ClearCorrect System by ClearCorrect LLC

The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.

Device Description

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 force to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force in directions that cannot be achieved by engaging with tooth surfaces alone.

The retainers of the ClearCorrect System are clear thermoformed appliances intended to keep the teeth from relapsing after they have been treated with aligners. Retainers are an optional component of aligner therapy. Retainers are typically prescribed for use at the conclusion of aligner treatment but can be prescribed at other times should there be a need to interrupt aligner treatment.

The engager templates of the ClearCorrect System are clear thermoformed appliances used to accurately apply composite resin attachments to the teeth as needed to achieve the desired tooth movement. The use of engagers and engager templates is an optional component of aligner treatment. Cavities are formed in the film having the desired shape, orientation and tooth position of the engager attachments to be bonded to the patient's teeth. At the time of use, the clinician fills the cavities in the engager template with light-curing composite resin. The engager template is then placed onto the patient's teeth and the resin cured. Once the resin is cured, the engager template is removed and discarded.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for the ClearCorrect System, an orthodontic device. While it details the device's indications for use, materials, and a comparison to predicate devices, it does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes for training/test sets, expert qualifications, or MRMC studies.

Instead, the "Performance Data" section lists various types of studies conducted to establish substantial equivalence (e.g., package integrity, shelf life, biocompatibility, material property testing, usability, software development). It states that these studies were used to demonstrate substantial equivalence, but it does not provide the results of these studies nor does it define acceptance criteria for these studies.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance.
Sample sized 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, and its effect size.
If a standalone study 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 establishing substantial equivalence to existing predicate devices based on technological characteristics and general performance testing, rather than reporting on a clinical or performance study with defined acceptance criteria and detailed methodology for AI/software performance.

Summary

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August 6, 2021

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

Re: K210320

Trade/Device Name: ClearCorrect System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 3, 2021 Received: May 5, 2021

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

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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

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Indications for Use

510(k) Number (if known) K210320

Device Name ClearCorrect System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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5.	510(k) Summary	K210320
	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:	July 30, 2021
	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):	K113618, ClearCorrect System, ClearCorrect LLC
	Reference Device(s):	K182826, Ormco™ Spark™ Aligner System, Sybron DentalSpecialties
	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 corrective forceto align teeth are primarily generated by the differencebetween the starting tooth position and the planned toothposition defined by the tray. Features can be added to thealigner that engage with composite resin tooth attachments toimprove aligner retention and/or to apply force in directionsthat cannot be achieved by engaging with tooth surfaces

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Image /page/4/Picture/3 description: The image shows a clear aligner on a pink background. The aligner is a dental device used to straighten teeth. It is made of clear plastic and is designed to fit over the teeth. The aligner is custom-made for each patient and is worn for a specific period of time. The pink background is a solid color and provides a contrast to the clear aligner.

Picture of Device

Indications For Use:

Materials:

The ClearCorrect aligners are produced from multi-laver polymer film having the trade name ClearQuartz™. The film consists of one laver of elastomeric polyurethane sandwiched between two-layers of rigid co-polyester.

The ClearCorrect System is indicated for the treatment of

by way of continuous gentle force.

tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth

The ClearCorrect retainers are produced from single-layer rigid polyurethane film.

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The ClearCorrect engager templates are produced from single-layer rigid PETG film.

TechnologicalCharacteristics:	A comparison of the relevant technological characteristicsbetween the subject and primary predicate devices is providedin the table that follows.
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Performance Data: Assessment of the risks associated with the subject device presented in this submission indicate that the following studies establish the substantial equivalence of the subject device to the identified predicate and reference devices:

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: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.

