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

3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force. 3M™ Clarity™ Aligners-Flex) 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 present Premarket Submission is for the simplification in the number of formulations of the aligner material. This simplification allows for streamlined manufacturing processes so that both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be composed of the same material with differing flexibilities. The aligners will still be named 3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex).

3M is offering a treatment plan with two different aligner flexibilities where the dental health professional will determine which degree of flexibility to use during the treatment plan. 3M Clarity Aligners-Flex is designed to be more flexible thereby increasing patient comfort and ease of insertion and removal. 3M Clarity Aligners-Force is designed to be more rigid increasing the force persistence. 3M will continue to offer the option of combination treatment plans where both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be used.

A dental health professional (e.g., orthodontist or dentist), prescribes 3M™ Clarity™ Alieners (3MTM Clarity™ Aligners-Force, 3MTM Clarity™ Aligners-Flex) based on an assessment of the patient's teeth and determines a course of treatment with the system. Patient data is collected via intra-oral scanning or taking physical impressions. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved. 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. The dental care professional monitors treatment from the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

This document is a 510(k) Premarket Notification for the 3M™ Clarity™ Aligners. The core purpose of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (K211190) rather than to present a study proving the device meets specific acceptance criteria for clinical performance that would allow it to be used as a standalone diagnostic or screening tool.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the performance testing conducted to show that the new material formulation of the aligners does not negatively impact safety and effectiveness compared to the predicate device. The information provided heavily focuses on bench testing and biocompatibility rather than clinical efficacy studies.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a direct table of acceptance criteria with numerical targets and corresponding device performance values in detail. Instead, it states that "All performance testing shows acceptable results for all tested samples." The acceptance is based on demonstrating that the subject device's performance is comparable or equivalent to the predicate device, especially considering the change in material.

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

The document does not specify the exact sample sizes for each type of performance testing (translucency, abrasion, etc.). It generally refers to "all tested samples" from "bench testing." The data provenance is internal to 3M™ Company, arising from their in vitro and ex vivo laboratory testing. This is retrospective data collected for regulatory submission purposes. There is no information about country of origin for the data that would be relevant to clinical studies in this context.

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

This question is not directly applicable in the context of this 510(k) submission, as it relates to clinical efficacy studies or diagnostic performance evaluations. The "ground truth" here is established by the accepted scientific and engineering principles for material and device performance testing. For biocompatibility, a "Diplomate of the American Board of Toxicology" assessed the safety.

4. Adjudication Method for the Test Set:

Not applicable, as this is primarily a bench testing and material change submission, not focused on human interpretation of clinical data in a test set.

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 submission is for an orthodontic aligner device, not an AI-assisted diagnostic or imaging device.

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

Not applicable. This is a physical medical device, not a software algorithm. While software is used in the manufacturing process, the submission does not present performance data for the software itself in a standalone context.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance testing is based on established scientific and engineering standards for material properties and device functionality, often evaluated against the previous (predicate) device's performance, as well as relevant ISO standards (e.g., ISO 10993 for biocompatibility) and FDA guidance documents. For biocompatibility, the assessment by a board-certified toxicologist serves as the expert evaluation.

8. The Sample Size for the Training Set:

Not applicable. This submission focuses on a physical device and its material properties, not an AI algorithm requiring a training set.

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

Not applicable, as there is no training set for an AI algorithm.

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

The 3M Clarity Aligners, 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force 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 present Premarket Submission is for the addition of a new form of the aligner called 3M Clarity Aligners-Flex to the 3M Clarity Aligner system. 3M will continue to offer aligners composed of the same material as previously cleared (K192119) as 3M Clarity Aligners-Force. 3M will offer the option of combination treatment plans where both 3M Clarity Aligners-Flex and 3M Clarity Aligners-Force can be used.

