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The Clear21™ orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.

The Clear21™ orthodontic ceramic bracket system from World Class Technology Corporation is a system of aesthetic passive self-ligating brackets for fixed appliance orthodontic treatment. The brackets are bonded directly to patient's teeth of the maxillary arch. The self-ligating mechanism (i.e. the door) eliminates the need for elastomeric and steel ligatures. The system is intended for use with clinician chosen orthodontic auxiliary devices.

The requested information is not available in the provided document. The document describes a 510(k) premarket notification for an orthodontic ceramic bracket system (Clear21) and primarily focuses on proving its substantial equivalence to a legally marketed predicate device (Damon Clear/Clear2) through non-clinical testing.

Here's a breakdown of why the requested information about AI acceptance criteria and study proving device performance against those criteria cannot be extracted from this document:

• Device Type: The Clear21 is an orthodontic ceramic bracket system, which is a physical medical device used for moving teeth. It is not an AI-powered device or software.
• Study Focus: The "Performance Data" section (page 6) explicitly states "Non-Clinical Testing" and "Functional testing was done to compare the Clear21 bracket's performance to that of its predicate and reference devices." It further clarifies, "Clinical Testing - Clinical testing is not included in this submission."
• Lack of AI-related metrics: The performance criteria discussed relate to mechanical properties of the bracket (ligation mechanism, structural integrity, bond strength, door open/close force, door pull-out, rotational strength, hook strength). There are no metrics related to AI performance such as sensitivity, specificity, AUC, or reader performance with or without AI assistance.
• Ground Truth: The ground truth for this device would be its physical properties and mechanical performance, not expert consensus on image interpretation or pathology.
• No mention of experts or adjudication: Since it's a physical device and not an AI-assisted diagnostic tool, there's no mention of experts establishing ground truth for a test set or any adjudication methods.
• No training set or MRMC study: As there is no AI component, there are no training sets or MRMC studies to evaluate human reader improvement with AI.

Therefore, the document does not contain the information required to answer the prompt regarding AI acceptance criteria and the study proving a device meets those criteria.

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