(84 days)
to promote strong bonds to enamel and dentin for a) direct restorative materials such as composite resins, compomers, amalgam, and b) resins cements used in the bonding of indirect restorative materials, such as ceramic veneers, inlays, and crowns.
to seal dentinal tubules
to reduce sensitivity due to exposed tubules in abrasion/erosion lesions of teeth
to promote bonds between incremental layers of composite resins when building a composite restoration
to bond composite resins repairs to ceramics and metals
Adhere is an adhesive system used for the bonding of directly and indirectly placed restorative materials to tooth structure. It consists of surface conditioners, primers, an adhesive resin, initiators and accessories for applying the components to tooth surfaces. After tooth conditioning, a primer is applied, and an adhesive resin overlayer is subsequently placed on the surface to interact with restorative materials. Other primers are used for surface reactions with indirect restorative materials.
The provided text describes a 510(k) submission for a dental bonding system called "Adhere" (K99283Y). It focuses on establishing substantial equivalence to predicate devices based on performance and component use. However, the document does not explicitly detail specific quantitative acceptance criteria or a dedicated study design/results that prove the device meets these criteria in the way typically expected for medical AI device submissions.
Instead, the submission for "Adhere" relies on the established performance of its predicate devices and the general understanding that its components and intended use align with these devices. This type of submission (from 1999) predates the rigorous requirements for AI/ML-based medical devices that necessitate detailed performance metrics, ground truth establishment, and statistical studies.
Based on the provided information, I can extract and infer some aspects, but it's crucial to understand that many requested details (especially those related to AI/ML device studies like sample sizes, expert qualifications, adjudication, MRMC, and training sets) are not present in this 1999 510(k) submission for a dental bonding agent.
Here's an attempt to answer based on the provided text, highlighting what is available and what is not:
Acceptance Criteria and Device Performance Study (Adhere - K99283Y)
This 510(k) summary for Adhere, a dental bonding system, primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a standalone study with explicit quantitative acceptance criteria for device performance as would be expected for an AI/ML device. The "performance" mentioned refers to its ability to bond restorative materials and reduce tooth sensitivity, consistent with its intended use and the function of predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a dental bonding agent from 1999, the "acceptance criteria" are implied by the performance of predicate devices in achieving strong bonds and reducing sensitivity. Explicit quantitative metrics and reported performance values are not provided in this summary. Instead, the claim is that Adhere's performance is substantially equivalent to these devices.
| Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|
| Ability to bond restorative materials to enamel and dentin | Substantially equivalent to predicate devices (Optibond, All Bond 2, One Step, Silane Bond Enhancer) in achieving strong bonds for composites, compomers, amalgam, ceramic veneers, and ceramic inlays. |
| Ability to seal dentinal tubules | Substantially equivalent to predicate devices in sealing dentin. |
| Ability to reduce tooth sensitivity | Substantially equivalent to predicate devices in reducing sensitivity in non-bacterial mediated cervical lesions. |
| Promotion of composite bonds to ceramics and metals | Substantially equivalent to predicate devices in promoting bonds. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided. This information is typically relevant for quantitative performance studies, especially for AI/ML devices. For this dental bonding material, the assessment of substantial equivalence would have likely involved chemical composition analysis, mechanical bond strength testing (pre-clinical), and potentially some clinical observations, but the details of such "test sets" for these specific criteria are not in the summarized document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable/Not provided. The concept of "ground truth established by experts" in this context is not directly addressed. The performance claims are based on the known science of dental adhesives and comparison to existing products.
4. Adjudication Method for the Test Set
Not applicable/Not provided. This is a concept related to clinical trials or performance studies involving human assessment, which is not detailed here for this type of device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study (MRMC) is generally performed for diagnostic imaging devices or AI-assisted diagnostic tools where human readers interpret medical images. Adhere is a dental bonding agent, and such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. Adhere is a physical dental material, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for a dental bonding agent is typically established through:
- Mechanical Testing: Bond strength (shear, tensile) measured in laboratory settings using standardized protocols on extracted teeth or simulated tooth structures.
- Clinical Efficacy/Safety Data: While not detailed here, prior clinical use of similar materials and possibly clinical observations from trials (not elaborated in the summary) would form the basis for "ground truth" regarding its effectiveness in living patients.
- Chemical/Material Analysis: Demonstrating the chemical properties and components align with established, safe, and effective materials.
Given the 510(k) nature, the "ground truth" largely refers to the accepted performance standards and outcomes observed with the predicate devices.
8. The Sample Size for the Training Set
Not applicable/Not provided. As this is a traditional medical device (dental material) and not an AI/ML device, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided. See the explanation for point 8.
§ 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.