(57 days)
PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a self-priming bonding agent for use in direct and indirect restorative procedures, for adhesive repairs of amalgams, porcelain/metal and composite, and for an adhesive cavity varnish.
PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is a one-component, no-mix visible light curable dental bonding agent. The new bonding agent consists of a mixture of monomers and an adhesion promoter in an acetone solution. Additionally, the mixture contains photo-initiators, accelerators and polymerization inhibitors which allow for a shelf stable material that can be polymerized using visible light energy. Once the tooth to be restored has been prepared, PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT is applied, left on the surface for 20-30 seconds, air dried, and then light cured for 10 seconds. A second application may be applied for direct restorative procedures, but this is not required for indirect procedures.
This 510(k) summary (K960883) describes a dental bonding agent, PRIME & BOND™ 2.0 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT. The summary focuses on demonstrating substantial equivalence to predicate devices, primarily through the similarity of components and prior toxicity testing on those predicates. It does not provide information directly addressing the performance of the device in terms of quantitative acceptance criteria and a detailed study proving those criteria are met, as would be expected for a device with measurable performance metrics (like diagnostic accuracy). This is common for material-based devices where the primary safety and effectiveness concerns revolve around biocompatibility and mechanical/chemical properties.
Therefore, many of the requested items, particularly those related to diagnostic accuracy studies, human expert adjudication, and AI performance, are not applicable to this submission.
Here's a breakdown of the available information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) summary does not present a table of specific quantitative acceptance criteria or performance metrics (e.g., diagnostic sensitivity, specificity, accuracy). The demonstration of safety and effectiveness relies on:
- Similarity to predicate devices: "All of the components of PRIME & BOND™ 2.0 SELF-PRIMING DENTIN/ENAMEL BONDING AGENT have been used in Dentsply legally marketed predicate devices."
- Prior toxicity testing on predicate devices: "In K931812, Prime & Bond™ Direct Composite Bonding Agent was evaluated for cytotoxicity and for irritation and found to be non-cytotoxic and a non-irritant."
Therefore, the "acceptance criteria" implicitly are that the new device should be as safe and effective as its predicates, and specifically, non-cytotoxic and non-irritant, based on its material composition.
2. Sample size used for the test set and the data provenance
Not applicable. The submission does not describe a clinical performance study with a "test set" in the context of diagnostic accuracy. The safety assessment relies on chemical composition and prior testing of similar components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a diagnostic test set is described.
4. Adjudication method for the test set
Not applicable. No diagnostic test set or adjudication process is described.
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 device is a dental bonding agent, not an AI-powered diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the safety assessment (cytotoxicity and irritation) of the predicate device (K931812), the "ground truth" was established through laboratory testing for cytotoxicity and irritation, rather than expert consensus on clinical cases or pathology.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is described.
In summary: This 510(k) pertains to a medical device (dental bonding agent) that is assessed for substantial equivalence primarily based on its material composition and the known safety profile (non-cytotoxicity, non-irritancy) of its components and predicate devices. It does not involve performance criteria related to diagnostic accuracy or AI algorithms, which are the focus of many of the questions asked.
§ 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.