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Feature	Subject DeviceClearCorrect System	Primary Predicate DeviceClearCorrect System(K113618)	Reference DeviceOrmco™ SparkTM AlignerSystem(K182826)	Equivalence Discussion
Indicationsfor Use	The ClearCorrect System isindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e. allsecond molars). TheClearCorrect System positionsteeth by way of continuousgentle force.	The ClearCorrect System isindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e. allsecond molars). TheClearCorrect System positionsteeth by way of continuousgentle force.	The Ormco™ SparkTM AlignerSystem is indicated for thealignment of teeth duringorthodontic treatment ofmalocclusion in patients withpermanent dentition (i.e. allsecond molars). The Ormco™SparkTM Aligner Systempositions teeth by way ofcontinuous gentle force.	IdenticalThe indication for the Subjectdevice is the same as for thePrimary Predicate device.
TargetPatientPopulation	Adults (> 21 y.o.)Adolescents (12 – 21 y.o. havingpermanent second molars)	Adults (> 21 y.o.)Adolescents (12 – 21 y.o. havingpermanent second molars)	Adults (> 21 y.o.)Adolescents (12 – 21 y.o. havingpermanent second molars)	Identical
Mode ofAction /OperatingPrinciple	The aligner is an orthodonticappliance intended for intra-oraluse. Individual devices will beused between 20 – 22 hours perday for a period ranging fromone to three weeksThe corrective forces to alignteeth are primarily generated bythe difference between thestarting tooth position and theplanned tooth position definedby the tray. Features can beadded to the aligner that engagewith composite resin toothattachments to improve alignerretention and/or to apply force indirections that cannot beachieved by engaging with toothsurfaces alone.	The aligner is an orthodonticappliance intended for intra-oraluse. Individual devices will beused between 20 – 22 hours perday for a period ranging fromone to three weeksThe corrective forces to alignteeth are primarily generated bythe difference between thestarting tooth position and theplanned tooth position definedby the tray. Features can beadded to the aligner that engagewith composite resin toothattachments to improve alignerretention and/or to apply force indirections that cannot beachieved by engaging with toothsurfaces alone.	The corrective forces to alignteeth are primarily generated bythe difference between thestarting tooth position and theplanned tooth position definedby the tray. Features can beadded to the aligner that engagewith composite resin toothattachments to improve alignerretention and/or to apply force indirections that cannot beachieved by engaging with toothsurfaces alone.	Identical
Feature	Subject DeviceClearCorrect System	Primary Predicate DeviceClearCorrect System(K113618)	Reference DeviceOrmco™ SparkTM AlignerSystem(K182826)	Equivalence Discussion
AlignerMaterial	Thermoplastic polyurethane-polyester composite resin,tradename ClearQuartz	Thermoplastic polyurethane film	Thermoplastic polyurethane-polyester composite resin.	EquivalentThe Subject device has amultilayer construction ofpolyurethane and co-polyesterresins. The Reference Devicealso has a multilayerconstruction of polyurethane andco-polyester resins.
RetainerMaterial	0.030" rigid polyurethane film	0.030" rigid polyurethane film	Not relevant	IdenticalThe Retainer of the ClearCorrectSystem is unchanged from thepreviously cleared device.
EngagerTemplateMaterial	0.5 mm (0.02") rigid PETG film	0.5 mm (0.02") rigid PETG film	Not relevant	IdenticalThe Engager Template of theClearCorrect System isunchanged from the previouslycleared device.
Sterilization	Provided in non-sterilecondition. Not intended to besterilized before use.	Provided in non-sterilecondition. Not intended to besterilized before use.	Not relevant	IdenticalThe status of the Subject devicesis identical to that of the PrimaryPredicate devices.
Singe Use/Reuse	Repeated use by a single patient	Repeated use by a single patient	Repeated use by a single patient	IdenticalThe use profile of the Subjectdevices is identical to that of thePrimary Predicate devices.
Packaging	Primary: LDPE bag containingone or two appliances as definedby the prescribed treatment plan.Secondary: 20 pt C1S SBSpaperboard box	Primary: LDPE bag containingone or two appliances as definedby the prescribed treatment plan.Secondary: 20 pt C1S SBSpaperboard box	Not relevant	IdenticalThe packaging for the Subjectdevices is identical to that of thePrimary Predicate devices.

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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.