(35 days)
Clearfil tri-S bond Single dose is indicated for the following applications:
- Direct restorations using light cured composite resin
- Cavity sealing as a pretreatment for indirect restorations
- Treatment of exposed root surfaces
- Core build-ups using light- or dual-cured composite resin
This device is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips).
The provided document is a 510(k) premarket notification for a dental adhesive system, "Clearfil tri-S bond Single dose." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria and device performance in the way typically seen for AI/ML-based medical devices or diagnostic tools.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not applicable as this document describes a traditional medical device (a resin tooth bonding agent) where performance is evaluated through material properties and mechanical tests rather than diagnostic accuracy or human-AI interaction.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Safety: Same as predicate device (K042913) | The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913). The only difference is that it is filled in single dose tips. Therefore, it is considered the same in respect of safety. |
| Effectiveness: Substantially equivalent to predicate | Bond Strengths: Evaluated between bovine tooth and a composite resin, and between bovine dentin and core build-up composite resin. |
| Marginal Sealing: Evaluated. | |
| Results showed the device is substantially equivalent to Clearfil tri-S bond (K042913) in effectiveness. Specific quantitative values are not provided in this summary. |
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: Not specified quantitatively in this summary. The tests were performed "between bovine tooth and a composite resin" and "between bovine dentin and core build up composite resin."
- Data Provenance: Not specified, but given the manufacturer is in Japan, it's likely the testing was conducted in Japan. The study is akin to in vitro or ex vivo testing, not a clinical study on human subjects.
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. This is a material testing study, not a diagnostic study requiring expert ground truth for interpretation. Performance is assessed through physical and mechanical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for clinical or diagnostic studies involving human interpretation. This summary describes material property testing.
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 is not an AI/ML device, nor is it a diagnostic tool that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Direct measurement of material properties: "Bond strengths" and "marginal sealing" are direct measurements or observations of the material's physical performance, not a "ground truth" established by human experts in a diagnostic context. The "truth" is based on the quantifiable physical properties of the materials and their interaction.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device that requires a training set or its associated ground truth establishment.
Summary of Study:
The study described is a comparison of the "Clearfil tri-S bond Single dose" device to its predicate device, "Clearfil tri-S bond (K042913)," focusing on material properties and performance. The primary findings are:
- Safety: The device is considered safe because its ingredients and composition are identical to the predicate device, with the only difference being the single-dose packaging.
- Effectiveness: The device demonstrates substantial equivalence to the predicate in effectiveness, as evidenced by comparable "bond strengths" (between bovine tooth/composite and bovine dentin/core build-up) and "marginal sealing."
The 510(k) summary asserts substantial equivalence based on these comparisons, indicating that the new device performs at least as well as the legally marketed predicate device for its intended uses. No quantitative results for bond strength or sealing are provided in this summary, only the statement of substantial equivalence.
§ 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.