The Clear Image Aligners are a sequential set of removable aligners prescribed by an orthodontist or dentist, used to gradually move a patient's teeth in order to treat misalignment and malocclusion. Each aligner in the sequential set is created by a trained technician utilizing 3Shape orthodontic software (K171634/K152086) and tooth movement recommendations from the prescribing orthodontist/dentist. Aligners are then fabricated from plastic. Corrective force to progressively reposition the teeth is delivered via minor changes from one aligner to the next within the series.

Each aligner set is patient specific and can only be used for an individual patient for whom it is prescribed. Clear Image Aligners are provided non-sterile and are completely removable by the patient and treatment/use may be discontinued at any time.

AI/ML Overview

The provided text describes a 510(k) premarket notification for "Clear Image Aligners" by Specialty Appliance Works, Inc. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove the device meets specific acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested details about acceptance criteria and study design are not applicable or not provided in this regulatory submission.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable. This submission does not define specific acceptance criteria (e.g., accuracy, sensitivity, specificity) for device performance. Instead, it aims to demonstrate substantial equivalence to a legally marketed predicate device.

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

Not applicable. No "test set" in the context of performance evaluation (e.g., for AI algorithm metrics) is described. The submission states that clinical testing was not necessary due to the established performance of sequential aligners.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not applicable. No ground truth establishment by experts for a performance study is described.

4. Adjudication Method

Not applicable. No adjudication method for a test set is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study is mentioned. This device is an aligner, not an AI or imaging diagnostic tool that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical orthodontic aligner, not an algorithm. The manufacturing process uses 3Shape orthodontic software, but the submission doesn't describe a standalone performance study of this software or the aligner.

7. Type of Ground Truth Used

Not applicable. No performance study with ground truth is described.

8. Sample Size for the Training Set

Not applicable. No training set for an AI algorithm is described.

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

Not applicable. No training set or ground truth establishment process is described.

Summary of the Study and Substantial Equivalence Claim:

The submission asserts that clinical testing was not necessary because:

Established Performance: "The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998."
Substantial Equivalence: The Clear Image Aligners are deemed substantially equivalent to the predicate device (Derby Dental Laboratory Custom Clear Aligner System, K173785) in terms of:
- Indications for Use
- Design and Technology
- Device Classification Name (Orthodontic Plastic Bracket)
- Product Code (NXC)
- Classification (Class II)
- Mode of Action (alignment of teeth by application of continuous gentle force, by sequential use of preformed plastic trays)
- Method of Use
- Prescription Status (Prescription)
- Software Used during manufacturing (3Shape Ortho System)
- Sterility (Provided Non-Sterile)
- Material (Essix Ace plastic - K062828, described as a thin thermoformed polyurethane). The mechanical properties of this plastic were previously demonstrated by the manufacturer.

In essence, the "study" demonstrating the device meets the acceptance criteria (of being safe and effective) is the history of successful use of similar predicate devices and the demonstration that the proposed device shares the same fundamental technological characteristics and intended use as the predicate. This is a common approach for 510(k) clearances when a novel technology is not being introduced.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Specialty Appliance Works, Inc. % Mark Job Official Correspondent Regulatory Technology Services, LLC 1394 25th Street, Nw Buffalo, Minnesota 55313

Re: K183643

Trade/Device Name: Clear Image Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: December 21, 2018 Received: December 26, 2018

Dear Mark Job:

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

January 3, 2019

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Digitally signed by Mary Mary S. = S. Runner -S3 19.01.03 - 5.3 - Date: 2019.01.03
Runner - 5.3 - Date: 2019.01.03
Runner - 5.3 - 09:06:24 -05'00' For Tina Kiang, Ph.D. 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 Form Approved: OMB No. 0910-0120 Food and Drug Administration Expiration Date: 06/30/2020 Indications for Use See PRA Statement below. 510(k) Number (if known)

Device Name Clear Image Aligners

Indications for Use (Describe)

The Clear Image Aligners are indicated for use in the alignment teeth through orthodontic treatment of misalignment and 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.

