(97 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] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation using a dual- or self-cured composite resin
[7] Core build-ups using a light-, dual- or self-cured core material
[8] Cementing inlays, onlays, crowns, bridges and veneers using a composite resin cement
The subject device is a two component, self-etch, light-cured bonding agent, which is intended for universal use for both direct and indirect restorations. The PRIMER allows simultaneous treatment of both dentin and enamel using one liquid. The product is activated by a dual-cure mechanism when the BOND is mixed with CLEARFIL DC Activator. This allows it to be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.
This document is a 510(k) summary for a dental bonding agent, CLEARFIL SE BOND 2. It's a regulatory submission to the FDA and therefore lacks the typical detailed study information you'd find in a peer-reviewed publication. Dental bonding agents are typically evaluated through benchtop tests rather than large-scale clinical studies with human readers, multi-reader multi-case studies, or complex ground truth requirements like pathology or outcomes data in the way medical imaging AI devices are.
However, I can extract the available information regarding acceptance criteria and the study performed, even if it's limited in scope compared to your requested format for AI/imaging devices.
1. Table of Acceptance Criteria and Reported Device Performance
The document states there are no international standards for the performance of this type of device. Therefore, a comparative approach against predicate devices was used. The key performance metric mentioned is tensile bond strength.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Tensile bond strength not significantly different or not less than that of predicate devices | Each tensile bond strength of the subject device was not significantly different or not less than that of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not explicitly stated. The document mentions "certain tests were performed on this device" but does not detail sample sizes for these tests.
- Data Provenance: Not specified. Given it's a submission from a Japanese company (Kuraray Noritake Dental Inc.), the tests were likely conducted internally or by a contracted lab. The document does not specify if it's retrospective or prospective; however, these would be benchtop tests, not clinical studies in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Number of Experts: Not applicable. For tensile bond strength and other physical/chemical properties of dental materials, the "ground truth" is established through standardized laboratory testing protocols, not by expert consensus or interpretation in the way medical images are.
- Qualifications of Experts: Not applicable in the context of expert review for ground truth. The tests would be performed by lab technicians or scientists following established ISO or internal protocols for material testing.
4. Adjudication Method for the Test Set
- Adjudication method: Not applicable. As ground truth is established through physical/chemical testing, there is no need for expert adjudication of results.
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
- MRMC Study: No. This is a dental material, not an AI or imaging device that involves human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a dental material, not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: Physical/chemical properties determined through laboratory testing (specifically, tensile bond strength as mentioned). This is a direct measurement based on established test methodologies for material science, rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: Not applicable. There is no training set for this type of device.
Study Summary:
The study performed was a benchtop comparative effectiveness study where the tensile bond strength of the CLEARFIL SE BOND 2 was compared against its predicate devices. The study aimed to demonstrate that the subject device's performance was "not significantly different or not less than" that of the predicate devices in terms of tensile bond strength. This approach was taken because "there have not been any international standards concerning performance of this type of device." No specific details on the methodology, number of samples, or statistical analysis are provided in this summary. The safety evaluation was based on the chemical ingredients being equivalent to predicate devices with no reported post-market problems.
§ 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.