A dental health professional (e.g. orthodontist or dentist), prescribes 3M Clarity Aligners, 3M Clarity-Flex, 3M Clarity Aligners-Force based on an assessment of the patient's teeth and determines a course of treatment with the system. Patient data is collected via intra-oral scanning or taking physical impressions. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.

This document outlines the acceptance criteria and the study proving the device meets these criteria for the 3M™ Clarity™ Aligners (Force and Flex), based on the provided FDA 510(k) submission summary.

Executive Summary:

The 3M™ Clarity™ Aligners-Flex device is being introduced as an addition to the already cleared 3M™ Clarity™ Aligner system (predicate device K192119). The primary difference is the introduction of a new material, "3M Flex Thermoplastic Material", alongside the existing "3M Force Thermoplastic Material". The submission argues for substantial equivalence by demonstrating that the new material and combination treatment plans do not alter the fundamental indications for use, manufacturing processes, design, or device features as compared to the predicate device. Performance testing confirms acceptable results for optical properties, mechanical stability, staining, transportation, use life, force, and conditioning. Biocompatibility testing was also conducted and found the product safe for its intended use.

Acceptance Criteria and Device Performance Study

The provided 510(k) summary does not detail explicit quantitative acceptance criteria with specific performance metrics such as sensitivity, specificity, accuracy, or AUC that would typically be associated with AI/ML diagnostic or prognostic devices. Instead, the acceptance criteria appear to be qualitative and relate to demonstrating that the new 3M™ Clarity™ Aligners-Flex are substantially equivalent to the predicate device (3M™ Clarity™ Aligners, K192119) across various performance aspects, particularly concerning its physical and material properties, and its continued safety and efficacy for its stated indications.

The "study" in this context refers to the performance testing conducted to support the substantial equivalence claim, rather than a clinical trial comparing the diagnostic accuracy of an AI system.

Here's an interpretation of the acceptance criteria and reported performance based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document states "acceptable results for all tested samples" for the performance testing (optical properties, mechanical stability, etc.). However, it does not specify the exact number of samples used for each test.
• Data Provenance: The document does not specify the country of origin of the data. It's implicitly retrospective in the sense that the testing was conducted prior to submission to demonstrate equivalency, but it's not a clinical study on patients. The data is derived from laboratory and material testing.

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

• This information is not applicable to this submission. The "ground truth" here is not based on expert clinical consensus or interpretation of medical images/data, but rather on direct physical and material property measurements and biocompatibility testing against established standards. The device is a physical orthodontics product, not an AI diagnostic tool requiring expert ground truth for a test set.

4. Adjudication Method for the Test Set

• This is not applicable. There is no "adjudication" in the sense of resolving discrepancies in expert interpretations, as the testing involves objective physical measurements and adherence to material standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• This is not applicable. The device is an orthodontic aligner, not an AI diagnostic or assistive tool. Therefore, no MRMC study, AI assistance, or human reader improvement effect size is relevant to this submission.

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

• This is not applicable. This describes a physical medical device (orthodontic aligner) and not an AI algorithm. While it leverages proprietary CAD/CAM software in its manufacturing, the submission does not present performance data for the software in a standalone "algorithm only" context, as the software's performance is intrinsically linked to the physical output of the aligners.

7. The Type of Ground Truth Used

• The "ground truth" for this device is based on objective physical and chemical properties measurements, engineering specifications, and established biocompatibility standards. It's not clinical outcomes data, pathology, or expert consensus in a diagnostic sense. The ground truth for the "acceptability" of these measurements is predefined by internal company specifications and relevant industry/regulatory standards (e.g., ISO standards for plastics, FDA guidance for biocompatibility).

8. The Sample Size for the Training Set

• This is not applicable. The device is a manufactured physical product. There is no "training set" in the context of machine learning or AI algorithm development. The manufacturing processes are established through engineering design, material science, and quality control, not data training.

9. How the Ground Truth for the Training Set was Established

• This is not applicable for the same reason as point 8.

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