The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical malocclusions and Class I cases with mesially positioned maxillary molars.

Device Description

The Carriere Motion Clear Class II is a direct bond, esthetic, orthodontic appliance that attaches the maxillary canine or premolar to molar to provide a treatment solution for patients with malocclusions of primary, permanent or mixed dentition. The orthodontic appliance is a two-piece design comprised of an integrated polyethersulfone, a clear thermoplastic, anterior pad and rigid arm that connects to a 17-4 stainless steel posterior pad in a "ball and socket" relationship. The orthodontic appliance is intended to be used at the beginning of orthodontic treatment when there are no competing forces in the mouth. The device allows the distalization of the posterior segments.

The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping.

The Carriere Motion Clear Class II's application and removal is similar to that of a plastic orthodontic bracket. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for debonding.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically an orthodontic appliance. It primarily focuses on demonstrating substantial equivalence to existing devices rather than detailing a study proving the device meets specific acceptance criteria through performance.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of an AI/human-in-the-loop diagnostic device, cannot be fully extracted from this document. This document describes a physical orthodontic appliance, not a diagnostic algorithm.

However, I can extract information related to performance testing that was conducted:

Here's an attempt to answer your questions based only on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of the document.

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

Acceptance Criteria	Reported Device Performance
Biocompatibility:
Cytotoxicity	Passed
Sensitization	Passed
Irritation	Passed
Chemical Characterization (Toxicological Risk Assessment)	Passed
Bond Strength:
Substantially equivalent to predicate and reference devices. Below 8.2 MPa (literature value for no enamel damage).	Carriere Motion Clear Class II: 22.05 lbf/5.28 MPa
	Predicate Device (Carriere Motion Class II): 16.52 lbf/4.04 MPa
	Reference Device (Composite Brackets): 10.72 lbf/3.87 MPa

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

Sample Size for Test Set: Not explicitly provided for biocompatibility or bond strength testing.
Data Provenance: Not provided. The tests are described as conducted in accordance with FDA and ISO standards, but the location or whether the data was retrospective/prospective is not mentioned.

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 Applicable. This document does not describe a study involving expert assessment or ground truth establishment for a diagnostic algorithm. The "ground truth" for the bond strength appears to be the measured force required for bonding/debonding, and for biocompatibility, it's compliance with standard biological evaluation tests.

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

Not Applicable. No adjudication method is mentioned as this is not a diagnostic study requiring human expert review for establishing ground truth.

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

No. A MRMC comparative effectiveness study was not done. This document is for a physical orthodontic appliance, not an AI-assisted diagnostic device.

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

No. A standalone performance study of an algorithm was not done. This document is for a physical orthodontic appliance.

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

For Biocompatibility: Compliance with established biological evaluation standards (ISO 10993). The "ground truth" is that the material does not elicit adverse biological responses.
For Bond Strength: Measured force in lbf/MPa. The "ground truth" refers to the quantified mechanical adhesion strength.

8. The sample size for the training set

Not Applicable. This document describes a physical medical device, not an AI algorithm requiring a training set.

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

Not Applicable. No training set or associated ground truth establishment is relevant to this device submission.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized and appear to be connected.

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

November 28, 2016

Ortho Organizers, Inc. Colleen Boswell Director, RA/OA 1822 Aston Avenue Carlsbad, California 92008

Re: K160720

Trade/Device Name: Carriere Motion Clear Class II Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: DYW, EJF Dated: October 26, 2016 Received: October 27, 2016

Dear Colleen Boswell:

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 devicerelated 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.

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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" (21 CFR 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 yours,

Susan Runna DDS, MA

Tina Kiang Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation 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: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K160720

Device Name Carriere Motion Clear Class II

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."

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Image /page/3/Picture/1 description: The image contains the logo for Ortho Organizers, a Henry Schein company. The logo features a blue circle with the text "O2" inside, followed by the word "ORTHO" in gold lettering. Below "ORTHO" is the word "Organizers" in a smaller font, and below that is the text "A HENRY SCHEIN COMPANY" with a small logo to the left.

