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The Orthodontic Composite Bracket System is a self-ligating orthodontic bracket uniquely formed in a one piece unit and includes an Adhesive Paste and Adhesive Primer. This system is a bondable device for fixed attached orthodontics.

The Orthodontic Composite Bracket System is a self-ligating orthodontic bracket uniquely formed in a one piece unit and includes an Adhesive Paste and Adhesive Primer.

This document is a 510(k) summary for a medical device called "Opal Prime & Opal Bond/Orthodontic Composite Bracket System." It is a submission to the FDA for market clearance, not a study report detailing performance or acceptance criteria in the manner you've requested.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance, sample sizes for test or training sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

This 510(k) summary primarily focuses on:

• Device Identification: Trade name, common name, classification, and regulation number.
• Predicate Device: Identifying a legally marketed device for comparison to claim substantial equivalence.
• Description and Intended Use: Explaining what the device is and what it's used for.
• Comparison with Predicate Device: Stating that the device is substantially equivalent to a predicate in composition and intended use.
• Regulatory Communication: Correspondence from the FDA granting substantial equivalence.
• Indications for Use: What the device is cleared for.

In the context of a 510(k) submission, "performance" is typically demonstrated through bench testing (e.g., bond strength, material properties) and comparison to the predicate device, rather than the kind of clinical study details you'd find for novel efficacy claims. The document asserts that the device is "substantially equivalent" to a predicate, meaning it performs as well as, or better than, the predicate device for its intended use, and is as safe and effective. However, the specific data for this comparison, including detailed acceptance criteria and the results of tests against those criteria, are not provided in this summary. They would be part of the full 510(k) submission, which is not this public summary document.

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