(88 days)
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.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.