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3M™ Clarity™ Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion.

The 3M Clarity Aligners are a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.

The provided document is a 510(k) summary for the 3M Clarity Aligners. It describes that this submission is primarily to change the Indications for Use by removing a treatment limitation. It explicitly states: "No additional testing has been included on this submission. Biocompatibility tests, performance testing and software verification and validation testing data was previously submitted and reviewed to support clearance of the predicate device 3M Clear Tray Aligner under premarket notification K163689."

Therefore, based on the provided document, there is no new study or acceptance criteria analysis present for the 3M Clarity Aligners in this particular submission (K183159). The substantial equivalence relies on previous clearances.

However, I can extract the information related to the device's characteristics and the basis for its substantial equivalence to its predicates.

Here's a breakdown of the requested information based on the provided text, with the understanding that new testing was not performed for this specific submission:

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

• Acceptance Criteria for K183159: The primary acceptance criterion for this submission (K183159) is that the 3M Clarity Aligners, with the revised Indications for Use, remain substantially equivalent to the predicate devices (Invisalign® System (K081960) and 3M Clear Tray Aligner (K163689)). This is based on the argument that the change in indication does not affect design, material, manufacturing processes, or software, which were all previously cleared.
• Reported Device Performance: The document does not report new performance data for K183159. It asserts that the device's technological characteristics, design, material composition, device features, and manufacturing processes remain the same as the previously cleared 3M Clear Tray Aligner (K163689).

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

• The document explicitly states: "No additional testing has been included on this submission." Therefore, no new sample size or data provenance information from a test set is provided for this specific submission. The reliance is on data from the K163689 submission.

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 for this submission (K183159) as no new testing was performed.

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

• Not applicable for this submission (K183159) as no new testing was performed.

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

• Not applicable. This device is a physical aligner and not an AI/imaging diagnostic device that would involve human readers or AI assistance in that context.

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

• Not applicable. This device is a physical aligner. The software mentioned is for the "Ordering Workflow" and not for diagnostic or treatment planning automation that would typically require standalone performance testing in the context of an algorithm.

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

• Not applicable for this submission (K183159) as no new testing was performed. For the original clearance of K163689 (or the predicate Invisalign K081960), the "ground truth" for orthodontic devices typically refers to their ability to achieve desired tooth movements as planned by orthodontists, potentially validated through clinical outcomes, but this document does not detail such studies for K163689 either.

8. The sample size for the training set

• Not applicable for this submission (K183159) as no new testing was performed for a modeling or AI component that would require a training set. The software is for ordering workflow.

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

• Not applicable for this submission (K183159) as no new testing was performed for a modeling or AI component that would require a training set.

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