Search Results

OptiBond Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with a tooth bonding agent. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and cementation of posts and amalgams.

OptiBoud Solo Plus Activator is a multi-purpose bonding agent designed to work in conjunction with Optitloud Solo Phus, a Class II device which was granted marketing clearance by FDA following the submission of a 510(k) premarket notification. OptiBond Solo Plus Activator can be used for the bonding of core materials, resin cements, and comentation of posts and amalgams.

The provided text is a 510(k) summary for the OptiBond Solo Plus Activator, a dental resin bonding agent. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific performance criteria through a detailed clinical study in the way a new medical device would.

Therefore, many of the requested categories related to clinical study design, ground truth, and expert evaluation are not applicable to this document. The focus of this 510(k) is on demonstrating similarities in function and intended use to an already marketed device, not on proving de novo clinical effectiveness.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. The document states that a table comparing bonding properties is included, but the table itself (with specific data and sample sizes) is not present in the provided text. This is a substantial equivalence claim, so the "test set" in the context of a clinical trial for performance is not relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. This information pertains to a clinical efficacy or performance study, which is not the primary subject of a 510(k) summary for this type of device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. As above, this relates to clinical study design, which isn't detailed in this 510(k) summary.

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 or assistive technology. Therefore, an MRMC study or AI-related metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. As above, this relates to AI/software performance, not a dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. The "ground truth" for a chemical bonding agent would typically be measured through laboratory tests (e.g., bond strength, shear strength) or potentially clinical outcomes, but the specific methodologies and their "ground truth" establishment are not detailed in this 510(k) summary. The document mentions a comparison of "bonding property," suggesting laboratory-based performance metrics rather than expert consensus on clinical outcomes.

8. The sample size for the training set

• Not applicable / Not provided. This concept (training set) applies to machine learning models, not to a chemical dental product.

9. How the ground truth for the training set was established

• Not applicable / Not provided. This concept (training set ground truth) applies to machine learning models, not to a chemical dental product.

Summary of Study (Based on 510(k) Content):

The provided text indicates that Sybron Dental Specialties, Inc. submitted a 510(k) premarket notification (K012082) for their device, OptiBond Solo Plus Activator. The "study" mentioned is a substantial equivalence comparison to a legally marketed predicate device, Dentsply Caulk's Prime & Bond NT Dual Cure (510(k) K982394).

The basis for substantial equivalence is that OptiBond Solo Plus Activator:

• Functions in a manner similar to the predicate device.
• Is intended for the same use: bonding of core materials, resin cements, and cementation of posts and amalgams.

The document states: "The table on the following page compares the bonding property of OptiBond Solo Plus Activator to one other legally marketed...device." This implies that laboratory testing of a "bonding property" was conducted and compared to the predicate device's performance. However, the details of this specific testing (e.g., specific bond strength values, sample sizes for that comparison, methodology) are not included in the provided text.

The FDA's letter (Page 2) confirms that they reviewed the 510(k) and determined the device to be substantially equivalent based on the information provided by the submitter.

Ask a specific question about this device