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.

AI/ML Overview

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).

Feature / Criteria (for this submission K183159)	Reported Device Performance (3M Clarity Aligners)
Indications for Use (Expansion)	Expanded to "alignment of teeth during orthodontic treatment of malocclusion," removing the previous limitation of "patients with permanent dentition (i.e., all second molars)." This matches the primary predicate Invisalign.
Technological Characteristics	Identical to the previously cleared 3M Clear Tray Aligner (K163689). This includes design, material composition, device features, and manufacturing processes.
Material Composition	Thermoplastic, identical to 3M Clear Tray Aligner (K163689). Different from primary predicate Invisalign, but considered equivalent due to previous clearance of K163689.
Software	No changes compared to existing 3M Clarity Aligners; design, development, methodology, process, and environment are identical to the predicate device.
Biocompatibility	Previously tested and reviewed for K163689.
Performance Testing	Previously tested and reviewed for K163689.
Software Verification & Validation	Previously tested and reviewed for 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.

Summary

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November 26, 2018

Image /page/0/Picture/1 description: The image contains 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' in a larger, bold blue font, with the word 'ADMINISTRATION' underneath in a smaller font.

3M Company % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K183159

Trade/Device Name: 3M Clarity Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: November 13, 2018 Received: November 15, 2018

Dear Mark Job:

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/cfpmp/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.

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Digitally signed by Mary S. Mary 3. S. - Mary S. Runner -S3
Runner -S3 - 13:11:50 -05:00

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4

Indications for Use Statement

3M™ Clarity™ Aligners

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

Device Name

3M™ Clarity™ Aligners

Indications for Use (Describe)

3MIM Clarity M 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (7/17)

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Section 3

510(k) Summary

3M™ Clarity™ Aligners

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510(k) Summary

Image /page/5/Picture/3 description: The image shows the 3M logo. The logo is red and features the number "3" followed by the letter "M". The "3" is larger than the "M". The logo is simple and recognizable.

510(k) Summary

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

510(k) Submitter	3M Company, 3M Health Care2510 Conway AvenueSt. Paul, MN 55144Owner/Operator No.: 2110898Establishment Registration No.: 2110898
Primary Contact	Yanine Garcia-QuezadaRegulatory AffairsPhone: (651) 736-8238Fax: (651) 736-1599ygarcia-quezada@mmm.com
Secondary Contact	Mark BurvilleRegulatory Affairs ManagerPhone: (651) 737-2027Fax: (952) 918-5242mcburville@mmm.com
Submission Date	08 November 2018
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
Classification	Medical Device, Class II

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Indications for Use:

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

Predicate Devices:

Invisalign® System (K081960) [Primary Predicate] 3M Clear Tray Aligner (K163689) [Predicate Device]

Description of Device:

3M Company, 3M Health Care is submitting this 510(k) Premarket Notification because the Indications for Use are changing with the removal of the treatment limitation of patients with permanent dentition (i.e., all second molars). The updated indications for use are the same as the primary predicate Invisalign. Both devices are indicated for the correction of malocclusions. Neither of the indications specify the types of tooth movement to be used.

The change in indications for use to remove specific tooth movement types for the 3M Clarity Aligners does not affect the design, material composition, manufacturing processes and related software, these remain the same as the cleared 3M Clear Tray Aligner (K163689). There are no changes to the current contraindications. There is the addition of a precaution addressing the need to wear gloves when handling adhesives, and the expansion of one note where examples have been added as the original note did not include examples of supplemental treatments. Warning and precautions associated with the use of attachments, and one warning associated with the use of aligner tools to seat and/or remove aligners were also added.

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Technological Characteristics:

The material composition of the 3M Clarity Aligners is different from the material composition of the primary predicate Invisalign System. However, the material composition remains identical to the previously cleared 3M Clear Tray Aligner (K163689). The 3M Clarity Aligners and the previously cleared 3M Clear Tray Aligner have the same technological characteristics, such as design, material composition, device features, as well as their manufacturing processes.

Software

There are no changes in the software compared to the existing 3M Clarity Aligners. The software design and development, software development methodology, software development process and environment are identical for the existing predicate device and the modified 3M Clarity Aligners.

Testing

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.

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Substantial Equivalence Comparison

The following table compares the 3M Clarity Aligners to the primary predicate device Invisalign System, and to the predicate device 3M Clear Tray Aligner with respect to intended use, technological characteristics and principles of operation.

Table #1

Feature	Invisalign® System(Primary Predicate)	3M™ Clear TrayAligner(Predicate Device)	3M™Clarity™ Aligners
510(k) Number	K081960	K163689	To be determined
Manufacturer	Align Technology, Inc.	3M Company, 3M Unitek	3M Company, 3M HealthCare
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470
DeviceClassificationName	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket
Product Code	NXC	NXC	NXC
Device Class	Class II	Class II	Class II
Indications forUse	The Invisalign System isindicated for the alignment ofteeth during orthodontictreatment of malocclusion.	The 3M Clear Tray Alignersystem is a series of clear,lightweight, plasticappliances indicated for thetreatment of toothmalocclusions in patientswith permanent dentition(i.e., all second molars).Utilizing a series ofincremental toothmovements, it sequentiallypositions teeth by way ofcontinuous gentle force.	3M Clarity Aligners areindicated for the alignment ofteeth during orthodontictreatment of malocclusion.
Mode ofAction	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.
Material	Thermoplastic	Thermoplastic	Thermoplastic
Software Usedfor OrderingWorkflow	Yes	Yes	Yes

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Feature	Invisalign® System(Primary Predicate)	3M™ Clear TrayAligner(Predicate Device)	3M™Clarity™ Aligners
Design	Image: Invisalign aligner	Image: 3M Clear Tray Aligner	Image: 3M Clarity Aligners

Substantial Equivalence Conclusion:

3M Clarity Aligners are substantially equivalent to the predicate device Invisalign cleared under K081960 in that both systems have the same indications for use. This premarket notification is being submitted to expand the indications for use and to update labeling. There are no changes in the technological characteristics, design, material composition, device features to the previously cleared 3M Clear Tray Aligner (K163689).

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.