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.

AI/ML Overview

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

Category / Performance Aspect	Acceptance Criteria (Implied)	Reported Device Performance
Indications for Use	Must align with the predicate device (alignment of teeth during orthodontic treatment of malocclusion).	"Clarity Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion." (Identical to predicate). The addition of 3M Clarity Aligners-Flex and combination treatment plans maintains this indication.
Manufacturing Process	Must be consistent with or equally robust as the predicate device's automated state-of-the-art process.	"No change" compared to the predicate device's manufacturing process.
Device Design/Features	Must maintain the same design and device features as the predicate device.	"3M Clarity Aligners-Flex and the previously cleared 3M Clarity Aligners (K192119) have the same design, device features, software as well as their manufacturing processes." Also, "Orthodontic tooth movements occur through forces applied to the dentition as each tooth follows the programmed displacement based on a doctor's prescription" (No change).
Software	Must be unchanged from the predicate device's proprietary manufacturing software.	"There are no changes in the software compared to the existing 3M Clarity Aligners (K192119)."
Optical Properties	Must meet predefined standards for clarity, transparency, or other relevant optical attributes for clear aligners.	"Results of optical properties... are included in this Premarket submission which showed acceptable results for all tested samples."
Mechanical Stability	Must demonstrate sufficient strength, durability, and resistance to deformation under typical use conditions.	"Results of... mechanical stability... are included in this Premarket submission which showed acceptable results for all tested samples."
Staining Resistance	Must resist common staining agents encountered during oral use to maintain aesthetic appearance.	"Results of... staining... are included in this Premarket submission which showed acceptable results for all tested samples."
Transportation Stability	Must withstand typical shipping and handling conditions without degradation.	"Results of... transportation... are included in this Premarket submission which showed acceptable results for all tested samples."
Use Life (Durability)	Must maintain performance and integrity throughout the prescribed wear period.	"Results of... use life... are included in this Premarket submission which showed acceptable results for all tested samples."
Force Application	Must consistently apply forces necessary for programmed tooth movement, comparable to the predicate device.	"Results of... force... are included in this Premarket submission which showed acceptable results for all tested samples." While the material is different, the "Technical Features and Properties" section states "No change" implying similar force application principles.
Conditioning	Must retain properties after exposure to environmental conditions (e.g., temperature, humidity) throughout its lifecycle.	"Results of... conditioning among others are included in this Premarket submission which showed acceptable results for all tested samples."
Biocompatibility	Must be safe for mucosal membrane contact for greater than 30 days, adhering to relevant FDA guidelines.	"The biocompatibility evaluation for the device was conducted in accordance with US FDA Docket Number FDA-2013-D-0350 edition dated: September 4, 2020. The aligner is considered mucosal membrane contacting device that is intended to be in contact with the body for greater than 30 days. The evaluation found this product to be safe for its intended use."

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.

Summary

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March 3, 2022

3M Company, Unitek Orthodontic Products % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K211190

Trade/Device Name: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC

Dear Prithul Bom:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated April 23, 2021. Specifically, FDA is updating this SE Letter for a typo in the trade name as an administrative correction

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Michael Adjodha, OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices, 301-796-6276, Michael.adjodha@fda.hhs.gov.

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 23, 2021

3M Company, Unitek Orthodontic Products % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K211190

Trade/Device Name: 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Fix) Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: April 20, 2021 Received: April 21, 2021

Dear Prithul Bom:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K211190

Device Name

3M TM Clarity TM Aligners (3M TM Clarity TM Aligners-Force, 3M™ Clarity TM Aligners-Flex)

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

3M™ Clarity™ Aligners (Force and Flex)

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510(k) Summary

This 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Submitter	3M CompanyUnitek Orthodontic Products2510 Conway AvenueSt. Paul, MN 55144Establishment Registration No.: 2110898
Primary Contact	Yanine Garcia-QuezadaRegulatory AffairsPhone: (651) 736-8238Fax: (651) 736-1599ygarcia-quezada@mmm.com
Secondary Contact	Brendan Casey, Ph.D.Regulatory Affairs ManagerPhone: (651) 737-4488Fax: (651) 736-1599bcasey@mmm.com
Submission Date	7 April 2021
Proprietary Trade Name	3M™ Clarity™ Aligners
Device Name	Aligner
Common Name	Sequential Aligner
Classification Name	Orthodontic Plastic Bracket
Regulation Number	21 CFR 872.5470
Product Code	NXC
Classification Panel	Dental Products Panel 76

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Indications for Use:

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

Predicate Devices:

3M Clarity Aligners (K192119)

Description of Device:

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Technological Characteristics:

3M Clarity Aligners-Flex and the previously cleared 3M Clarity Aligners (K192119) have the same design, device features, software as well as their manufacturing processes.

Performance Testing:

Results of optical properties, mechanical stability, staining, transportation, use life, force, conditioning among others are included in this Premarket submission which showed acceptable results for all tested samples.

Software

There are no changes in the software compared to the existing 3M Clarity Aligners (K192119).

Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with US FDA Docket Number FDA-2013-D-0350 edition dated: September 4, 2020. The aligner is considered mucosal membrane contacting device that is intended to be in contact with the body for greater than 30 days. The evaluation found this product to be safe for its intended use.

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Feature	Predicate Device:3M™ Clarity™ Aligner	Proposed Device:3M™ Clarity™ Aligner-Flex
Manufacturer	3M Company2510 Conway AvenueSt. Paul, MN 55144	3M CompanyUnitek Orthodontic Products2510 Conway AvenueSt. Paul, MN 55144
510(k) Number	K192119	To be determined
RegulationNumber	21 CFR 872.5470	No change
Product Code	NXC	No change
Device Class	Class II	No change
Indications forUse:	3M Clarity Aligners are indicated forthe alignment of teeth duringorthodontic treatment ofmalocclusion.	Clarity Aligners are indicated forthe alignment of teeth duringorthodontic treatment ofmalocclusion.
ManufacturingProcess	Aligners are manufactured using anautomated state of the art process.	No change
Material	3M Force Thermoplastic Material	3M Flex Thermoplastic Material
TechnicalFeatures andProperties	Orthodontic tooth movements occurthrough forces applied to thedentition as each tooth follows theprogrammed displacement based on adoctor's prescription.	No change
Software	Proprietary software is used in themanufacturing process of thecurrently commercialized aligners.	No change

Substantial Equivalence Comparison

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Substantial Equivalence Conclusion:

The 3M Clarity Aligners-Flex and the previously cleared 3M Clarity Aligners (K192119) have the same indications for use, same manufacturing processes, same design, and same device features and are considered substantially equivalent (21 CFR 807.100).

Regulation Number and Section

§ 872.5470 Orthodontic plastic bracket.

(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.