(94 days)
[1] Direct restorations using light cured composite resin
[2] Cavity sealing as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Intraoral repairs of fractured restorations made of porcelain, ceramic or composite resin
[5] Surface treatment of prosthetic restorations made of porcelain, ceramic or composite resin
[6] Surface treatment of dental posts
[7] Post cementation and core build ups using dual cured composite resin CLEARFIL DC CORE PLUS
[8] Core build ups using light cured composite resin
The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel.
The provided text describes the regulatory submission for a dental bonding agent, CLEARFIL TRI-S BOND PLUS, and references studies conducted to demonstrate its substantial equivalence to predicate devices. However, the document does not contain explicit "acceptance criteria" in a quantitative tabular format or detailed "studies that prove the device meets acceptance criteria" with the specific information requested in your prompt (e.g., sample sizes for test/training sets, data provenance, expert ground truth details, MRMC studies, standalone performance details).
Instead, the submission focuses on demonstrating substantial equivalence based on
- Intended uses
- Chemical ingredients/safety (biocompatibility)
- Technological characteristics/effectiveness and performance.
The document indicates that for effectiveness and performance, "certain tests were performed on this device, in comparison with the predicate device and it was confirmed that this device was substantially equivalent to the predicate device in terms of the effectiveness and performance." Specifically, the following tests are mentioned:
- Tensile bond strength test
- Fluoride releasing property
The results of these tests "exhibited almost the same results for the subject device indicating that the subject device was as effective as and performs as good as or better than the predicate device."
Without the full study reports, which are not included in this summary, the detailed information requested cannot be fully extracted. However, based on the provided text, here's what can be inferred:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from "Substantially Equivalent") | Reported Device Performance |
|---|---|
| Tensile Bond Strength: Comparable to or better than predicate devices (CLEARFIL TRI-S BOND, CLEARFIL DC BOND). | Exhibited "almost the same results" as the predicate device for tensile bond strength, indicating it was "as effective as and performs as good as or better than" the predicate device. |
| Fluoride Releasing Property: Comparable to or better than predicate devices (CLEARFIL TRI-S BOND, CLEARFIL DC BOND). | Exhibited "almost the same results" as the predicate device for fluoride releasing property, indicating it was "as effective as and performs as good as or better than" the predicate device. |
| Biocompatibility: Meet ISO 10993 series and ISO 7405 standards. | 2 new ingredients evaluated with ISO 10993 series and ISO 7405 and "it was confirmed that these substances were biocompatible." All other ingredients previously used in predicate devices with no reported problems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided summary.
- Data Provenance: Not specified in the provided summary.
- The submitter is Kuraray Medical Inc., located in Japan, suggesting the studies likely originated from there, but this is an inference, not stated directly about the data itself.
- The studies were part of a 510(k) submission, typically involving prospective testing for performance evaluations.
3. 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 tests described (tensile bond strength, fluoride release) are objective laboratory measurements, not subjective evaluations requiring expert ground truth in the way medical imaging interpretation might.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for objective laboratory measurements like tensile bond strength or fluoride release.
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
- No, this type of study is not mentioned. The device is a dental bonding agent, not an AI-powered diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. The device is a physical product (dental bonding agent), not an algorithm. Its performance is inherent to the material properties.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For Tensile Bond Strength and Fluoride Releasing Property: The "ground truth" would be the direct measurement of these physical/chemical properties using established laboratory testing protocols, likely aligned with ISO or ASTM standards, and validated against the performance of predicate devices.
- For Biocompatibility: The ground truth was established by evaluation against ISO 10993 series and ISO 7405 standards.
8. The sample size for the training set
- Not applicable. The description refers to a medical device (dental bonding agent), not an AI algorithm that requires a training set. Development of such a product involves formulation and testing, but not in the "training set" sense for AI.
9. How the ground truth for the training set was established
- Not applicable as there is no "training set" in the context of 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.