(164 days)
Direct Applications:
- Light cured composite restorations
- Light cured compomers
- Cavity sealing prior to placement of indirect restorations
- Composite repair of porcelain and hybrid ceramic restorations
- Sealing exposed root surfaces which are causing hypersensitivity
- Core build ups using light cure/dual cure composites
- Protective varnish for glass ionomer (GI) filling
Indirect Applications:
- Cementation indirect restorations
Zipbond is a single-component, (meth)acrylate-based material which functions as a combined etch-and-rinse (total-etch), self-etch and selective-etch dental adhesive. It offers an adhesive application technique for both direct indications and bonds to enamel, dentin, composites, cements. When used with a LED light curing device, Zipbond can be used with self-cure, dual-cure and light cure resin cements, composites and core-build up materials. Zipbond provides the operator with three choices of enamel and dentin pre-treatment: Self-etch mode: no phosphoric acid etching required prior to application, Selective-etch mode: selective phosphoric acid etching to enamel, Total-etch mode: phosphoric acid etching of both enamel and dentin.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Zipbond™ device:
It's important to note that the provided documents are a 510(k) premarket notification, which aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically focuses on comparing the new device against the predicate, rather than establishing strict acceptance criteria for a novel technology or conducting extensive standalone performance studies with human readers, as might be done for an AI/software as a medical device (SaMD).
Therefore, some of the requested information (like MRMC studies, specific effect sizes of AI with human readers, or detailed ground truth establishment for large training sets) is not applicable or not explicitly detailed in this type of submission for a dental bonding agent.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating equivalence to the predicate device and meeting relevant ISO standards.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (Zipbond™) |
|---|---|
| Equivalence to Predicate Device (Scotchbond Universal Adhesive K110302) | Demonstrated substantial equivalence in intended use, fundamental technology, and similar indications for use. |
| pH measurement (according to internal method) | Satisfactorily met the requirements. (Specific value not provided in this document) |
| Shear bond strength on enamel and dentin (ISO 29022:2013) | Performed similarly to the predicate device. Satisfactorily met the requirements. (Specific bond strength values/comparison not provided in this document, but implied to be equivalent or non-inferior to the predicate.) |
| Biocompatibility (ISO 10993-1 and ISO 7405) | Results of testing and biological risk assessment support substantial equivalence. |
| Physical properties and performance | Satisfactorily met requirements. (Appearance, pH, shear bond strength on various substrates explicitly mentioned) |
Study Details
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for each test (pH, shear bond strength, biocompatibility). These are typically laboratory bench tests, where sample sizes are determined by statistical requirements for each specific test, but not usually presented in the 510(k) summary as "test set sample size" in the context of imaging or AI.
- Data Provenance: The studies are in-vitro bench tests and biocompatibility tests conducted for the purpose of this 510(k) submission. They are prospective tests conducted by SDI Limited. The country of origin of the data would be Australia, where SDI Limited is based.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable in the context of this device and study. For a dental bonding agent, "ground truth" typically refers to physical measurements and standardized test results rather than expert interpretation of medical images or diagnostic outcomes. The "ground truth" for bond strength, pH, or biocompatibility is established by the methods themselves, not by expert consensus.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in expert-dependent tasks, such as reviewing medical images. For physical and biocompatibility testing of a dental material, the results are typically objectively measured outcomes of the standardized tests.
-
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. An MRMC comparative effectiveness study is not applicable for a dental bonding agent. This type of study is relevant for evaluating diagnostic imaging software where human readers (e.g., radiologists) use AI assistance to improve their performance. Zipbond™ is a physical dental material, not an AI-powered diagnostic tool.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. Zipbond™ is a chemical product (dental bonding agent), not an algorithm or a software device. The "standalone" performance here refers to its efficacy and safety as a product itself, which is what the non-clinical performance data (pH, shear bond strength, biocompatibility) aims to demonstrate.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the non-clinical performance data is based on objective, standardized laboratory measurements according to established ISO protocols (e.g., ISO 29022:2013 for shear bond strength, ISO 10993-1 and ISO 7405 for biocompatibility) and internal methods (e.g., pH measurement). It is not based on expert consensus, pathology, or outcomes data in the typical sense used for diagnostic devices.
-
The sample size for the training set:
- Not applicable. As Zipbond™ is a dental material and not an AI/machine learning model, there is no "training set" in the context of algorithm development.
-
How the ground truth for the training set was established:
- Not applicable. There is no "training set" for this 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.