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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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