ClearCorrect System by ClearCorrect, LLC

The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks. The corrective forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the appliance. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply forces in directions that cannot be achieved by engaging with tooth surfaces alone.

AI/ML Overview

The provided FDA 510(k) summary (K220140) for ClearCorrect System does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the format requested.

Specifically, it lacks:

A table of acceptance criteria and the reported device performance. While "Performance Data" is listed, it only mentions types of tests conducted (e.g., package integrity, biocompatibility, tensile performance, etc.) but does not provide specific acceptance criterion values or the results obtained from these tests.
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 their qualifications.
Adjudication method for the test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size.
If a standalone (algorithm only without human-in-the-loop performance) was done.
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 primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use, technological characteristics (mode of action, materials, sterilization, use, packaging, and treatment planning software), and general performance data types. It states that performance data was generated but does not present the detailed results or the methodology in the way requested for a typical AI/medical imaging device submission.

It explicitly lists the following performance data categories:

Package integrity via simulated transport test per ISTA 2A
Validation of shelf life per ASTM F1980
Biocompatibility per the ISO 10993 series standards
Water absorption testing per ISO 62
Tensile performance testing per ISO 527-3
Flexural performance testing per ISO 178
Impact performance testing per ISO 8256
Tear resistance testing per ISO 6383-1
Fatigue resistance testing per ASTM D7774
Stress relaxation testing
Dimensional stability per internal methods
Usability testing per IEC 62366-1
Software development per IEC 62304

However, for each of these, the specific acceptance criteria and the numerical results demonstrating that the device meets those criteria are not detailed in this summary.

Summary

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

October 5, 2022

ClearCorrect, LLC Christopher Klaczyk VP, Head of Regulatory Affairs 21 Cypress Boulevard, Suite 1010 Round Rock, Texas 78665

Re: K220140

Trade/Device Name: ClearCorrect System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 8, 2022 Received: September 9, 2022

Dear Christopher Klaczyk:

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.

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

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

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 (OS) 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, 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

Enclosure

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

Indications for Use

510(k) Number (if known) K220140

Device Name ClearCorrect System

Indications for Use (Describe)

The Clear Correct System is indicated for the alignment of teeth during orthodontic treatment of tooth 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."

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

510(k) Summary	K220140
Submitter:	ClearCorrect, LLC21 Cypress BoulevardSuite 1010Round Rock, TX 78665
Contact Person:	Christopher KlaczykHead of Regulatory Affairs+1 (512) 831-5128christopher.klaczyk@clearcorrect.com
Date Prepared:	October 1, 2022
Product Code(s):	NXC (21 CFR 872.5470)
Device Class:	II (21 CFR 872.5470)
Classification Panel:	Dental Devices (DHT1B)
Classification Name:	Orthodontic plastic bracket (21 CFR 872.5470)
Common Name	Aligner, Sequential
Proprietary Name:	ClearCorrect System
Predicate Device(s):	K143630, Invisalign System, Align Technologies
Reference Device(s):	K210320, ClearCorrect System, ClearCorrect, LLCK203737, Spark Clear Aligner System, Ormco Corporation
Device Description:	The aligners of the ClearCorrect System are a sequentialseries of clear thermoformed orthodontic appliances that,when worn in the prescribed sequence and duration,progressively reposition the teeth. The aligner is anorthodontic appliance intended for intra-oral use. Individualdevices will be used between 20 – 22 hours per day for aperiod ranging from one to three weeks. The correctiveforces to align teeth are primarily generated by the differencebetween the starting tooth position and the planned toothposition defined by the appliance. Features can be added tothe aligner that engage with composite resin toothattachments to improve aligner retention and/or to apply force sin directions that cannot be achieved by engaging with toothsurfaces alone.
Indications For Use:	The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion.
Materials:	The ClearCorrect aligners are produced from multi-layer polymer film having the trade name ClearQuartz™. The film consists of one layer of elastomeric polyurethane sandwiched between two layers of rigid co-polyester.
Technological Characteristics:	A comparison of the indications and relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows.
Performance Data:	Package integrity via simulated transport test per ISTA 2A Validation of shelf life per ASTM F1980 Biocompatibility per the ISO 10993 series standards Water absorption testing per ISO 62 Tensile performance testing per ISO 527-3 Flexural performance testing per ISO 178 Impact performance testing per ISO 8256 Tear resistance testing per ISO 6383-1 Fatigue resistance testing per ASTM D7774 Stress relaxation testing Dimensional stability per internal methods Usability testing per IEC 62366-1 Software development per IEC 62304
Conclusions:	The Indications for Use and the technological characteristics of the subject device are largely the same as the primary predicate device. The material of construction and the treatment planning software are identical to the reference predicate device. The subject devices have been determined to be substantially equivalent to the identified predicate devices.