510(k) Summary

1. Submitter:
  Ortho Organizers, Inc. 1822 Aston Avenue Carlsbad, California 92008

Contact Person:	Colleen Boswell
Telephone Number:	(760) 448-8730
Fax Number:	(760) 448-8616

Date Prepared: November 17, 2016

1. Device:

Name of Device:	Carriere Motion Clear Class II
Common Name:	Orthodontic Appliance
Classification Name:	Orthodontic Plastic Bracket, per 21 CFR § 872.5470
Device Class:	II
Product Code:	DYW

1. Predicate Device:
  Primary Predicate: Carriere Motion Class II, Ortho Organizers, Inc., Class I 510(k) Exempt, Product Code EJF

Reference Device: Composite Brackets, Ortho Specialties, Inc., K140807

4. Device Description

The Carriere Motion Clear Class II corrects the posterior occlusion to a Class I platform first by rotating and uprighting the maxillary molars while distalizing the posterior segment, from canine or

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premolar to molars. The orthodontic appliance independently moves each posterior segment, from canine or premolar to molar, as a unit. The anterior pad includes an integrated hook which allows for the attachment of elastics to the lower molars. The posterior pad bonds to the facial surface of the teeth and is made of 17-4 stainless steel. The pad serves as the socket in the ball and socket relationship with the plastic arm. The ball and socket has built-in stops that allow the molars to move directly to their desired position and are intended to prevent any unwanted over rotation or tipping.

1. Statement of Intended Use:
  The Carriere Motion Clear Class II orthodontic appliance is intended to provide orthodontic movement and alignment of teeth during orthodontic treatment for Class II cases with symmetrical and asymmetrical malocclusions and Class I cases with mesially positioned maxillary molars.
1. Summary of Technological Characteristics with the Predicate Devices
  The technological characteristics of the proposed Carriere Motion Clear Class II are very similar to the predicate device, Carriere Motion Class II (Class I, 510(k) Exempt) and the reference device, Composite Brackets (K140807). There are no substantial or functional differences between the Carriere Motion Clear Class II appliance and the predicate and reference devices in terms of design, function, biocompatibility and intended use. See Table 1 below for technological characteristics and comparisons of the orthodontic appliances.

