a solvent formulation. Bondeasier SE device is not technique sensitive. It requires painting the tooth surface followed by blowing with air to remove the solvent and placing 1-2 layers of 2-3mm of filled light cure Bondeasier SE Adhesive Resin. Lastly, the final curing of each layer of Bondeasier Adhesive Resin is done with a dental curing light.
The information provided shows that the device, American Dental Products BONDEASIER SE SYSTEM, is a dental adhesive. The study submitted for its acceptance is a "side by side bonding test" comparing it to a predicate device, Bisco's "One step". This is not a study typically assessed using acceptance criteria like sensitivity, specificity, or AUC, as it's a comparison of material properties rather than diagnostic or prognostic performance. Therefore, many of the requested fields are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bonding to tooth structure | Proves to bond to the tooth structure. |
| Shear bond strength (quantitative comparison to predicate) | Results of the shear bond strength are reported in tabular form and in detail within the application, proving substantial equivalence to the predicate. |
Note: The specific numerical acceptance criteria for shear bond strength are not provided in the summary, nor are the specific numerical results. The document states that the results are reported "in tabular form and in details into this application" suggesting they were provided to the FDA, but not included in this summary document. The acceptance criterion is implicit: the device's shear bond strength should be substantially equivalent to the predicate device, Bisco's "One step".
Study Details
1. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided text for the bonding tests.
- Data Provenance: The study was conducted by American Dental Products Inc. There is no information about the country of origin of the data (e.g., teeth used) or whether it was retrospective or prospective.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of study does not involve human expert interpretation of images or other data to establish ground truth. The "ground truth" here is the physical measurement of bond strength on tooth structures.
3. Adjudication method for the test set:
- Not Applicable. This is not a study where human interpretation is being adjudicated.
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. This is not an MRMC study and does not involve AI assistance.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a comparison of two dental bonding systems, not an algorithm.
6. The type of ground truth used:
- Physical Measurement / Mechanical Test Results: The ground truth is established through physical measurements of bond strength on tooth structures, comparing the device's performance to an already legally marketed predicate device.
7. The sample size for the training set:
- Not Applicable. There is no mention of a "training set" as this is a non-clinical material performance study, not an AI or machine learning model.
8. How the ground truth for the training set was established:
- Not Applicable. See above.
§ 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.