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The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.

The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments.

The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping.

The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.

This document is a 510(k) premarket notification for a medical device, specifically an orthodontic appliance. It primarily focuses on demonstrating substantial equivalence to existing devices rather than detailing a study proving the device meets specific acceptance criteria through performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of an AI/human-in-the-loop diagnostic device, cannot be fully extracted from this document. This document describes a physical orthodontic appliance, not a diagnostic algorithm.

However, I can extract information related to performance testing that was conducted:

Here's an attempt to answer your questions based only on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of the document.

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not explicitly provided for biocompatibility or bond strength testing.
• Data Provenance: Not provided. The tests are described as conducted in accordance with FDA and ISO standards, but the location or whether the data was retrospective/prospective is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. This document does not describe a study involving expert assessment or ground truth establishment for a diagnostic algorithm. The "ground truth" for the bond strength appears to be the measured force required for bonding/debonding, and for biocompatibility, it's compliance with standard biological evaluation tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. No adjudication method is mentioned as this is not a diagnostic study requiring human expert review for establishing ground truth.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. A MRMC comparative effectiveness study was not done. This document is for a physical orthodontic appliance, not an AI-assisted diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. A standalone performance study of an algorithm was not done. This document is for a physical orthodontic appliance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• For Biocompatibility: Compliance with established biological evaluation standards (ISO 10993). The "ground truth" is that the material does not elicit adverse biological responses.
• For Bond Strength: Measured force in lbf/MPa. The "ground truth" refers to the quantified mechanical adhesion strength.

8. The sample size for the training set

• Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established

• Not Applicable. No training set or associated ground truth establishment is relevant to this device submission.

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