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).

AI/ML Overview

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:

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

Summary

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September 5, 2019

3M Company % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K192119

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: August 5, 2019 Received: August 6, 2019

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 medical devices and radiation-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.

for Michael Adjodha Acting Assistant Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 08/30/2020 See PRA Statement below.

510(k) Number (if known)
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K192119

Device Name

3Mm Clarity TM Aligners

Indications for Use (Describe)

3MM 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

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510(k) Summary

K192119

C. N

510(k) Summary

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

510(k) Submitter	3M Company2510 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	24 May 2019
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:

3M Clarity Aligners (K183159) [Primary Predicate Device]

Description of Device:

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

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indications for use. The present premarket submission is to account for the overall software cumulative changes including the integration of the ULab software (K171295).

Technological Characteristics:

The modified 3M Clarity Aligners and the previously cleared 3M Clarity Aligners (K183159) have the same technological characteristics, such as design, material composition, device features, as well as their manufacturing processes.

Performance Testing:

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.

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Substantial Equivalence Comparison
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	Primary Predicate Device:	Proposed Device:	Comparison:
	3MTM ClarityTM Aligners(K183159)	3MTM ClarityTM Aligners
Indicationsfor Use	3M Clarity Aligners areindicated for the alignment ofteeth during orthodontictreatment of malocclusion	3M Clarity Aligners are indicatedfor the alignment of teeth duringorthodontic treatment ofmalocclusion	Identical
SoftwareDescription	The Oral Care Portal implements3M Clarity Aligners orderingand review/approval process.Doctors may submit ordersthrough the Order Wizard. Themodel is then manipulatedoutside of the system for thefinal occlusion based on thecharacteristics in the submittedorder. This setup model is sentback to the system for the doctorto review, and subsequentlyapproved or rejected. If thedoctor rejects the model, theprocess is repeated until thedoctor approves the model.	The Oral Care Portal implements3M Clarity Aligners ordering andreview/approval process. Doctorsmay submit orders through theOrder Wizard. The model is thenmanipulated outside of the systemfor the final occlusion based onthe characteristics in thesubmitted order. This setupmodel is sent back to the systemfor the doctor to review, andsubsequently approved orrejected. If the doctor rejects themodel, the process is repeateduntil the doctor approves themodel.	Identical
Mode ofOperation	Oral Care Portal softwareperforms the followingoperations:-Produce 3D model file of adigital scan or from a PVSimpression model-Identifies individual teeth thatwill require treatment-Creates a treatment plan-Communicates with DentalHealth Professional wheretreatment plan is reviewed, ifmodifications are requestedthese are applied prior toapproval.	Oral Care Portal softwareperforms the followingoperations:-Produce 3D model file of adigital scan or from a PVSimpression model-Identifies individual teeth thatwill require treatment-Creates a treatment plan-Communicates with DentalHealth Professional wheretreatment plan is reviewed, ifmodifications are requested theseare applied prior to approval.	Identical
SoftwareElements	An electronic description formand process used to depict, edit,view, monitor and approve anorthodontic treatment plan	An electronic description formand process used to depict, edit,view, monitor and approve anorthodontic treatment plan	Identical
	Treatment Plan:	Treatment Plan:	Identical
Software Elements	-Dental Health Professionalaccesses 3M OCP web-basedapplication-Treatment plan is created andsubmitted to 3M	-Dental Health Professionalaccesses 3M OCP web-basedapplication-Treatment plan is created andsubmitted to 3M
SoftwareElements-ULab	Set Up Record Treatment Plan:-Dental Health Professionalaccesses 3M OCP web-basedapplication and finds ULab icon-Dental Health Professionalsigns into ULab software-Treatment plan is created andsubmitted to 3M-3M creates treatment plan basedon ULab setup record-3M and Dental HealthProfessional interact until designtreatment is approved	Full Treatment Plan:-Dental Health Professionalaccesses 3M OCP web-basedapplication and finds ULab icon-Dental Health Professional signsinto ULab software-Treatment plan is created andsubmitted to 3M-3M manufactures alignersNote: there are no records QC orsetup review steps in the process.The order goes directly toproduction software	Proposed software includesULab treatment plan thateliminates the interactionwith 3M technicians. TheDental Health Professionalowns the treatmentplanning process andsubmits directly to 3M formanufacturingNote: both ULab Set UpRecord and Full Treatmentplans are available. TheDental Health Professionalchooses which ULab planto use

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Substantial Equivalence Conclusion:

The 3M Clarity Aligners are substantially equivalent to the primary predicate device (21 CFR 807.100). The 3M Clarity Aligners are identical in all aspects to the primary predicate, other than software improvements and the integration of the ULab software. 3M Clarity Aligners are as safe, as effective, and substantially equivalent to the predicate device in terms of intended use, indications for use, design, performance, technological characteristics, mechanism of action, composition and biocompatibility.

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.