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Optibond Solo Plus 4 is a self-etch primer designed to work in conjunction with a tooth bonding agent. Optibond Solo Plus 4 can be used for indirect situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, post and core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns and bridges (used in conjunction with a resin luting agent).

OptiBond Solo Plus 4 self-etch primer is designed for use with OptiBond Solo Plus adhesive (in Unidose or bottle delivery), both a Class II device which were granted marketing clearance by FDA following the submission of a 510(k) premarket notification. When used with OptiBond Solo Plus or OptiBond Solo Plus with Activator, the self etch primer can be used in the bonding of both direct and indirect restorations. The self-etch primer is used to eliminate the phosphoric acid etch step in the bonding process. Some advantages of using a self etch primer include reduction of post-operative sensitivity and an elimination of steps in the bonding process.

This document is a 510(k) summary for a dental adhesive product, Optibond Solo Plus 4. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study demonstrating acceptance criteria for its performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be fully provided from the given text. The document does not describe specific performance acceptance criteria for the bonding agent, nor does it detail a study designed to test against such criteria.

Here's what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The document's purpose is to demonstrate substantial equivalence, not to define or meet specific performance criteria beyond what is implied by the predicate device's performance.
• Reported Device Performance: Not detailed in terms of specific quantitative outcomes of a performance study. The document broadly states that the device "functions in a manner similar" to predicate devices, implying comparable performance without providing the metrics.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: Not mentioned. No specific "test set" in the context of a performance study is described.
• Data Provenance: Not mentioned. No performance data from clinical or laboratory studies is presented in this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Number of Experts: Not applicable. Given there's no performance study data presented, there's no mention of experts establishing ground truth for such a study.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. No test set or ground truth establishment process is described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This type of study (common in imaging AI) is not relevant to a dental bonding agent and is not mentioned or implied in the document.
• Effect Size of Human Readers with/without AI: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: No. This concept is not applicable to a physical dental bonding agent product.

7. Type of Ground Truth Used:

• Type of Ground Truth: Not applicable. As no performance study with ground truth is described, this information is not available.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm or a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth Establishment for Training Set: Not applicable.

Summary of what the document does provide:

• Device Name: Optibond Solo Plus 4
• Intended Use: Direct situations (composite to enamel/dentin, repair, amalgam sealing, post and core build-up) and indirect situations (veneers, onlays, inlays, crowns, bridges with resin luting agent).
• Predicate Devices: Kuraray America, Inc., Clearfil Liner Bond 2V.
• Claim of Substantial Equivalence: The document asserts that Optibond Solo Plus 4 is substantially equivalent to other legally marketed devices, including the predicate, and "functions in a manner similar to" these. This is the primary "proof" offered for regulatory clearance, not a detailed performance study against specific criteria.

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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.

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OptiBond Solo Plus 3 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials, pit and fissure sealant, and for indirect situations, i.e., veneers, onlays, inlays, crowns, and post cementation.

The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, composite to metal, amalgam sealing, bonding composite core build-up materials and fissure sealant, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.

This is a medical device application for a pit and fissure sealant (OptiBond Solo Plus 3), not an AI/ML device. Therefore, the provided text does not contain information about acceptance criteria, study details, ground truth, or sample sizes related to AI/ML device performance. The document is a 510(k) summary for a traditional medical device demonstrating substantial equivalence to a predicate device.

To answer your request, if this were an AI/ML device, the following information would typically be required but is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: Not applicable.
• Data Provenance: Not applicable.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for Test Set

• Adjudication Method: Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? Not applicable.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable.

6. Standalone Performance Study

• Was a standalone study done? Not applicable.

7. Type of Ground Truth Used

• Type of Ground Truth: Not applicable.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable.

9. How Ground Truth for Training Set Was Established

• How Ground Truth for Training Set was established: Not applicable.

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OptiBond Solo Plus 2 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, , composite to metal, amalgam sealing, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, (used in conjunction with a resin luting agent) post cementation.

The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing and bonding composite core build-up materials, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation.

This document, K991808, primarily concerns the 510(k) summary for the device "OptiBond Solo Plus 2," a dental bonding agent, and its substantial equivalence to a predicate device. As such, the provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document is a regulatory submission for a medical device (a dental bonding agent) and focuses on establishing its substantial equivalence to an existing legally marketed device. It does not detail performance studies with specific acceptance criteria as would be found for more complex diagnostic aid or AI-driven devices.

Therefore, I cannot provide the requested information.

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OptiBond Solo Plus is a multi-purpose bonding agent designed to be used in direct Situations, I.C., composite to enailer and/or dentin, composite repair, porcelain repair, composite to mount, analgain commons, inlays, crowns, Maryland bridges, post cementation.

The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam bonding and bonding composite core build-up materials. Additionally, because the device contains a dual cure catalyst, OptiBond Solo Plus can be used for indirect situations as well including veneers, onlays, inlays, crowns, Maryland bridges and post cementation.

The provided text is a 510(k) Summary of Safety and Effectiveness for a dental bonding agent called "OptiBond Solo Plus." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish acceptance criteria and prove device performance through a detailed study comparing the device against those criteria.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test and training sets, or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study details.
• Standalone performance information.
• Specific details on how ground truth was established for testing or training sets.

The document primarily focuses on:

• Device Name: OptiBond Solo Plus
• Intended Use: Bonding in direct situations (composite to enamel/dentin, composite repair, porcelain repair, composite to metal, amalgam bonding, core build-up materials) and indirect situations (veneers, onlays, inlays, crowns, Maryland bridges, post cementation).
• Predicate Device: Dentsply International, Prime & Bond 2.1
• Claim of Substantial Equivalence: The device functions in a similar manner and is intended for the same use as the predicate device.

To obtain the requested information, one would typically need access to the full 510(k) submission, including any performance studies or validation reports, which are not present in this summary.

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