The 3MM Clear Tray Aligner system is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.

Device Description

The 3M Clear Tray Aligner System is 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 the 3M Clear Tray Aligner system 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 travs 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 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

The provided text describes the 3M™ Clear Tray Aligner and its substantial equivalence to predicate devices, but it does not contain information about specific acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical trial report or performance study for a diagnostic or AI-driven device.

The document is a 510(k) summary for a medical device, focusing on demonstrating substantial equivalence to already marketed predicate devices (Invisalign® System and ClearCorrect System) rather than presenting a performance study with detailed acceptance criteria for a novel AI or diagnostic algorithm.

Here's a breakdown of why this information is not present in the provided text, and what is available:

1. A table of acceptance criteria and the reported device performance:

Not Available: The document does not provide a table of acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for device performance in the context of an AI or diagnostic tool.
What is available: The document focuses on demonstrating that the 3M™ Clear Tray Aligner is "as safe, as effective, and is substantially equivalent" to predicate devices based on:
- Shared indications for use.
- Similar technological characteristics (thermoplastic material, incremental tooth movement principle).
- Similar mechanism of action.
- Bench testing for material properties (translucency, shelf life, life expectancy) which showed "acceptable" properties.
- Biocompatibility testing (cytotoxicity, sensitization, irritation) which "met the requirements of the study protocols" and found the material "non-cytotoxic, non-sensitizing and is not an intracutaneous irritant."
- Software verification and validation for the ordering and processing software, which was considered "moderate" level of concern.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

Not Available: There is no mention of a "test set" in the context of evaluating an AI or diagnostic algorithm's performance. The document describes testing of the physical material and software, not an algorithm's diagnostic accuracy on a dataset.

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 Available: Not applicable, as there's no mention of a test set requiring expert-established ground truth for an AI or diagnostic assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not Available: Not applicable for the same reason as above.

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 Available: The device is a physical orthodontic aligner system, not an AI or diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant to this submission.

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

Not Available: The device is a physical product. While it uses software for ordering and design, the submission does not perform a standalone performance evaluation of a diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Available: Ground truth, in the context of AI/diagnostic evaluation, is not mentioned. The "ground truth" for the material and software testing would be established by the specifications of those tests (e.g., chemical composition standards for biocompatibility, functional requirements for software).

8. The sample size for the training set:

Not Available: Not applicable, as there is no AI model or algorithm being "trained" in the sense of machine learning for diagnostic purposes. The software mentioned facilitates ordering and processing, but it's not described as an AI algorithm that learns from a training set.

9. How the ground truth for the training set was established:

Not Available: Not applicable for the same reason as above.

In summary: The provided document is a 510(k) premarket notification for a physical medical device (orthodontic aligners). Its purpose is to demonstrate substantial equivalence to existing devices through comparisons of indications for use, technology, materials, and limited bench and biocompatibility testing. It does not describe an AI or diagnostic algorithm, nor does it present a study with performance-based acceptance criteria typical for such technologies.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three human profiles facing right, layered on top of each other to create a sense of depth and unity. The profiles are connected by flowing lines, suggesting movement and progress.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 27, 2017

3MTM Unitek Corporation c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, New York 55313

Re: K163689

Trade/Device Name: 3M™ Clear Tray Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: October 7, 2016 Received: December 28, 2016

Dear Mr. 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. 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 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 (reporting of medical

{1}------------------------------------------------

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael J. Ryan -S

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

3MTM Clear Tray Aligner

Indications for Use (Describe)

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 (8/14)

{3}------------------------------------------------

510(k) Summary 3M Unitek

510(k) Summary

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

510(k) Submitter	3M Unitek Corporation2724 South Peck RoadMonrovia, CA 91016-5097Owner/Operator No.: 2110898Establishment Registration No.: 2020467
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	07 October 2016
Proprietary Trade Name	To be Determined
Device Name	3M™ Clear Tray 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

{4}------------------------------------------------

Indications for Use:

The 3M Clear Tray Aligner System is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e. all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.

