(90 days)
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- all direct restorations
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- all indirect restorations
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- intra-oral repairs (i.e. repair of any fixed dental prosthesis containing zirconia, alumina, metals, glass ceramics, tooth structure, and composites)
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- desensitizing/sealing of tooth structure
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- protective varnish for glass ionomer fillings
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- priming of enamel for orthodontic use
The Hi-Bond Universal is a light-curing dentin adhesive system composed of several resin monomers, inorganic fillers, polymerization-related initiators and accelerators, ethyl alcohol, and antioxidants. The Hi-Bond Universal is a light-curing type dental adhesive offering etching. priming, and bonding at once. The Hi-Bond Universal is packaged in a bottle made of polyethylene and polypropylene, and then packaged in a box.
The document provided is a 510(k) Premarket Notification from the FDA for a dental bonding agent named "Hi-Bond Universal." It primarily focuses on demonstrating substantial equivalence to a predicate device ("All-Bond Universal w/ BAC") rather than providing a detailed report of a study designed to meet specific acceptance criteria for a new AI/software device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for an AI/software device cannot be extracted from this document, as it pertains to a traditional medical device (dental adhesive) and not an AI-powered one.
However, I can provide the "Performance Data (Non-Clinical)" which lists the types of tests performed on the device to support its substantial equivalence. This section serves as the closest equivalent to "acceptance criteria and reported device performance" for this specific product.
1. A table of acceptance criteria and the reported device performance
The document lists the following non-clinical performance tests that were performed to support substantial equivalence. While it doesn't explicitly state "acceptance criteria" and "reported device performance" in a quantitative table for all tests, it implies that the results of these tests met the necessary standards to demonstrate equivalence to the predicate device.
| Test Performed | Implied/Reported Performance |
|---|---|
| Appearance | Acceptable |
| Volume Accuracy | Acceptable |
| Packing | Acceptable |
| Film Thickness in accordance with ISO 4049 | 12 µm |
| Sensitivity to ambient light in accordance with ISO 4049 | Acceptable |
| Polymerization depth in accordance with ISO 4049 | Acceptable |
| Adhesive strength (Dentin, self-etch) in accordance with ISO 11405 | Acceptable |
| Adhesive strength (Enamel, total-etch) in accordance with ISO 11405 | Acceptable |
| pH | Acceptable |
| Dentinal tubule blockage | Acceptable |
Note: For "Film Thickness," a specific value (12 µm) is reported for the subject device. The predicate device's film thickness is listed as 3.4 µm. The document states that the "difference is in chemical compositions; however, the test results of biocompatibility and performance tests supports that the subject device is substantially equivalent to the predicate device." This suggests that despite the difference in this particular metric, it was deemed acceptable within the context of substantial equivalence. For other tests where no specific measurement is given, "Acceptable" is inferred because the conclusion states that the test results support substantial equivalence.
Regarding the remaining requested information (2-9):
The provided document does not contain any of the following information:
- 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 describe a "test set" in the context of an AI/software device. The performance tests are for a physical dental material.
- 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): Not applicable, as the device is not an AI/software device requiring expert adjudicated ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device would be defined by standard material testing protocols and physical/chemical properties, not clinical outcomes or expert labels in the way asked for an AI device.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device.
- How the ground truth for the training set was established: Not applicable.
§ 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.