(59 days)
- All classes of fillings (according to Black) with light-curing composite or compomer filling materials
- Repair of composite resin or compomer fillings
- Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
- Protective varnish for glass ionomer fillings
EZ Bond Universal, manufactured by Meta Biomed, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200). EZ Bond universal is a single-bottle solution. Depending on the indication, the adhesive can be used for direct and indirect restorations with light cured composites in a "self-etching" procedure, "total-etching" procedure or" selective-etching" procedure. EZ Bond Universal is methacrylate-based restoratives, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (glass ceramics, alumina and zirconia) without an extra primer step.
The provided text describes the regulatory clearance of a dental bonding agent and includes a section on non-clinical testing. However, it does not contain information about a study involving AI assistance, human readers, or image analysis, which the requested questions (2-9 and parts of 1) are primarily focused on. The device is a "Resin Tooth Bonding Agent," not a device that involves AI algorithms or image interpretation by experts.
Therefore, I can only address the acceptance criteria and performance data available for this specific type of dental product based on the provided document.
Acceptance Criteria and Reported Device Performance
1. A table of acceptance criteria and the reported device performance
The document provides the reported performance values for the subject device and the predicate device against certain technical characteristics. It states that the subject device was tested to evaluate its safety and effectiveness according to ISO standards. While specific numerical acceptance criteria (e.g., "must be > X MPa") are not explicitly listed in a separate column, the values are compared to the predicate device and implicitly against relevant ISO standards.
| Characteristic | Acceptance Criteria (Implicit from ISO/Predicate) | Reported Subject Device Performance | Reported Predicate Device Performance (for comparison) |
|---|---|---|---|
| Biocompatibility | Compliant with ISO 10993 series | Achieved compliance | (Not explicitly stated for predicate, assumed compliant as legally marketed) |
| Film thickness | Within acceptable range (ISO 4049:2019) | 4 µm | 10.6 µm |
| Sensitivity to Ambient Light | Material remains physically homogeneous | Material remained physically homogeneous | Material remained physically homogeneous |
| Bond strength (Dentine) | Within acceptable range (ISO 29022:2013, ISO/TC 11405:2015) | 23.2 Mpa | 35.8 Mpa |
| Bond strength (Enamel) | Within acceptable range (ISO 29022:2013, ISO/TC 11405:2015) | 23.7 Mpa | 26.4 Mpa |
| Solubility | Within the range of ISO 4049:2009 | (Explicitly stated as "within the range") | (Not explicitly stated, assumed compliant) |
| Shelf Life | 2 Years (as per predicate and ISO standards) | 2 Years | 2 Years |
Regarding the other requested information (2-9):
The provided text does not contain any information related to:
- 2. Sample size used for the test set and data provenance: No information on sample sizes for the performance tests (e.g., number of dentin/enamel samples). No geographical or temporal provenance for the test data.
- 3. Number of experts used to establish the ground truth and their qualifications: Not applicable for this type of product/testing. Ground truth is based on physical material properties and ISO standard tests, not expert consensus on interpretations.
- 4. Adjudication method for the test set: Not applicable for this type of product/testing.
- 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This type of study involves human readers interpreting cases, often with AI assistance. This is not relevant to a dental bonding agent.
- 6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
- 7. The type of ground truth used: The ground truth for this device's performance is based on physical and chemical property measurements conducted according to established international standards (ISO), not expert consensus, pathology, or outcomes data in the context of interpretation.
- 8. The sample size for the training set: Not applicable; this device does not use machine learning or AI with training sets.
- 9. How the ground truth for the training set was established: Not applicable; this device does not use machine learning or AI.
In summary, the document details non-clinical testing for a dental bonding agent, focusing on physical and chemical performance characteristics against ISO standards and comparison to a predicate device. It does not involve any imaging, AI, or human interpretation studies.
§ 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.