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

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

Feature	Subject DeviceClearCorrect System	Primary Predicate DeviceInvisalign System(K143630)	Reference DeviceClearCorrect System(K210320)	Reference DeviceSpark Clear Aligner Sys.(K203737)	Equivalence Discussion
Indicationsfor Use	The ClearCorrect System isindicated for the alignmentof teeth during orthodontictreatment of toothmalocclusion.	The Invisalign System isindicated for the alignmentof teeth during orthodontictreatment of malocclusion.	The ClearCorrect System isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e. all secondmolars). The ClearCorrectSystem positions teeth byway of continuous gentleforce.	The Spark™ Clear AlignerSystem is indicated for thealignment of teeth duringorthodontic treatment ofmalocclusion.	EquivalentThe indication for theSubject Device is a subsetof the indications for thePrimary Predicate Device.And the K203737Reference Predicate Device.
Mode ofAction /OperatingPrinciple	The aligner is anorthodontic applianceintended for intra-oral use.Individual devices will beused between 20 – 22 hoursper day for a period rangingfrom one to three weeksThe corrective forces toalign teeth are primarilygenerated by the differencebetween the starting toothposition and the plannedtooth position defined bythe tray. Features can beadded to the aligner thatengage with composite resintooth attachments toimprove aligner retentionand/or to apply force indirections that cannot beachieved by engaging withtooth surfaces alone.	The corrective forces toalign teeth are primarilygenerated by the differencebetween the starting toothposition and the plannedtooth position defined bythe tray.	The aligner is anorthodontic applianceintended for intra-oral use.Individual devices will beused between 20 – 22 hoursper day for a period rangingfrom one to three weeksThe corrective forces toalign teeth are primarilygenerated by the differencebetween the starting toothposition and the plannedtooth position defined bythe tray. Features can beadded to the aligner thatengage with composite resintooth attachments toimprove aligner retentionand/or to apply force indirections that cannot beachieved by engaging withtooth surfaces alone.	Orthodontic toothmovement occurs throughforces applied by theappliance to the dentition aseach tooth follows theprogrammed displacementbased on a doctor'sprescription.	EquivalentThe mode of operation ofthe Subject Device islargely equivalent to that ofthe Primary PredicateDevice and is identical tothat of the K210320Reference Predicate Device.
Feature	Subject DeviceClearCorrect System	Primary Predicate DeviceInvisalign System(K143630)	Reference DeviceClearCorrect System(K210320)	Reference DeviceSpark Clear Aligner Sys.(K203737)	Equivalence Discussion
AlignerMaterial	Thermoplasticpolyurethane-polyestercomposite resin, tradenameClearQuartz	Thermoplastic polymer	Thermoplasticpolyurethane-polyestercomposite resin, tradenameClearQuartz	Thermoplasticpolyurethane-polyestercomposite resin, tradenameTruGEN	IdenticalThe Subject Alignermaterial is identical to thatof the Reference Devicesper K210320 and K203737.
Sterilization	Provided in non-sterilecondition. Not intended tobe sterilized before use.	Provided in non-sterilecondition. Not intended tobe sterilized before use.	Provided in non-sterilecondition. Not intended tobe sterilized before use.	Provided in non-sterilecondition. Not intended tobe sterilized before use.	IdenticalThe status of the Subjectdevices is identical to thatof the Reference Device perK210320.
Singe Use/Reuse	Repeated use by a singlepatient	Repeated use by a singlepatient	Repeated use by a singlepatient	Repeated use by a singlepatient	IdenticalThe use profile of theSubject devices is identicalto that of the ReferenceDevice per K210320.
Packaging	Primary: LDPE bagcontaining one or twoappliances as defined by theprescribed treatment plan.Secondary: 20 pt C1S SBSpaperboard box	Unknown	Primary: LDPE bagcontaining one or twoappliances as defined by theprescribed treatment plan.Secondary: 20 pt C1S SBSpaperboard box	Unknown	IdenticalThe packaging for theSubject devices is identicalto that of the ReferenceDevice per K210320.
Feature	Subject DeviceClearCorrect System	Primary Predicate DeviceInvisalign System(K143630)	Reference DeviceClearCorrect System(K210320)	Reference DeviceSpark Clear Aligner Sys.(K203737)	Equivalence Discussion