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"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

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FORM FDA 3881 (7/17)

FSC Publiching Seessour (306) 443-678)

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Image /page/3/Picture/0 description: The image shows the logo for Specialty Appliances. The logo consists of a cluster of gray circles on the left, arranged in a circular pattern. To the right of the circles, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller font size.

510(k) Summary

Date Prepared:	November 16, 2018
Submitter:	Specialty Appliance Works, Inc.4905 Hammond Industrial DriveCumming, GA 30041
Contact:	Carolyn ThomasQuality ManagerSpecialty Appliance Works, Inc.(678) 513-4408Carolyn.Thomas@specialtyappliances.com
Proprietary Name:	Clear Image Aligners
Common Name:	Sequential Aligners
Classification:	21 CFR 872.5470: Orthodontic plastic bracket; Class II
Product Code:	NXC
Predicate Device:	K173785, Derby Dental Laboratory Custom Clear AlignerSystem

Intended Use / Indications:

The Clear Image Aligners are indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.

Device Description:

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Image /page/4/Picture/0 description: The image contains a logo for "Specialty Appliances". The logo features a circular design on the left, composed of multiple smaller circles arranged in a pattern. To the right of the circular design, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller font size.

Non-Clinical Testing:

Specialty Appliance Works, Inc. has completed biocompatibility testing per ISO 10993-1 and its applicable parts, as appropriate for the aligner contact and duration. The mechanical properties of the Essix Ace plastic (K062828) has been previously demonstrated by the manufacturer as appropriate for use with aligners, therefore no additional testing was required.

Clinical Testing:

The performance of sequential aligners in the clinical environment has been well established since the first aligners were cleared by the FDA under product code NXC in 1998. Therefore, clinical testing was not necessary to demonstrate substantial equivalence of the Clear Image Aligners to the predicate device.

Property orCharacteristic	Proposed DeviceSpecialty Appliance Works,Inc.Clear Image Aligners	Predicate DeviceDerby Dental LaboratoryCustom Clear AlignerSystem (K173785)	Comments
Device ClassificationName	Orthodontic Plastic Bracket	Orthodontic Plastic Bracket	Same as K173785
Product Code	NXC	NXC	Same as K173785
Classification	II	II	Same as K173785
Indications for Use	The Clear Image Alignersare indicated for use in thealignment of permanentteeth through orthodontictreatment of misalignmentand malocclusion.	The Custom Clear AlignerSystem is indicated for usein the alignment ofpermanent teeth throughorthodontic treatment ofmisalignment andmalocclusion.	Same as K173785
Mode of Action	Alignment of teeth byapplication of continuous	Alignment of teeth byapplication of continuous	Same as K173785

Predicate Device Comparison:

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Image /page/5/Picture/0 description: The image contains the logo for Specialty Appliances. The logo features a circular design composed of several smaller circles on the left side. To the right of the circular design, the word "Specialty" is written in a bold, sans-serif font. Below "Specialty", the word "Appliances" is written in a smaller, sans-serif font.

Property orCharacteristic	Proposed DeviceSpecialty Appliance Works, Inc.Clear Image Aligners	Predicate DeviceDerby Dental LaboratoryCustom Clear Aligner System (K173785)	Comments
Method of Use	gentle force, by sequentialuse of preformed plastictrays.Each preformed plastic trayis worn by the patient asprescribed by theorthodontist/dentist prior tousing the next sequentialaligner tray.	gentle force, by sequentialuse of preformed plastictrays.Each preformed plastic trayis worn by the patient asprescribed by the dentalpractitioner, usually a fewweeks prior to using thenext sequential aligner tray.	Same as K173785
	Material	Essix Ace plastic(K062828)	Thin thermoformedpolyurethane
Prescription or OTC	Prescription	Prescription	Same as K173785
Software Used duringmanufacturing	Use of 3Shape OrthoSystem(K171634/K152086)	Use of 3Shape OrthoSystem (K152086)	Same as K173785
Provided Non-Sterile	Yes	Yes	Same as K173785

Summary of Substantial Equivalence:

Based on the information presented in this submission, Specialty Appliance Works, Inc. concludes that the Clear Image Aligners are substantially equivalent to the predicate device in regard to indications for use, design and technology.

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.