(87 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 and core build-ups
[7] Cementation of inlays, onlays, crowns, bridges and veneers
The subject device is a single-component, light-cured bonding agent that allows simultaneous treatment of both dentin and enamel. Depending on the adhesive is used as self-etching or with phosphoric acid for selective enamel etching or total-etching procedures. This product is intended to be used for both direct and indirect restorations.
"CLEARFIL DC Activator" activates the dual-curing mechanism of this product; however, the addition of "CLEARFIL DC Activator" to the adhesive is not required when using with "CLEARFIL DC CORE PLUS" or "PANAVIA SA CEMENT"
This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.
The provided text is for a dental bonding agent (CLEARFIL Universal Bond, Kuraray Noritake Dental Inc.). This type of device does not typically involve AI, image analysis, or diagnostic capabilities that would require the detailed acceptance criteria and study designs you've requested regarding AI performance.
Therefore, many of the requested points are not applicable to this submission. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use, chemical ingredients/safety, and technological characteristics/performance through in vitro tests, not clinical studies with human readers or AI.
Here's a breakdown of what can be extracted and what is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not detail specific quantitative acceptance criteria or performance metrics for in vitro tests. Instead, it states a qualitative conclusion regarding performance compared to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Performance not significantly different or not less than predicate devices | "the performance of the subject device was not significantly different or not less than that of the predicate devices." |
| Substantially equivalent in safety to predicate devices (chemical ingredients, no reported problems/recalls for predicates) | "All ingredients in the subject have been used in the predicate devices. Regarding the predicate devices, there have not been any reported problems or recalls... it was concluded that the safety of the subject device was substantially equivalent..." |
2. Sample size used for the test set and the data provenance
- Not Applicable: This device is not an AI diagnostic tool and does not use a "test set" in the context of AI model evaluation. The tests performed were likely in vitro (laboratory tests) to assess bonding strength, durability, etc., but no details on sample size or data provenance (country of origin, retrospective/prospective) are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: Ground truth as described (e.g., established by radiologists) is not relevant for this type of dental material.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: No adjudication method is described, as it's not a diagnostic device.
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-assisted diagnostic device, so no MRMC study or AI-human improvement metrics are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
- Not Applicable/Implied by comparison: For dental materials, "ground truth" often refers to scientifically validated physical, chemical, or biological properties obtained through standardized laboratory testing. The document states "certain tests were performed on this device considering its intended uses, in comparison with the predicate device," implying the ground for comparison came from standard material testing protocols.
8. The sample size for the training set
- Not Applicable: This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: As above, no training set.
§ 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.