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The Orthodontic Composite Bracket System is a self-ligating, orthodontic bracket unquely The Orthodonite Composite Dracter By Midhesive Paste and Adhesive Primer. This system is a bondable device for fixed attached orthodontics.

Orthodontic Composite Bracket System

I am sorry, but the provided text does not contain the detailed information necessary to fully answer your request. The document is an FDA 510(k) clearance letter for an "Orthodontic Composite Bracket System," indicating it has been found substantially equivalent to a predicate device.

However, it does not include:

• Acceptance criteria for the device's performance.
• The details of any study (including sample sizes, data provenance, ground truth establishment, expert qualifications, or adjudication methods) that would demonstrate the device meets acceptance criteria.
• Information about MRMC comparative effectiveness studies or standalone algorithm performance.
• Training set information for any AI/algorithm (as this device appears to be a physical orthodontic bracket system, not an AI software).

This document simply states that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed devices. It confirms the device's regulatory class and product codes but does not delve into the specific performance studies that might have been submitted by the manufacturer to support their claims.

Therefore, I cannot generate the table or provide the detailed study information you requested based on this text.

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