TreatmentPlanningSoftwareDescription	ClearCorrect techniciansusing the ClearCorrect Cutand Stage software use ascan of a PVS impression orthe output of an intra-oralscanner of the patient'suntreated oral anatomy andthe prescription details toderive the desired finalpatient tooth positions.Using this desired state, thesoftware interprets a seriesof intermediate states thatadhere to defined maximumtooth motions and clinicianinstructions. The technicianfurther refines theseintermediate statesmanually as necessary tofacilitate the desiredoutcome. The dentalpractitioner then reviewsthese images and has theoption to reject or requestmodifications to the set-upprior to approving it foraligner fabrication. Once thedental practitioner approvesthe treatment plan, thesoftware converts the filesto produce the series ofcustom-made aligners	The Align 3-D Softwareuses a scan of a PVSimpression or a digital scan(which represents anuntreated state) to generatethe image of a final, treatedstate and then interprets aseries of images thatrepresent intermediate teethstates. The dentalpractitioner then reviewsthese images and has theoption to reject or requestmodifications to the set-upprior to approving it foraligner fabrication. Once thedental practitioner approvesthe treatment plan, thesoftware converts the filesto produce the series ofcustom-made aligners	ClearCorrect techniciansusing the ClearCorrect Cutand Stage software use ascan of a PVS impression orthe output of an intra-oralscanner of the patient'suntreated oral anatomy andthe prescription details toderive the desired finalpatient tooth positions.Using this desired state, thesoftware interprets a seriesof intermediate states thatadhere to defined maximumtooth motions and clinicianinstructions. The technicianfurther refines theseintermediate statesmanually as necessary tofacilitate the desiredoutcome. The dentalpractitioner then reviewsthese images and has theoption to reject or requestmodifications to the set-upprior to approving it foraligner fabrication. Once thedental practitioner approvesthe treatment plan, thesoftware converts the filesto produce the series ofcustom-made aligners	The Spark™ Clear AlignerSystem 3-D software usesscanned teeth data,landmarks and theclinician's prescription todesign a corrected casesetup for the clinician'sreview. The output filesfrom this software are sentto the clinician, who maysuggest improvements orapprove as-is formanufacture. The softwareis used to produce pre-molds and molds needed forthe manufacturing of seriesof custom-made aligners.	IdenticalThe software used bytechnicians internal toClearCorrect is identical tothat used with the ReferencePredicate Device.The software is functionallyequivalent to the softwareof the Primary Predicate.
Feature	Subject DeviceClearCorrect System	Primary Predicate DeviceInvisalign System(K143630)	Reference DeviceClearCorrect System(K210320)	Reference DeviceSpark Clear Aligner Sys.(K203737)	Equivalence Discussion
ClinicianInterfaceSoftwareDescription	The ClearCorrect DoctorPortal is used by theclinician to initiate newtreatment cases coordinatingthe provision of dentalrecords, the prescription,and any other treatmentinstructions. Doctor Portalalso allows the clinician tomanage existing cases andaddress any actionsassociated with those cases.The ClearCorrectClearPilot™ allows theclinician to view, commentand approve the orthodontictreatment plan. ClearPilotalso allows the clinician tomonitor treatment progressagainst the plan and to sharethe plan with the patient.	ClinCheck Software is anelectronic prescription formand process used to depict,edit, view, monitor andapprove an orthodontictreatment plan.Treatment Plan File:The plan downloads toother computing devices(e.g., tablets)The plan is deleted uponexiting application	The ClearCorrect DoctorPortal is used by theclinician to initiate newtreatment cases coordinatingthe provision of dentalrecords, the prescription,and any other treatmentinstructions. Doctor Portalalso allows the clinician tomanage existing cases andaddress any actionsassociated with those cases.The ClearCorrect ClearPilotallows the clinician to view,comment and approve theorthodontic treatment plan.ClearPilot also allows theclinician to monitortreatment progress againstthe plan and to share theplan with the patient.	Unknown	EquivalentThe combination of Subjectdevice clinician interfacesoftware provides the samefunctionality as the PrimaryPredicate Device ClinChecksoftware and is identical tothat of the ReferenceDevice.

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

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

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

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.