Predicate Devices:

Invisalign® System (K081960) [Primary Predicate] ClearCorrect System (K113618) [Predicate Device]

Description of Device:

{5}------------------------------------------------

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.

The technology is essentially identical to that used by a number of sequential aligner systems including the predicates referenced in Table #1.

Technological Characteristics:

Treatment of tooth malocclusions via a series of plastic appliances that incrementally moves teeth to a desired end-state is the technological principle for both the subject and predicate devices. A comparison between the technological characteristics of the 3M Clear Tray Aligner and that of legally marketed predicate devices has been performed. The results of this comparison demonstrate that the design, technology, materials and composition of the 3M Clear Tray Aligner are substantially equivalent to the predicate devices.

Mechanism of Action:

The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence. Orthodontic tooth movement occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental health professional's prescription.

Performance Testing

Although, bench testing was not performed due to the difficulty in evaluating this type of dental device in a laboratory setting: translucency testing, shelf life and life expectancy tests were conducted on the thermoformed tray material which showed acceptable translucency properties and shelf life requirements for all tested samples.

There is sufficient information available from the scientific literature and from the predicate devices to demonstrate that sequential aligners provide reasonable assurance of safety and effectiveness.

{6}------------------------------------------------

Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with the US FDA Docket Number FDA-2013-D-0350. CDRH Document Number 1811 "Use of International Standard ISO 10993-1. Biological evaluation and testing within a risk management process -Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The battery of testing included the following tests:

Cytotoxicity .
Sensitization .
Irritation ●

The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.

Software Verification and Validation Testing

Software verification and validation testing were conducted on the software that facilitates ordering and processing of the 3M Clear Tray Aligner to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

{7}------------------------------------------------

Substantial Equivalence Comparison

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

Table #1

Feature	3MTMClear Tray Aligner	Invisalign® System(Primary Predicate)	ClearCorrect System(Predicate Device)
510(k) Number	To be determined	K081960	K113618
Manufacturer	3M Unitek	Align Technology, Inc.	ClearCorrect LLC
RegulationNumber	21 CFR 872.5470	21 CFR 872.5470	21 CFR 872.5470
DeviceClassificationName	Orthodontic Plastic Bracket	Orthodontic PlasticBracket	Orthodontic Plastic Bracket
Product Code	NXC	NXC	NXC
Device Class	Class II	Class II	Class II
Indications forUse	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.	The Invisalign System isindicated for the alignmentof teeth during orthodontictreatment of malocclusion.	The ClearCorrect System isindicated for the treatment oftooth malocclusion inpatients with permanentdentition (i.e. all secondmolars). The ClearCorrectSystem positions teeth byway of continuous gentleforce.
Mode ofAction	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentitionas each tooth follows theprogrammed displacementbased on a doctor'sprescription	Orthodontic tooth movementoccurs through forces appliedby the appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription
Material	Thermoplastic	Thermoplastic	Thermoplastic
MaterialProperties	Demonstrates sufficienttensile strength, elasticity,ductility, chemical resistance,and clarity for use as a cleartray aligner.	Demonstrates sufficienttensile strength, elasticity,ductility, chemicalresistance, and clarity foruse as a clear tray aligner.	Demonstrates sufficienttensile strength, elasticity,ductility, chemical resistance,and clarity for use as a cleartray aligner.
Feature	3M™Clear Tray Aligner	Invisalign® System(Primary Predicate)	ClearCorrect System(Predicate Device)
Software Used for OrderingWorkflow	Yes	Yes	Yes
Design	Image: 3M Clear Tray Aligner	Image: Invisalign System	Image: ClearCorrect System

{8}------------------------------------------------

Substantial Equivalence Conclusion:

The Clear Tray Aligner has substantially equivalent Indications for Use as the identified predicate devices. The verbiage of the Indications of Use of the subject device is slightly different than the declared predicates; however, these slight differences do not alter the intended therapeutic use of the device as compared to the predicates.

The conclusions drawn from the data included in this submission, demonstrates that the 3M Clear Tray Aligner is as safe, as effective, and is substantially equivalent to the predicate devices in indications for use, design, technological characteristics, mechanism of action, performance, materials 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.