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. This is generally done using an oral scan data or a physical impression by a dental health professional (e.g. clinician). This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning. The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor 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. 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 document is a 510(k) Pre-market Notification from the FDA for a device called "Clear Aligner." It describes the device, its intended use, and provides information on non-clinical studies performed to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Key Takeaways:

This submission focuses on establishing substantial equivalence to an existing predicate device rather than proving de novo clinical efficacy.
The primary study described is a manufacturing validation to ensure the aligner adheres to dimensional and rotational precision during its creation, which is crucial for its intended function.
No human-in-the-loop or standalone algorithm performance studies are described as this is a physical medical device (aligner) primarily manufactured using a digital process, not an AI or software algorithm that analyzes patient data to output a diagnosis or treatment plan recommendation. The software mentioned (3Shape Ortho System™ Software) is used for the manufacturing process, not for diagnostic interpretation.
No clinical studies were performed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Pre-established Tolerances)	Reported Device Performance
All translational measurements within 0.3mm of the target input value.	All translational measurements were within 0.3mm of the target input value. (Met)
All rotational measurements within 3 degrees of the target input value.	All rotational measurements were within 3 degrees of the target input value. (Met)
Biocompatibility with ISO 7450, ISO 10993-1, ISO 10993-5, and ISO 10993-10.	The Zendura plastic sheet material used in the Clear Aligner has been tested and shown to be compliant with ISO 7450, ISO 10993-1, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation and skin sensitization). (Met via material testing)

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

Sample Size: The document does not specify an exact numerical sample size for the manufacturing validation study. It states that "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 multiple measurements were taken across these aspects, but the specific number of units, models, or measurements is not provided.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the study is a non-clinical manufacturing validation, meaning it would typically involve controlled laboratory testing rather than patient data.

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

This section is not applicable as the ground truth for this non-clinical manufacturing validation was not established by human experts. Instead, the ground truth was the "target input value" derived from the treatment planning software, and measurements were compared against this engineering specification.

4. Adjudication method for the test set

Not applicable. There was no human adjudication process described for the manufacturing validation. The comparison was against objective numerical tolerances (0.3mm for translation, 3 degrees for rotation).

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. An MRMC comparative effectiveness study was not performed. The device is a physical aligner, and this submission focuses on its manufacturing precision and biocompatibility, not on an AI algorithm that assists human readers/diagnosticians.

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

No. This is not an AI or software device that performs standalone interpretations or recommendations. The software (3Shape Ortho System™ Software) is used for the manufacturing process of the physical aligner, not for standalone diagnostic performance.

7. The type of ground truth used

For the manufacturing validation, the ground truth was the predefined "target input value" (engineering specifications) for translational and rotational movements as determined by the treatment planning software. This is a form of engineering specification/design ground truth.
For biocompatibility, the ground truth was compliance with international standards (ISO).

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." The manufacturing process validation does not involve machine learning model training.

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

Not applicable. As there is no training set, this question is irrelevant.

Summary

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January 8, 2020

Royal Dental Lab % Becky Chen Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No.22 Guimiao Rd., Shenzhen, Guangdong, 518000 P.R.China

Re: K192767

Trade/Device Name: Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 26, 2019 Received: September 30, 2019

Dear Becky Chen:

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 mediation-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 "Nandu" Nandkumar, Ph.D. 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) K192767

Device Name Clear Aligner

Indications for Use (Describe)

This device is indicated for use in the alignment teeth through orthodontic treatment of misalignment 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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K192767 - 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:	Royal Dental Lab
Address:	F/1, 2, 3, 5, 6, Building 2, No. 4 West Area, Shangxue IndustryPark, Bantian, Longgang, Shenzhen, Guangdong, China
Contact person:	Fiona
Phone number:	+86-0755-89501914
Fax number:	+86-0755-89501749
Email:	fiona@china-dental.com
Date of summary prepared:	2019.09.26

(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 Aligner
Common name	Aligner, sequential
Regulation name:	Orthodontic plastic bracket
Regulation number: Product	21 CFR 872.5470
code	NXC
Review panel: Regulation	Dental
class:	Class II

(4) Primary Predicate

Sponsor	Smylio, Inc.
Device Name and Model	Smylio Invisible Clear Aligners
510(k) Number	K173784
Product Code	NXC
Regulation Number	21 CFR 872.5470
Regulation Class	II

(5) Reference device

This reference device - 3Shape Ortho System ™ is the software which used for the manufacturing

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

process of Clear Aligner.

(6) Description/ Design of device

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. This is generally done using an oral scan data or a physical impression by a dental health professional (e.g. clinician). This scanned data (digital CAD/CAM models or patient models) are imported into specialized dental software for treatment planning.

The second step is the printing of 3D models of the treatment plan for use in step 3 (thermoforming). In the second step, the doctor 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.

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).

(7) Intended use/ Indications for use

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

(8) Materials

Component ofDevice Requiring	Material ofComponent	Body Contact Category(ISO 10993-1)	Contact Duration(ISO 10993-1)
----------------------------------	--------------------------	----------------------------------------	-----------------------------------

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Biocompatibility
plastic sheetmaterial	Co-polyester orCo-polymer	Surface-contacting device:Mucosal membrane	< 24 hours

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	Predicate device	Remark
Trade name	Clear Aligner	Smylio Invisible Clear Aligners	/
510 (k) number	K192767	K173784	/
Regulation number	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 for use/ Intended use	This device is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.	Smylio Invisible Clear Aligners is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.	Same
Prescription or OTC	Prescription Use	Prescription Use	Same
Materials	Co-polyester or Co-polymer	Co-polyester or Co-polymer	Same
Mode of Action	Continuous gentle force applied to teeth to achieve movement.	Continuous gentle force applied to teeth to achieve movement.	Same
Manufacturing method	Thermoforming	Thermoforming	Same
Device description	Sequential thermoformed plastic aligner	Sequential thermoformed plastic aligners	Same
Patient Removable?	Yes	Yes	Same
Duration of Use	20-22 hours per day	20-22 hours per day	Same
Biocompatibility	Passed the tests as per ISO 10993-5 and ISO 10993-10 (Cytotoxicity, sensitization, irritation)	Passed the tests as per ISO 10993-5 and ISO 10993-10 (Cytotoxicity, sensitization, irritation)	Same
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

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Conclusion:

The only difference between the subject and predicate devices are the manufacturer and distributor of the device. Based on the above analysis, the Clear Aligner is substantial equivalent to the predicate device.

(10) Non-clinical studies and tests performed

Non-clinical testings 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 difference 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:

ISO 7450: 2008, Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
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 Cytotoxicity
ISO 10993-10, Biological Evaluation Of Medical Devices Part 10: Tests For Irritation And A Skin Sensitization

(11) Clinical studies and tests performed

Clinical studies and tests were not conducted.

(12) Conclusion

Based on the above analysis and tests performed, it can be concluded that the performance and function of Clear Aligner are normal, and it is Substantially Equivalent (SE) 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.