The Clear21™ orthodontic ceramic bracket system from World Class Technology Corporation is a system of aesthetic passive self-ligating brackets for fixed appliance orthodontic treatment. The brackets are bonded directly to patient's teeth of the maxillary arch. The self-ligating mechanism (i.e. the door) eliminates the need for elastomeric and steel ligatures. The system is intended for use with clinician chosen orthodontic auxiliary devices.

AI/ML Overview

The requested information is not available in the provided document. The document describes a 510(k) premarket notification for an orthodontic ceramic bracket system (Clear21) and primarily focuses on proving its substantial equivalence to a legally marketed predicate device (Damon Clear/Clear2) through non-clinical testing.

Here's a breakdown of why the requested information about AI acceptance criteria and study proving device performance against those criteria cannot be extracted from this document:

Device Type: The Clear21 is an orthodontic ceramic bracket system, which is a physical medical device used for moving teeth. It is not an AI-powered device or software.
Study Focus: The "Performance Data" section (page 6) explicitly states "Non-Clinical Testing" and "Functional testing was done to compare the Clear21 bracket's performance to that of its predicate and reference devices." It further clarifies, "Clinical Testing - Clinical testing is not included in this submission."
Lack of AI-related metrics: The performance criteria discussed relate to mechanical properties of the bracket (ligation mechanism, structural integrity, bond strength, door open/close force, door pull-out, rotational strength, hook strength). There are no metrics related to AI performance such as sensitivity, specificity, AUC, or reader performance with or without AI assistance.
Ground Truth: The ground truth for this device would be its physical properties and mechanical performance, not expert consensus on image interpretation or pathology.
No mention of experts or adjudication: Since it's a physical device and not an AI-assisted diagnostic tool, there's no mention of experts establishing ground truth for a test set or any adjudication methods.
No training set or MRMC study: As there is no AI component, there are no training sets or MRMC studies to evaluate human reader improvement with AI.

Therefore, the document does not contain the information required to answer the prompt regarding AI acceptance criteria and the study proving a device meets those criteria.

Summary

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November 12, 2019

World Class Technology Corporation % Alyssa Thomas Principal Consultant Allegiance Regulatory Consulting LLC 16642 SW Lansford Ct. Beaverton, Oregon 97007

Re: K192202

Trade/Device Name: Clear21 Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NJM Dated: August 9, 2019 Received: August 14, 2019

Dear Alyssa Thomas:

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.

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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 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 (QS) 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 medical devices and radiation-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,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental 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) K192202

Device Name

Clear21TM

Indications for Use (Describe)

The Clear21™ orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.

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)

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This summary of 510(k) information is being submitted in accordance with the requirements of SMDA (Safe Medical Devices Act) 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K192202

5.1. Submitter Contact Information

Name:	World Class Technology Corporation
Address:	1300 NE Alpha DriveMcMinnville, OR 97128, USA
Phone:	503-472-8320
Fax:	503-435-2432
Contact:	Alan Kozlowski
Date Prepared:	November 11, 2019

5.2. Device Identification

Trade Name:	Clear21™
Common Name:	Orthodontic Ceramic Bracket
Classification Name:	Orthodontic Plastic Bracket
Regulatory Class:	872.5470
Product Code:	NJM

5.3. Legally Marketed Predicate Device(s)

Predicate Device: K081415 Ormco Corporation's Damon 4Clear (currently marketed as "Damon Clear" and "Damon Clear2")

Reference Device: K173440 Ortho Organizers, Incorporated/Henry Schein Orthodontics' Carriere SLX 3D Clear

5.4. Device Description

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maxillary arch. The self-ligating mechanism (i.e. the door) eliminates the need for elastomeric and steel ligatures. The system is intended for use with clinician chosen orthodontic auxiliary devices.

5.5. Intended Use/Indications for Use

The Clear21™ orthodontic ceramic bracket system is intended to aid in the movement of teeth during orthodontic treatment.

5.6. Summary of Technological Characteristics

The Clear21 bracket system includes brackets designed to provide the aesthetic benefit of clear ceramic materials with the function of traditional metal brackets. The brackets are available for the upper maxillary teeth from the second bicuspid to the second bicuspid, i.e. 5 to 5. The bracket body and door are ceramic injection molded. The threecomponent bracket assembly includes the bracket body, door and a spring. The Clear21 bracket is similar in materials, design, manufacturing processes and principles of operation as the predicate device (Damon Clear2). There are no significant differences between the Clear21 device and the predicate. A table comparing the key features of the subject device and the predicate device is provided below (Table 5-1Table 5-1).

