(29 days)
CLEARFIL SE BOND is indicated for the following applications:
- Direct filling restorations using light-curing composite or compomer
- Cavity sealing as a pretreatment for indirect restorations
- Treatment of hypersensitive and/or exposed root surfaces
- Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured composite resin
- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
CLEARFIL SE BOND 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 painted on the interior of a prepared cavity of a tooth to improve retentive materials.
Here's an analysis of the provided text regarding the acceptance criteria and study for CLEARFIL SE BOND, based on the information available in the 510(k) summary.
It's important to note that the provided document is a 510(k) summary, which is a premarket notification to the FDA. These summaries typically demonstrate substantial equivalence to previously cleared devices rather than presenting full clinical trial results with detailed acceptance criteria and standalone performance studies in the way a pharmaceutical drug or a high-risk medical device might. Therefore, some of the requested information (like specific effect sizes for MRMC studies, sample sizes for test sets, and detailed expert qualifications) is not explicitly present in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Performance: Bond strengths to human enamel, human dentine, precious metal, and porcelain are substantially equivalent to predicate device CLEARFIL LINER BOND 2V (K974486). | The document states: "The bond strengths to human enamel, human dentine, precious metal, and porcelain were evaluated in comparison with predicate devices. The performances are substantially equivalent to those of CLEARFIL LINER BOND 2V." |
While specific numerical values for acceptance thresholds are not provided, the reported performance is that the device met the implicit criterion of "substantial equivalence" in bond strength to the predicate device. |
| Chemical Ingredients and Safety: Chemical ingredients are identical or substantially equivalent to predicate devices and have a history of safe use. | The document states: "The chemical ingredients are identical or substantially equivalent to the predicated devices. These chemical ingredients have been used in similar products which have been marketed for many years, therefore they are safe." The safety of the chemical ingredients is affirmed by their historical use in equivalent predicate devices (CLEARFIL LINER BOND 2V (K974486), PANAVIA F (K983361), ESTENIA (K982164)). |
| Design, Composition, and Function: Device is similar and substantially equivalent in design, composition, and function to predicate devices. | The document explicitly states: "This product is similar and substantially equivalent in design, composition and function to the similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial." This is a general statement of equivalence rather than a specific performance metric. The device is also described as a "simplified system of CLEARFIL LINER BOND 2V". |
| Intended Use: Device performs as intended for specified indications. | The Indications For Use are listed and the claim is that the device is "substantially equivalent" for these uses to predicate devices. Implicitly, it is deemed to perform for: 1) Direct filling restorations, 2) Cavity sealing, 3) Treatment of hypersensitive/exposed root surfaces, 4) Intraoral repairs of fractured crowns, and 5) Surface treatment of prosthetic appliances. The "substantially equivalent" claim implies that it performs comparably to the predicate devices for these indications. |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not specify the sample size used for the bond strength evaluations (test set). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature) for these evaluations. These details are typically part of a more extensive study report, not a 510(k) summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the 510(k) summary. Bond strength testing is usually a laboratory-based biomechanical evaluation, not typically reliant on "expert ground truth" in the way image interpretation or diagnostic accuracy studies might be. Therefore, experts in establishing ground truth in that context would not be applicable here. The "ground truth" would be the measured bond strength values themselves.
4. Adjudication Method for the Test Set
Not applicable for this type of biomechanical bond strength evaluation. Adjudication methods like 2+1 or 3+1 are used for human interpretation of medical images or diagnostic results, not for objective laboratory measurements like bond strength.
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
This is not applicable. The device is a "Resin-based dental adhesive system," a physical material used in dentistry, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are irrelevant to this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated, the device is a dental adhesive system, not an algorithm. The "standalone performance" in this context would be the measured bond strength of the product itself under controlled laboratory conditions, which the document indicates was evaluated by comparing it to predicate devices.
7. The Type of Ground Truth Used
For the bond strength evaluations, the "ground truth" would be the measured bond strength values themselves, obtained through standardized laboratory testing methods (e.g., universal testing machine pulling apart bonded substrates). This is a direct physical measurement.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical product (dental adhesive), not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This is not applicable, as there is no "training set" for this type of 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.