Element	Carriere Motion ClearClass II	Predicate DeviceCarriere Motion Class II(Class I, 510(k) Exempt)	Reference DeviceComposite Brackets(K140807)	Comparison
Company	Ortho Organizers, Inc. (02)	Ortho Organizers, Inc. (02)	Ortho Specialties, Inc.	N/A
Indications forUse	The Carriere Motion ClearClass II orthodonticappliance is intended toprovide orthodonticmovement and alignmentof teeth duringorthodontic treatment forClass II cases withsymmetrical andasymmetricalmalocclusions and Class Icases with mesiallypositioned maxillarymolars.	The Carriere Motion Class IIorthodontic appliance isintended to provideorthodontic movement andalignment of teeth duringorthodontic treatment forClass II cases withsymmetrical andasymmetrical malocclusionsand Class I cases withmesially positionedmaxillary molars.	The CompositeBrackets are intendedfor use as a clear,plastic bracket systemto provide orthodonticmovement of naturalteeth.	Indicated for samepurpose - movement ofteeth.
Target Users	Dental Professionals	Dental Professionals trained	Dental Professionals	Same
Element	Carriere Motion ClearClass II	Predicate DeviceCarriere Motion Class II(Class I, 510(k) Exempt)	Reference DeviceComposite Brackets(K140807)	Comparison
	trained in orthodontics	in orthodontics	trained in orthodontics
ApplianceMaterial	Polyethersulfone/17-4 Stainless Steel	17-4 Stainless Steel	Polycarbonate	Both thermoplasticmaterials (same asreference) with 17-4stainless steel identicalto predicate
Features	Two-piece designcomprised of anintegrated plastic anteriorpad and rigid arm thatconnects to a 17-4stainless steel posteriorpad in a "ball and socket"relationship.	Two-piece designcomprised of an integrated17-4 stainless steel anteriorpad and rigid arm thatconnects to a 17-4 stainlesssteel posterior pad in a "balland socket" relationship.	One-piece design thatconnects to otherbrackets via archwiresand/or elastics.	2-piece design identicalto predicate vs. 1-piecebracket design ofreference. The rigidarm across a posteriorsegment of 3-4 teethallows teeth to bepositioned into a ClassII relationship withmore predictability anduniformity as opposedto the referencedevice's reliance onmultiple bracketsconnected via anarchwire
	Translucent plasticanterior pad that bonds tothe facial surface of teeth.	17-4 stainless steel anteriorpad that bonds to the facialsurface of teeth.	Translucent bracketpad that bonds to thefacial surface of teeth.	Both thermoplasticpads (same asreference) and 17-4stainless steel pad ofpredicate bonds toteeth with differentretention geometries ofthe pad. However, thepad's use as anchorageto the tooth serves thesame purpose.
	The anterior pad includesan integrated clear plastichook for elastic activation.	The anterior pad includesan integrated 17-4 stainlesssteel hook for elasticactivation.	The brackets areavailable withintegrated hooks forelastic activation.	Same. All haveintegrated hooks forelastic activation.
	The posterior pad bondsto the facial surface ofteeth and is made of 17-4stainless steel. The padserves as the socket in the"ball and socket"relationship with thepolyethersulfone arm.Color coded for applianceidentification	The posterior pad bonds tothe facial surface of teethand is made of 17-4stainless steel. The padserves as the socket in the"ball and socket"relationship with the 17-4stainless steel arm.Color coded for applianceidentification	The base bonds to thefacial surface of teeth.Mechanical Retentioneliminates the need forplastic condition pre-treatment.	Posterior pad identicalwith predicate andbonds to facial surfaceof teeth.
	Color coded for applianceidentification	Color coded for applianceidentification	Color coded for bracketidentification	Same
Element	Carriere Motion ClearClass II	Predicate DeviceCarriere Motion Class II(Class I, 510(k) Exempt)	Reference DeviceComposite Brackets(K140807)	Comparison

Mode of Use	Removable elastics(provided by clinician andworn by patient) areattached to the device andanchored to the opposingdental arch to providevector forces required tomove teeth per dentalprofessional's techniqueand treatment goals.	Removable elastics(provided by clinician andworn by patient) areattached to the device andanchored to the opposingdental arch to providevector forces required tomove teeth per dentalprofessional's techniqueand treatment goals.	Archwireimplementation bydental professional'stechnique.	Use of elastics to applythe proper amount offorce to move teeth isidentical withpredicate. Archwireused to apply the forceto move teeth with thereference device. Thisis not a significantdifference as the forcesused in both scenariosare equivalent asprescribed by theclinician.
Application	Bonded with OrthodonticAdhesive	Bonded with OrthodonticAdhesive	Bonded withOrthodontic Adhesive	Same
Bond Strength(lbf/MPa)	22.05/5.28	16.52/4.04	10.72/3.87	Higher bond strengththan predicate andreference devices. Allbelow 8.2 MPa, a valuein literature that showsno risk of enameldamage.
ManufacturingMethod	Molded	Molded	Molded,thermoformed.	Same

Table 1: Comparison of Proposed and Predicate/Reference Devices

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7. Performance Data

Biocompatibility Testing

The biocompatibility evaluation for the Carriere Motion Clear Class II orthodontic appliance was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995 and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included the following tests:

1. Cytotoxicity
1. Sensitization
1. Irritation
1. Chemical Characterization Study (Toxicological Risk Assessment)

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Bond Strength Testing

Bond strength testing was performed on the Carriere Motion Clear Class II orthodontic appliance and compared to the primary predicate and reference devices and was substantially equivalent to these devices.

Clinical Studies

No human clinical testing was conducted to support substantial equivalence.

8. Conclusion as to Substantial Equivalence

The similarities in design, function, safety and intended use of the Carriere Motion Clear Class II orthodontic appliance with the legally marketed predicate device, Carriere Motion Class II (Class I, 510(k) Exempt) and reference device, Composite Brackets (K140807), support substantial equivalence.

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.