The Clear Aligner is intraoral thermoformed plastic aligner that worn 20 to 22 hours per day and is designed to be used in a sequence, each aligner providing a gentle continuous force, to allow for the movement of teeth to the final desired position. The aligner is to be removed for eating and for cleaning.

Clear Aligner is fabricated using a three-step process.

The first step is to obtain the dimensions and details of the patient's baseline dentition from the prescribing clinician who takes impressions or scans of the patient's teeth and sends them to the lab. The scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.

The second step is to sent the treatment plan to the dentist for review and approval, then print the 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, we utilizes a software application to plan the treatment by creating a series of sequential models that gradually position the teeth into their final desired position. A 3D printer is used to create the molds needed for each treatment step to provide the surface around which the aligner is thermoformed.

The final step is the thermoforming of a plastic sheet material to each of the sequential treatment steps. This process is done using a standard thermoforming equipment and the appropriate material as outlined in this submission. And the thermoformed aligners are sent back to the dentist for distribution to the patient in sequential stages and that the dentist checks the aligners for fit and function and monitors the treatment from the first aligner until treatment is completed.

Specialized orthodontic CAD/CAM software will be used to develop the treatment plans and to produce standard 3D printer files that will facilitate the manufacturing of each sequential aligner in the treatment plan. The software application used for the manufacturing validation is this submission is the 3Shape Ortho System ™ Software which have 510(k) (K152086).

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Clear Aligners). While it details non-clinical studies and testing, it explicitly states that no clinical studies or tests were conducted (Section 11). This means the information requested regarding a multi-reader multi-case (MRMC) comparative effectiveness study, standalone algorithm performance, or the establishment of ground truth for training/test sets based on expert consensus or pathology data is not applicable and not present in this document.

The document focuses on demonstrating substantial equivalence to a predicate device primarily through non-clinical performance testing related to manufacturing validation and biocompatibility.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and reported device performance

The document contains a table comparing the subject device to a predicate device, but it's not a table of acceptance criteria and reported performance in the traditional sense of a clinical or AI study. Instead, the "acceptance criteria" for the manufacturing validation are described in the text.

Manufacturing Validation Acceptance Criteria & Performance:

Acceptance Criteria	Reported Device Performance
All translational measurements within 0.3mm of target input value	All translational measurements were within 0.3mm of the target input value.
All rotational measurements within 3 degrees of target input value	All rotational measurements were within 3 degrees of the target input value.
No statistical differences in the intended and measured values observed from any of the groups	There were no statistical differences in the intended and measured values observed from any of the groups. (Implicitly met based on the above)

2. Sample size used for the test set and the data provenance

Test set sample size: Not explicitly stated as a numerical count of aligners or patients. The text mentions "Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner." This implies a set of these items were tested, but no specific quantity is given.
Data provenance: Not specified. It's implied this was internal testing performed by the manufacturer. The location of the test (if external) is not mentioned beyond the manufacturer's address in Shenzhen, China. The document does not specify if the data was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for the manufacturing validation was established by measurements against target input values using "an independent 3rd party software and digital calipers," not by human expert assessment.

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

Not applicable, as the ground truth was based on physical measurements, not human interpretation requiring adjudication.

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 MRMC study was done. The document explicitly states: "Clinical studies and tests were not conducted." (Section 11)

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

This device (Clear Aligner) is a physical medical device, not an AI algorithm. The 3Shape Ortho System™ Software is mentioned as a reference device used in the manufacturing process (for treatment planning and generating 3D printer files), but no performance study of this software itself (standalone or otherwise) is presented in this 510(k) summary for the Clear Aligner. The manufacturing validation assessed the output of the process that uses the software, not the software's performance as an AI system.

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

The ground truth for the manufacturing validation was target input values from the treatment plan, against which physical measurements of the produced aligners/molds were compared. These are physical measurement standards.

8. The sample size for the training set

Not applicable. This document describes the validation of a manufactured medical device, not the training of an AI model.

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

Not applicable, as there was no AI model training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 27, 2021

Shenzhen Yinuo Dental Technology Co.LTD % Gamma Zhang RA Manager Feiving Drug&Medical Consulting Technical Service Group Rm 218, Building 2, Yike Intelligent Innovation Park, No. 232 Kezhu Road, Huangpu, Guangzhou Guangzhou, Guangdong 510000 China

Re: K210373

Trade/Device Name: Clear Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: July 13, 2021 Received: July 19, 2021

Dear Gamma Zhang:

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

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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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K210373

Device Name Clear Aligners

Indications for Use (Describe)

This device is indicated for use in the alignment of all permanent dentition through orthodontic treatment and malocclusion.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) Summary

This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.

(1) Applicant information

510 (k) owner's name:	Shenzhen Yinuo Dental Technology Co.LTD
Address:	Xinfeng Industry Park No.11,101-301, Xintian Community, Guanhu Street, Longhua, Shenzhen, Guangdong, China
Contact person:	Fiona
Phone number:	+86-755-2876 1139
Email:	fiona@hkloyalbeauty.com
Date of summary prepared:	2021-07-13

(2) Reason for the submission

New device, there were no prior submissions for the device.

