eCligner® is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). The eCligner® is intended for minor anterior tooth movement by way of continuous gentle force.

Device Description

eCligner® is a transparent and removable orthodontic appliance. eCligner® is a digitally- made Clear Aligner by the 3DCAD/CAM system. By printing the completed setup data into a series of plastic models, eCligne® is produced by a simple stamping procedure (Vacuum forming). eCligner® is designed for orthodontic tooth movement. Each step for using orthodontic appliance, eCligner® consists of 3 weeks (1 week for soft, 1 week for medium and 1 week for hard) and wearing the appliance 17 hours a day for each sequence is required. * More than 3 weeks of wearing may be required per step depending on the direction of orthodontic treatment and dentist's instruction. * eCligner® -H is used for 3 weeks during Final process. During one individual step of treatment, three aligners of different layer thickness are worn in weekly intervals. The applied layer thicknesses are 0.5 mm (medium) and 0.75 mm (hard). Each individual step is consisting of three different thickness appliances as follows: 1. eCligner® -S (Soft) 2. eCligner® -M (Medium) 3. eCligner® -H (Hard) *eCligner® -UH (Ultra Hard, 1.00mm) is used only for the patient with Bruxism (Teeth Grinding) since the aligner can be broken while the patient grinds their teeth unintentionally.

AI/ML Overview

This document (K143499) is a 510(k) premarket notification for the eCligner® orthodontic plastic bracket device. The document primarily focuses on establishing substantial equivalence to a predicate device (Invisalign® System, K081960). It does not contain information about acceptance criteria, detailed device performance, or a specific study proving the device meets acceptance criteria in the way typically expected for a medical device efficacy study.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance:

The document does not provide a table of acceptance criteria with corresponding device performance metrics (e.g., accuracy, sensitivity, specificity, or tooth movement outcomes). Instead, it focuses on demonstrating substantial equivalence based on similar design, materials, and mechanism of action to a legally marketed predicate device.

The "Performance Testing" section mentions:

Biocompatibility tests: These were performed in accordance with ISO 10993. The document states "Biocompatibility tests such as cytotoxicity, irritation, and sensitization were performed," but it does not report the acceptance criteria or the results of these tests.
Software validation test: This was performed for the CAD/CAM system used to fabricate the device, according to FDA guidance. The document states "A performance qualification of the available software utilized in the processing steps of the subject device has been included to support substantial equivalence," but it does not report specific acceptance criteria or results from this validation.

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

No information is provided regarding a "test set" in the context of clinical performance or a specific study designed to evaluate clinical outcomes. The document discusses "performance testing" related to biocompatibility and software validation, but these are not clinical studies with a test set of patients.

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. The document does not describe a study involving expert-established ground truth for a test set of clinical cases.

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

Not applicable. No such study or adjudication method is described.

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:

Not applicable. This device is an orthodontic appliance, not an AI-assisted diagnostic tool for human readers. No MRMC study is described.

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

Not applicable in the sense of an algorithm. The device itself is the physical orthodontic appliance. While it relies on a CAD/CAM system, the "standalone performance" of the device would refer to its clinical effectiveness, which is not detailed here. The software validation is mentioned but without performance metrics.

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

Not applicable in the context of clinical efficacy studies. For biocompatibility, the ground truth would be accepted ISO standards. For software validation, it would be the software's ability to meet its intended specifications, as per FDA guidance. No clinical ground truth (e.g., actual tooth movement measured against planned movement) is presented.

8. The sample size for the training set:

Not applicable. There is no mention of an AI model being trained with a specific dataset. The CAD/CAM system likely has its own development and validation protocols, but these are not detailed as a "training set" in a machine learning context.

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

Not applicable as there is no mention of a "training set" for an AI model.

Summary of what the document does state regarding performance/testing:

The document for the eCligner® primarily relies on substantial equivalence to an existing predicate device (Invisalign® System, K081960). It supports this claim by:

Indications for Use: Stating that the eCligner® is "a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition... intended for minor anterior tooth movement by way of continuous gentle force," which is compared to the predicate's "alignment of teeth during orthodontic treatment of malocclusion."
Technological Characteristics: Highlighting similarities in "design, mechanism of action and materials" (thermoplastic, gentle continuous pressure on teeth). Both systems use a 3D CAD/CAM system for digital planning and vacuum forming for production.
Performance Testing (Non-Clinical):
- Biocompatibility tests: Performed in accordance with ISO 10993 (cytotoxicity, irritation, sensitization). No results or specific acceptance criteria are provided in this document.
- Software validation test: For the CAD/CAM system, performed according to FDA guidance "Guidance for the content of premarket submissions for software contained in medical devices." A "performance qualification" was included, but no specific data, acceptance criteria, or results are detailed.

In essence, this 510(k) premarket notification establishes that the eCligner® is as safe and effective as the predicate device by demonstrating similar fundamental scientific technology and performance characteristics through non-clinical testing (biocompatibility, software validation) and comparison of intended use, design, and materials. It does not present a new clinical study with detailed acceptance criteria, patient sample sizes, or outcome measures to "prove" its efficacy beyond substantial equivalence.

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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three figures or lines representing the staff and intertwined snakes.

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

October 9, 2015

eClear International Co., Ltd. c/o Ms. April Lee Consultant WithUS Consulting 2531 Pepperdale Drive Rowland Heights, California 91748

Re: K143499 Trade/Device Name: eCligner® Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: II Product Code: NXC Dated: September 3, 2015 Received: September 9, 2015

Dear Ms. Lee:

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.

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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 (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.

