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 ClearCorrect device is fabricated of clear thin thermoformed polyeurathane plastic in a sequential series to progressively reposition the teeth. Corrective force to straighten the teeth is delivered via minor changes into a position in each subsequent aligner.

AI/ML Overview

The provided text describes the ClearCorrect System, an invisible braces system, and its substantial equivalence to predicate devices, rather than presenting a study with detailed acceptance criteria and performance data for a new device. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and statistical outcomes is not explicitly available in the provided text.

However, based on the information provided, here's a structured response addressing the requested points to the best of my ability, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of acceptance criteria with specific quantitative targets and corresponding device performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of intended use, technological characteristics, and principles of operation, along with general non-clinical testing.

Acceptance Criteria Category	Specific Criteria (Implicit or Explicit from Text)	Reported Device Performance (Summary from Text)
Intended Use	Treatment of tooth malocclusion in patients with permanent dentition.	"Comparable in the FS Aligner and the same in the unmodified ClearCorrect System."
Mode of Action	Alignment of teeth by sequential use of preformed plastic trays.	"Comparable in the FS Aligner System and the same in the unmodified ClearCorrect System."
Material	Thin thermoformed plastic material.	"Comparable over all three systems" (Predicate materials: Thermoformed polycarbonate, ClearCorrect Modified: Thermoformed polyeurathane).
OTC or Rx	Prescription Use.	"Same" (Rx for all).
Biocompatibility	USP Class VI, ISO 10993-5 Cytotoxicity, ISO 10993-10 Intracutaneous Intradermal reactivity, Oral Mucosa Irritation test, Maximum test for Delayed Type Hypersensitivity.	"Found to be acceptable and supports the claims of substantial equivalence."
Visual Performance	(Not specified with criteria)	Non-clinical testing performed. Results found acceptable.
Mechanical Performance	(Not specified with criteria)	Non-clinical testing performed. Results found acceptable.
Device Processing Performance	(Not specified with criteria)	Non-clinical testing performed. Results found acceptable.

2. Sample Size Used for the Test Set and Data Provenance

The text does not specify a sample size for a test set as it relies on non-clinical testing and substantial equivalence to predicate devices, rather than a de novo clinical or performance study with a dedicated test set. The data provenance is not mentioned, as detailed data from a specific study is not presented.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable or available in the provided text. The submission focuses on demonstrating equivalence to existing devices and non-clinical testing, not on a study requiring expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable or available as there is no specific test set or clinical study described requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission explicitly states, "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."

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

The ClearCorrect System is a physical device (invisible braces) and not an algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context.

7. The Type of Ground Truth Used

Given that no clinical study with explicit ground truth determination is described, this information is not applicable or available. The submission's "ground" for approval is substantial equivalence to predicate devices, supported by non-clinical performance and biocompatibility testing.

8. The Sample Size for the Training Set

This information is not applicable or available. The ClearCorrect System is a physical medical device, not a machine learning algorithm that requires a "training set" in the conventional sense.

9. How the Ground Truth for the Training Set was Established

This information is not applicable or available for the same reason as point 8.

Summary

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K1136/8

Section 5 - 510(k) Summary for ClearCorrect System

1. Submission Sponsor

ClearCorrect LLC 15151 Sommermeyer St. Houston, Texas 77041 United States Phone: (713) 850-1036 x 11 e-mail: pgarcia@clearcorrect.com Contact: Pedro Garcia, VP of QA/RA ClearCorrect LLC

2. Submission Correspondent

Emergo Group 611 West 5th Street, Third Floor Austin, TX 78701 Cell Phone: Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Cheryl Fisher, Sr. QA/RA Consultant Email: project.management@emergogroup.com

1. Date Prepared
  10/31/2011

4. Device Name

Trade/Proprietary Name: ClearCorrect System Common/Usual Name: Invisible braces Classification Name: Sequential Aligner Classification Regulation: 872.5470 Classification Panel: 872 Dental Product Code: NXC Device Class:2

FDA Establishment Registration #: 3007130440-

Predicate Devices 5.

