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510(k) Data Aggregation
(85 days)
Opal® Bond™ Flow is a light viscosity, light cure bonding adhesive used for bonding to etched enamel and is recommended for appliances, permanent retainers, bondable bite turbos/ramps or similar applications.
Opal® Bond™ Flow is a light cure adhesive designed for bonding brackets other bondable appliances to etched enamel.
The provided text describes a 510(k) submission for "Opal® Bond™ Flow," a light cure bracket adhesive. The submission aims to demonstrate substantial equivalence to predicate devices, focusing on performance characteristics through in-house testing and comparisons.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The text doesn't explicitly state "acceptance criteria" with numerical thresholds for each test. Instead, it describes desired outcomes relative to competitors for each functional test performed. The reported device performance is described as "as well or better than the predicate devices currently on the market."
| Function | Acceptance Criteria (Desired Outcome described) | Reported Device Performance |
|---|---|---|
| Shear Peel | Higher adhesion onto brackets compared to competitors (acceptable and preferred). | Performs as well or better than predicate devices. |
| Flexural Strength | Higher number than competitors (good). Modulus side comparable to most competitors. | Performs as well or better than predicate devices. |
| Hardness | Within competitors' range. | Performs as well or better than predicate devices. |
| Shear Bond (with bracket) | Highest value compared to competitors acceptable. | Performs as well or better than predicate devices. |
| Compressives | High numbers compared to competitors acceptable. | Performs as well or better than predicate devices. |
| Metal Shear | Both measures high or higher than competitors. | Performs as well or better than predicate devices. |
| Depth of Cure | At the high end of competitors. | Performs as well or better than predicate devices. |
| Tensile Pull | (No specific criteria described, only that it measures force to pull off a bracket.) | Performs as well or better than predicate devices. |
| Ambient Light Sensitivity | Low times for working and cure time. | Performs as well or better than predicate devices. |
| Sorption | Low readings. | Performs as well or better than predicate devices. |
| Stain Testing | Low score (1 being lowest, less staining). | Performs as well or better than predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact sample sizes used for each of the bench tests (Shear Peel, Flexural Strength, etc.). It only states that these tests were "conducted during the R & D phase on Opal® Bond MV and compared to 3M Unitek's Transbond and Transbond LV (K073697) and Reliance's Flow-Tain LV (K083051)."
- Data Provenance: The data is from "in-house testing" conducted during the R&D phase by Opal Orthodontics. It is retrospective for the purpose of this 510(k) submission, as it was performed prior to the submission. The country of origin of the data is implicitly the USA, where Opal Orthodontics is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There were no human experts used to establish "ground truth" for the performance tests. The "ground truth" for these physical and chemical property tests is derived directly from the laboratory measurements and comparisons to predicate devices, following established scientific and industrial standards for materials testing in dentistry.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements of material properties, not subjective assessments requiring expert adjudication.
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
Not applicable. This device is a dental adhesive, not an imaging or diagnostic AI-assisted device. Therefore, no MRMC study involving human readers and AI assistance was conducted or is relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or software. It is a physical dental adhesive.
7. The Type of Ground Truth Used
For the bench tests, the "ground truth" is based on objective physical and chemical property measurements and comparative performance against legally marketed predicate devices, as well as adherence to established industry standards for testing such materials. There is no mention of pathology, outcomes data, or expert consensus in establishing the ground truth for these specific material performance tests.
8. The Sample Size for the Training Set
Not applicable. This device is a physical product, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a physical product.
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