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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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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.

A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes 3M Clarity Aligners based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using a standard dental software used for tooth alignment, 3M then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. 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. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. 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.

There are no changes being made to the 3M Clarity Aligners themselves. Both the proposed 3M Clarity Aligners and the primary predicate 3M Clarity Aligners (K183159) have the same indications for use. The present premarket submission is to account for the overall software cumulative changes including the integration of the ULab software (K171295).

The provided document is a 510(k) summary for the 3M Clarity Aligners. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a standalone study with performance metrics, human reader studies (MRMC), or a detailed breakdown of sample sizes, ground truth establishment, or expert qualifications for testing and training sets.

The relevant section for performance testing states:
"Results of verification and validation testing demonstrate the proposed 3M Clarity Aligners showed conformity with pre-established specifications and acceptance criteria. Software testing was conducted in accordance with "General Principles of Software Validation; Final Guidance for Industry and FDA Staff'' dated January 11, 2002 and Medical Device Software - Software Life Cycle Processes; ANSI/AAMI/IEC 62304:2015."

This statement confirms that testing was performed against acceptance criteria and established standards, but it does not provide the acceptance criteria themselves, nor the specific performance results or details of the study proving the device met them.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
4. Adjudication method for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human improvement.
6. If a standalone performance (algorithm only) was done (beyond the general statement of "conformity with pre-established specifications").
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document focuses on the claim of substantial equivalence based on the device's identical indications for use, technological characteristics (except for software improvements), and manufacturing processes compared to its predicate device. The software changes are noted to include the integration of ULab software, which allows the Dental Health Professional to directly own and submit the treatment planning process for manufacturing without interaction with 3M technicians.

In summary, while the document states performance testing was conducted, it does not disclose the detailed results or methodologies required to answer your specific questions.

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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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