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Solo Ortho 3 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 3 can be used with either chemical or light cured adhesive systems.

Given the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or any of the other specific details requested in the prompt for the Solo Ortho 3 device.

The document is a 510(k) summary for the Solo Ortho 3 orthodontic bonding primer, stating its substantial equivalence to a predicate device (Solo Ortho 2). It provides administrative details, device description, intended use, and the FDA's clearance letter.

Therefore, I cannot fulfill the request for a table of acceptance criteria, study details, or other performance-related information based on the provided input.

The document does not describe:

• Any performance studies (clinical or benchtop) to demonstrate the device meets specific acceptance criteria.
• Quantitative performance metrics or benchmarks.
• Data provenance, sample sizes, or details about ground truth establishment.
• Any multi-reader multi-case (MRMC) or standalone performance studies.

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Solo Ortho 2 is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

The device is a one-bottle, universal primer for labial and lingual bonding of ceramic or metal brackets. Solo Ortho 2 can be used with either chemical or light cured adhesive systems.

This document is a 510(k) Summary of Safety and Effectiveness for a medical device called "Solo Ortho 2," an orthodontic bonding primer. It focuses on demonstrating substantial equivalence to a predicate device, not on presenting a study to prove acceptance criteria using the specified structure for AI/ML medical devices. Therefore, I cannot generate the requested table and information based on the provided text.

The document is primarily a regulatory submission for premarket notification to the FDA, asserting that Solo Ortho 2 is substantially equivalent to a previously marketed device (Solo Plus Ortho). It does not contain information about:

• Specific acceptance criteria in terms of performance metrics (like accuracy, sensitivity, specificity).
• A "study" designed to meet such criteria with reported device performance.
• Sample sizes for test sets, data provenance, expert ground truth establishment, or adjudication methods for an AI/ML device.
• MRMC comparative effectiveness studies or standalone algorithm performance.
• Training set details for an AI/ML model.

In summary, the provided text describes a traditional medical device (an orthodontic primer) and its regulatory submission, which is not an AI/ML device, and thus does not contain the information required to fill out the requested table and answer the study-specific questions.

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Solo Ortho is designed to be used as an enhancing primer for labial and lingual orthodontic bonding.

The device 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 both natural tooth structure, e.g., enamel and dentin, to commonly used restorative materials, e.g., composite resins, porcelain and metals. Due to the chemistry of this device is also suitable as a universal primer for labial and lingual bonding of ceramic or metal brackets.

This document is a 510(k) summary for the Solo Ortho orthodontic bonding primer. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study to prove they are met is not available in the provided text.

However, I can extract the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided. The document focuses on substantial equivalence based on similar function and intended use, not on specific performance metrics or acceptance criteria.

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

Not applicable. No performance study data is presented. The substantial equivalence claim is based on the device description and intended use being similar to a predicate.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No performance study data is presented.

4. Adjudication Method for the Test Set:

Not applicable. No performance study data is presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. An MRMC study was not done or reported in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

Not applicable. The device is a physical orthodontic bonding primer, not an algorithm or AI.

7. The Type of Ground Truth Used:

Not applicable. No ground truth is established as no performance study is described. The basis for substantial equivalence is comparison to a predicate device for intended use and function.

8. The Sample Size for the Training Set:

Not applicable. No training set is mentioned as this is a physical device and not an AI/ML product.

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

Not applicable. No training set or ground truth for a training set is mentioned.

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