(3) Proprietary name of the device

Trade name/Model:	Clear Aligners
Common name	Aligner, sequential
Regulation name:	Orthodontic plastic bracket
Regulation number:	21 CFR 872.5470
Product code	NXC
Review panel:	Dental
Regulation class:	Class II

(4) Predicate device
Sponsor	Royal Dental Lab
Device Name and Model	Clear Aligners
510(k) Number	K192767
Product Code	NXC
Regulation Number	21 CFR 872.5470

(5) Reference device

Regulation Class

This reference device - 3Shape Ortho System ™ is the software which used for the manufacturing process of Clear Aligner.

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Sponsor	3Shape A/S
Device Name and Model	3Shape Ortho SystemTM Software
510(k) Number	K152086
Product Code	PNN, LLZ
Regulation Number	21 CFR 872.5470
Regulation Class	II

(6) Description/ Design of device

Clear Aligner is fabricated using a three-step process.

(7) Intended use/ Indications for use

This device is indicated for use in the alignment of all permanent dentition through orthodontic treatment of misalignment and malocclusion.

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Component ofDevice RequiringBiocompatibility	Material ofComponent	Body Contact Category(ISO 10993-1)	Contact Duration(ISO 10993-1)
plastic sheetmaterial	Co-polyester orCo-polymer	Surface-contacting device:Mucosal membrane	Permanent durationcontact devices (>30days)

(8) Materials

The body-contacting material (plastic sheet material) used in Clear Aligner has passed biocompatibility tests. Details can be seen in "Biocompatibility Discussion".

(9) Technological characteristics and substantial equivalence

Item	Subject device	Primary Predicate device	Remark
Trade name	Clear Aligner	Clear Aligner	/
510 (k) number	/	K192767	/
Regulationnumber	21 CFR 872.5470	21 CFR 872.5470	Same
Regulation name	Orthodontic plastic bracket	Orthodontic plastic bracket	Same
Product code	NXC	NXC	Same
Class	II	II	Same
Indications foruse/ Intended use	This device is indicated foruse in the alignment of allpermanent dentitionthrough orthodontictreatment of misalignmentand malocclusion.	This device is indicated foruse in the alignment ofpermanent teeth throughorthodontic treatment ofmisalignment andmalocclusion.	Similar. Note 1
Prescription orOTC	Prescription Use	Prescription Use	Same
Materials	Co-polyester or Co-polymer	Co-polyester orCo-polymer	Same
Mode of Action	Continuous gentle forceapplied to teeth to achievemovement.	Continuous gentle forceapplied to teeth to achievemovement.	Same
Manufacturingmethod	Thermoforming	Thermoforming	Same
Devicedescription	Sequential thermoformedplastic aligner	Sequential thermoformedplastic aligner	Same
PatientRemovable?	Yes	Yes	Same
Duration of Use	20-22 hours per day	20-22 hours per day	Same
Biocompatibility	Passed the tests as per ISO10993-5 and ISO 10993-10	Passed the tests as per ISO10993-5 and ISO 10993-10	Same

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	(Cytotoxicity, sensitization, irritation)	(Cytotoxicity, sensitization, irritation)
Sterility	Non-sterile	Non-sterile	Same
Anatomical site	Used by dentist or orthodontist on teeth for dental patients.	Used by dentist or orthodontist on teeth for dental patients.	Same

Note 1: The indications for use of subject device is similar to the predicate device, but the indications for use of subject device is in the range of predicate device, so the difference does not affect the effectiveness and safety of the subject device.

Conclusion:

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K2103734, Clear Aligner is as safe, as effective, and performs as well as the legally marketed predicate device cleared under K192767.

(10) Non-clinical studies and tests performed

Non-clinical tests have been conducted to verify that the Clear Aligner meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device.

Manufacturing Validation

A manufacturing validation was performed to demonstrate the manufacturing process for Clear Aligner. Three critical aspects of the manufacturing process were assessed: digital dentition models from treatment planning, 3D printed molds, and the final thermoformed aligner.

An independent 3rd party software and digital calipers were used to perform point-to-point and critical displacement measurement.

All translational measurements were within 0.3mm of the target input value and all rotational measurements were within 3 degrees of the target input value, the predefined tolerance of the manufacturing process. There were no statistical differences in the interence in the intended and measured values observed from any of the groups. This test has met the pre-established acceptance criteria.

Biocompatibility

A biocompatibility discussion was conducted. The Clear Aligner uses the Zendura plastic sheet material and this material has been tested and shown to be compliant with the following standards:

A ISO 7450: 2008, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
A ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-5, Biological Evaluation of Medical Devices -- Part 5: Tests For InVitro A Cytotoxicity

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ISO 10993-10, Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization

(11) Clinical studies and tests performed

Clinical studies and tests were not conducted.

(12) Conclusion

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.