ClearCorrect System, ClearCorrect LLC K082556 FS Aligner System, Sybron Dental Specialties K093821

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ClearCorrectLLC Traditional 510(k) Premarket Submission ClearCorrect System

6. Device Description

7. Intended Use

8. Summary of Usage

A dental health care professional (e.g. orthodontists or dentists), prescribes the ClearCorrect 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. The molds and prescription are sent to ClearCorrect. Utilizing standard dental software used for tooth alignment, ClearCorrect designs a series of plastic trays intended to gradually realign the patient's teat briefd.
the physicing's provincial and since and the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, ClearCorrect the model schefne
of cloar, thin thermator worked, ClearCorrect produces the trays, which are formed of clear, thin thermoformed polyeurathaneplastic. 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 of months, additional trays are provided sequentially to the patient by the dental health care professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when treatment is completed. The trays are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced below.

9. Technological Characteristics and Substantial Equivalence

The following table compares the ClearCorrect Systemsto the predicate devices, ClearCorrect System unmodified and the FS Aligner System with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

Feature	FS	ClearCorrect	ClearCorrectmodified	Comparison
510 (k)Number	K093821	K082556	Not yet assigned
Manufacturer	Sybron DentalSpecialties	ClearCorrect LLC	ClearCorrect LLC
Classification#	872-5470	872-5470	872-5470	Same
Product Code	NXC	NXC	NXC	Same
Intended Use	The FS Aligner System	The	The	Comparable in

Comparison Table

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ClearCorrectLLC

Traditional 510(k) Premarket Submission ClearCorrect System

is intended for minoranterior toothmovement in patientswithpermanent dentition(second molars). TheFS Aligner Systempositions teeth by wayofcontinuous gentleforce.	ClearCorrectSystemis indicated for thetreatment of toothmalocclusion inpatients withpermanentdentition (i.e. allsecond molars),The ClearCorrectSystem positionsteeth by way ofcontinuous gentleforce	ClearCorrectSystem isindicated for thetreatment of toothmalocclusion inpatients withpermanent dentition(i.e. all secondmolars), The.ClearCorrect Systempositions teeth byway of continuousgentle force	the FS Alignerand the samein theunmodifiedClearCorrectSystem
Mode ofAction	Each appliance isworn by patient asdetermined by dentalpractitioner. Generally2-4 weeks prior tousing the nextsequential aligner	Alignment of teethby sequential useof preformedplastic trays	Alignment of teeth bysequential use ofpreformed plastictrays	Comparable inthe FS AlignerSystem and thesame in theunmodifiedClearCorrectSystem
Material	Thin thermoformedplastic material	Thermoformedpolycarbonate	Thermoformedpolyeurathane	Comparableover all threesystems
OTC or Rx	Rx	Rx	Rx	Same

10. Non-Clinical Testing

1. Visual Performance
1. Mechanical Performance
1. Device Processing performance
1. Biocompatibility

Materials

. USP Class VI
Finished Product Biocompatibility
ISO 10993-5 Cytotoxicity .
. ISO 10993-10 Intracutaneus Intradermal reactivity, Oral Mucosa Irritation test, Maximum
test for Delayed Tuna H test for Delayed Type Hypersensitivity

11. Clinical Testing

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The substantial equivalence of the mulcations for use is

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non-clinical testing. The verification and validation testing of the device biocompatibility and performance testing was found to be acceptable and supports the claims of substantial equivalence.

12. Conclusion

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

lt has been shown in this 510(k) submission that the difference between the ClearCorrect System and the predicate devices do not raise any questions regarding its safety and effectiveness. The ClearCorrect System, as designed and manufactured, is determined to be substantially equivalent to the referencedpredicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with outstretched wings. The image is in black and white.

Public Health Service

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

ClearCorrect LLC C/O Ms. Cheryl Fisher Senior OA/RA Consultant Emergo Group 611 W. 5TH Street, Third Floor Austin, TX 78701

Re: K113618

Trade/Device Name: ClearCorrect System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: March 1, 2012 Received: March 2, 2012

Dear Ms. Fisher:

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.

MAR 1 9 2012

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Page 2 - Ms. Fisher

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K 11 3 618

Indications for Use Statement

510(k) Number (if known): Not Assigned K1136 | 8

Device Name: ClearCorrect System

Indications for Use:

Prescription Use X_ (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _____________________________________ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruaper

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number. K113618

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.