(53 days)
Kerr Nexus One Bottle Adhesive is indicated for all applications where a simple, dependable adhesive is required to bond etched natural tooth structure to composite restorative materials, porcelain, and both precious and non-precious metals.
Kerr Nexus One Bottle Adhesive is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to natural tooth structures ( enamel and dentin ) and to commonly used restorative materials ( composite resin, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques. The organic solvent component allows the application of the adhesive to flow into micro-fissures of the substrate smoothly and when the fast evaporating solvent is removed a thin resin layer remains to form a tight bonding interface between tooth and restorative materials.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Device: Kerr Nexus One Bottle Adhesive (a dental adhesive)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety | |
| Cytotoxicity (MEM Elution Method USP23) | Passed (Independent Laboratory Evaluation by Toxicon Corporation) |
| Mutagenicity (Salmonella Typhimurium REVERSE MUTATION ASSAY (Ames Test)) | Passed (Independent Laboratory Evaluation by Toxicon Corporation) |
| Efficacy / Substantial Equivalence | |
| Bonds etched natural tooth structure to composite restorative materials, porcelain, and both precious and non-precious metals effectively. | "Performs as well or better than PRIME & BOND 2.1 and ONE-STEP" (predicate devices). |
| Provides fast, strong adhesion suitable for all commonly used restorative techniques. | "Produces fast, strong adhesion suitable for all commonly used restorative techniques." |
| Simple to use (one bottle, single step). | "Simple to use and produces fast, strong adhesion... One bottle, single-step dental adhesive." |
| Forms chemical and mechanical adhesive bonds. | "Capable of forming both chemical and mechanical adhesive bonds to natural tooth structures... and to commonly used restorative materials." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for specific efficacy or safety tests within the document. The efficacy is based on "in-house testing and side by side test comparisons." The biocompatibility tests are referred to as "various types of biocompatibility tests," implying multiple tests, but the quantity of samples per test is not mentioned.
- Data Provenance: Not explicitly stated. The document refers to "in-house testing" and tests by an "independent laboratory" (Toxicon Corporation). It's most likely prospective testing conducted specifically for this submission, rather than retrospective analysis of existing data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable or not stated for the technical bench testing.
- Qualifications of Experts: N/A. The evaluation was based on laboratory testing for biocompatibility and bench testing for efficacy against predicate devices. Ground truth here refers to measurable outcomes from these tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The efficacy and safety are determined by objective laboratory tests and comparative bench testing, not by expert consensus on subjective interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This device is a dental adhesive, and its performance is evaluated through physical and chemical bench testing, not through a diagnostic interpretation or a human-in-the-loop scenario that would require an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable in the context of AI. The "standalone" performance here would refer to the intrinsic adhesive properties and biocompatibility of the material itself, which were indeed tested without human interpretation as part of a diagnostic process.
7. The Type of Ground Truth Used
- Type of Ground Truth:
- Safety: Laboratory test results based on established international standards (ISO 10993 for biocompatibility) and specific assays (MEM Elution, Ames Test). The ground truth is the chemical and biological response observed in these standardized tests.
- Efficacy: Bench test results comparing the adhesive properties (e.g., bond strength, flow characteristics) of the Kerr Nexus One Bottle Adhesive against two legally marketed predicate devices (Prime & Bond 2.1 and One-Step). The ground truth is the measurable performance of the adhesive in these controlled laboratory settings, demonstrating "as well or better than" the predicates.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a material-based medical device (dental adhesive), not a machine learning model. There is no "training set" in the context of an AI algorithm. Its development would involve material science research and formulation optimization, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model. The "ground truth" for the development of the adhesive would stem from dental material science principles, empirical testing during product development, and established industry standards for adhesive performance and biocompatibility.
§ 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.