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,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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Clear Internat

30 Teheranro 27 gil, Gangnam-gu, Seoul, Rep Tel. 82-2-515-5945 / Fax. 82-2-3443-9092

Indication for Use Statement

Indication for Use

K143499 510(K) Number (if known):

Device Name: eCligner®

Indication for Use:

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter _____________

(Part 21 CFR 801 Subpart D)

(Per 21 CFR 801 Subpart C)

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

For FDA Use Only

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Page 1 of 1

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eClearInternational Co.,L 30Teheranro27 gil,Gangnam-gu, Seoul,Republic ofKorea

Tel.82-2-515-5945/Fax.82-2-3443-9092

510(k) Summary

Submitter eClear International Co., Ltd. Dr. Tae Weon Kim 30 Teheranro 27 gilGangnam-gu Seoul, 135-915 Republic of Korea Email: info@ecligner.com Tel. +82-2-515-5945 Fax. +82-2-3443-9092

Official Correspondent

With US Group, Inc. April Lee 2531 Pepperdale Drive, Rowland Heights, CA 91748 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

Device Information

. Trade (Proprietary)Name: eCligner®
. Common Name: Aligners, Sequential
Classification Name: Orthodontic Plastic Bracket
Product Code: NXC
Panel: Dental
Regulation Number: 21 CFR872.5470
Device Class: ClassII
Date prepared:10/08/2015 ●

Predicate Device

Invisalign® System (K081960)

General Description

eCligner® is a transparent and removable orthodontic appliance.

eCligner® is a digitally- made Clear Aligner by the 3DCAD/CAM system. By printing the completed setup data into a series of plastic models, eCligne® is produced by a simple stamping procedure (Vacuum forming). eCligner® is designed for orthodontic tooth movement.

Each step for using orthodontic appliance, eCligner® consists of 3 weeks (1 week for soft, 1 week for medium and 1 week for hard) and wearing the appliance 17 hours a day for each sequence is required. * More than 3 weeks of wearing may be required per step depending on the direction of orthodontic treatment and dentist's instruction.

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eCligner® -H is used for 3 weeks during Final process.

During one individual step of treatment, three aligners of different layer thickness are worn in weekly intervals. The applied layer thicknesses are 0.5 mm (medium) and 0.75 mm (hard). Each individual step is consisting of three different thickness appliances as follows:

1. eCligner® -S (Soft)
1. eCligner® -M (Medium)
1. eCligner® -H (Hard)

*eCligner® -UH (Ultra Hard, 1.00mm) is used only for the patient with Bruxism (Teeth Grinding) since the aligner can be broken while the patient grinds their teeth unintentionally.

Indication for Use

eCligner® is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e.all second molars). The eCligner® is intended for minor anterior tooth movement by way of continuous gentle force.

Mechanism of Action

Each eCligner® exerts gentle force to achieve progressive realignmen to the teeth until the final correction has been attained.

Summary of Technological Characteristics

A dental health care professional (e.g. orthodontist or dentist), prescribes the eCligner 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, eCligner designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, eCligner produces the trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dentist who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the physician to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at anytime.

The technology is essentially identical to that used by a number of sequential alignment systems including the predicate device.

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Performance Testing

Biocompatibility tests such as cytotoxicity, irritation, and sensitization were performed in accordance with ISO 10993.

In addition, software validation test for CAD/CAM system used to fabricate this subject device was performed according to Guidance for Industry and FDA Staff, Guidance for the content of premarket submissions for software contained in medical devices. A performance qualification of the available software utilized in the processing steps of the subject device has been included to support substantial equivalence.

Comparison to the Predicate Devices

The subject device is substantially equivalent to the following predicate devices:

K081960, Invisalign system manufactured by Align Technology.

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Comparison to the Predicate Devices

	Subject Device	Predicate Device
Company Name	eClear International Co., Ltd.	ALIGNTECHNOLOGY
Device Name	eCligner®	INVISALIGNSYSTEM
510(k)Number	NA	K081960
Device ClassificationName	Aligner, Sequential	Aligner, Sequential
Classification ProductCode	NXC	NXC
Regulation Number	21 CFR872.5470	21 CFR872.5470
Indications for Use	eCligner® is a series ofclear, lightweight, plasticappliances indicated for thecorrection of dentalmalocclusion in patientswith permanent dentition(i.e.all second molars). TheeCligner® is intended forminor anterior toothmovement by way ofcontinuous gentle force.	The Invisalign system isindicated for the alignment ofteeth during orthodontictreatment of malocclusion.
Material	Thermoplastic	Thermoplastic
Design	Image: eCligner design	Image: Invisalign design
Mechanism of Action	Gentle continuous pressure onteeth	Gentle continuous pressure onteeth

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Substantial Equivalence Discussion

The eCligner® has a substantially equivalent intended use as the identified predicate. The subject device is similar in fundamental scientific technology to the predicate device in that they all have been designed, manufactured and tested in compliance with 21 CFR 872.5470.

The subject and predicate devices are similar in indications, design, mechanism of action and materials.

The difference between the subject device and the predicate device is the aligners with various layer thicknesses. The subject device needs three steps of treatment with 0.5 mm (soft), 0.62 mm (medium) and 0.75 mm (hard) thickness.

The verbiage of the Indications for Use of the subject device is slightly different than that of the declared predicates; however, these slight differences in wording does not change the intended use of the subject device has compared to the declared predicate.

Any differences in technology characteristics are accompanied by information that demonstrated the device is as safe and as effective as the predicate and do not raise different questions of safety and effectiveness than the predicate.

Conclusion

Testing to demonstrate the acceptability of the software utilized in the treatment planning steps has been included to support substantial equivalence. Based on the similarities of the two devices, it is concluded that the eCligner® is substantially equivalent to 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.