	Clear21(Subject Device)	Damon Clear / DamonClear2(K081415)
Manufacturer /Marketing Company	World Class TechnologyCorporation	Ormco Corporation
Intended Use /Indication for Use	The Clear21™ orthodonticceramic bracket system isintended to aid in themovement of teeth duringorthodontic treatment.	The Damon 4Clear* is aceramic bracket systemintended to aid in themovement of patient teethduring orthodontictreatment.* Name at the time of submission
Clinical Application	Orthodontic Treatment	Orthodontic Treatment
Clinical Setting / Siteof Use	Prescription Device forOrthodontic Clinic Use	Prescription Device forOrthodontic Clinic Use
	Clear21	Damon Clear / DamonClear2(K081415)
	(Subject Device)
Target User	Dental professionals trainedin orthodontic treatment	Dental professionals trainedin orthodontic treatment
	Technology Characteristics
Device Materials	Polycrystalline Alumina &Nitinol	Polycrystalline Alumina &Nitinol
Device Design	Three-componentconstruction comprised of aceramic door & body with anitinol spring element. Thespring provides force for theligating mechanism	Three-componentconstruction comprised of aceramic door & body with anitinol spring element. Thespring provides force for theligating mechanism
Bracket Base Design	Base designed for directbonding to the facial surfaceof the teeth. The bracketbonding pad/base includesmechanical retentionfeatures that are formed inthe ceramic material	Base designed for directbonding to the facial surfaceof the teeth. The bracketbonding pad/base utilizesmechanical retentionfeatures that are laser cutinto the ceramic material
Bracket Hook Feature	Select brackets include anintegrated hook foraccessory attachment	Select brackets include anintegrated hook foraccessory attachment
Ligation Method	Self-Ligating	Self-Ligating
Bracket Identification	Color-coded Dots	Color-coded Dots
Manufacturing Method	- Ceramic Injection Molded- Processed Pad/Base- Spring Cut from FlatStock- Component Assembly	- Ceramic Injection Molded- Laser-Etch Pad/Base- Spring Formed into aTubular Split Pin- Component Assembly
Functional Dimension (Prescription)
In-Out	0.0265" - 0.0385"	0.03" - 0.040"
Torque	-11 deg. through +12 deg.	-11 deg. through +22 deg.
Angulation	2 to 9 deg.	2 to 9 deg.
Rotation	None of the brackets in thesystem incorporate rotation	None of the brackets in thesystem incorporate rotation
	Clear21	Damon Clear / DamonClear2
	(Subject Device)	(K081415)
Principles of Operation
Mode of Use	An archwire, selected by theclinician, is inserted into thearchwire slots in thebrackets and the ligatingdoor is closed, securing thearchwire in the slot. Thearchwires provide the forcesneeded to move the teeth inaccordance with the dentalprofessional's goals andtechnique.	An archwire, selected by theclinician, is inserted into thearchwire slots in thebrackets and the ligatingdoor is closed, securing thearchwire in the slot. Thearchwires provide the forcesneeded to move the teeth inaccordance with the dentalprofessional's goals andtechnique.
Application	Bracket pad/base is directlybonded to the facial surfaceof the tooth using typicalorthodontic adhesives andbonding techniques	Bracket pad/base is directlybonded to the facial surfaceof the tooth using typicalorthodontic adhesives andbonding techniques

Table 5-1 Subject & Predicate Device Comparison

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5.7. Performance Data

Non-Clinical Testing - The application includes detailed discussions of nonclinical testing. In all instances, the Clear21 bracket device preformed as intended. Biocompatibility testing was also performed, demonstrating that the bracket materials and processing are acceptable based on the contact category for the Clear21 brackets. Functional testing was done to compare the Clear21 bracket's performance to that of its predicate and reference devices. A reference device, the Carriere SLX bracket, was used to compare the bond strength performance of the Clear21 bracket. The predicate device incorporates a unique proprietary bond base and the reference device uses a bond base design similar to the Clear21 and is more consistent with typical bond base designs. The ligation mechanism, structural integrity and bond strength of the Clear21 bracket are similar to the predicate and reference devices, as demonstrated through the results of functional testing. The Clear21 bracket produces similar results for ligating door open/close force range values, door pull-out, rotational strength, hook strength and bond strength. The nonclinical evaluations provide evidence of the Clear21 bracket's safety and effectiveness when used as intended.

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Clinical Testing - Clinical testing is not included in this submission

5.8. Substantial Equivalence

The Clear21 brackets are as safe and effective as the predicate, the Damon Clear2. The Clear21 bracket system has the same indications for use as the predicate device. Clear21 has similar technological characteristics and principles of operation as its predicate device. The minor technological differences between the Clear21 brackets and its predicate device raise no new or different issues of safety or effectiveness, as evident by the comparison testing. The performance data demonstrates that the Clear21 brackets are as safe and effective as the Damon Clear/Clear2 brackets. Thus, the Clear21 is substantially equivalent.

5.9. Conclusions

Conclusions drawn from the comparison to the predicate device and the nonclinical testing demonstrate that the Clear21 ceramic bracket system is as safe, as effective, and performs as well as the predicate device.

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.