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

3M™ Clarity™ Aligners with Quick Attachments, is a clear plastic sequential aligner 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. 3M™ Clarity™ Aligners with Quick Attachments utilize the option of pre-formed and pre-cured attachments offering a more accurately shaped attachment. Attachments help create forces on the tooth which can assist aligner retention or optimized aligner force system for tooth movement. 3M Clarity Aligners with Quick Attachments provide the option to form the attachments via an empty attachment template that is filled with adhesive and cured on the teeth or by pre-formed 3D printed custom attachments. The aligners, with or without attachments, are for orthodontic treatment of malocclusions.

The provided document describes the 3M™ Clarity™ Aligners with Quick Attachments and its substantial equivalence to a predicate device, 3M™ Clarity™ Aligners (K231464).

Acceptance Criteria and Device Performance:

The document states that the proposed Quick Attachment alternative attachment delivery mechanism completed functional and performance testing, including but not limited to abrasion, bond strength, flexural strength, and stain resistance. The conclusion drawn is that the alternative Quick Attachment delivery mechanism does not impact the safety and effectiveness profile of the 3M™ Clarity™ Aligners and is substantially equivalent to the predicate device.

However, the document does not provide a specific table of acceptance criteria with numerical targets and the reported device performance against those targets. It only states that testing was performed and that the device met the safety and effectiveness profile.

Regarding the study that proves the device meets the acceptance criteria, the following information is available from the document:

This document summarizes a 510(k) premarket notification, which establishes substantial equivalence, implying that the new device is as safe and effective as a legally marketed predicate device. In this context, detailed "acceptance criteria" and "study results" in the format typically seen for a new drug or high-risk medical device might not be explicitly outlined with quantitative data in this summary. Instead, the focus is on demonstrating that the modifications (Quick Attachments) do not alter the safety and efficacy profile from the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The specific numerical acceptance criteria and detailed quantitative results for abrasion, bond strength, flexural strength, and stain resistance are not provided in this 510(k) summary.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for the functional and performance testing for the Quick Attachments. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document. The tests mentioned (abrasion, bond strength, flexural strength, stain resistance) are typically objective laboratory or mechanical tests rather than those requiring expert ground truth in a clinical sense.

4. Adjudication Method for the Test Set:

This information is not applicable and is not provided in the document, as the tests described are objective performance tests.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study is mentioned. This type of study is more relevant for diagnostic imaging devices where human readers interpret results.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical orthodontic product, and the testing described relates to its physical and material properties. There is no mention of an algorithm or AI component in this context.

7. Type of Ground Truth Used:

The "ground truth" for the functional and performance testing (abrasion, bond strength, flexural strength, stain resistance) would be the established scientific and engineering standards and methods for measuring these material properties. It is not an expert consensus, pathology, or outcomes data in the clinical sense for this type of device.

8. Sample Size for the Training Set:

Not applicable. The document describes functional and performance testing of a physical device component, not an AI or algorithm that would require a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned or implied for this device.

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