Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

Device Description

The Clear Aligner System consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state.

The Clear Aligners are fabricated by thin thermoformed polyurethane or thermoformed multilayer copolyester and polyurethane composite (TPU +PETG) plastic. The corrective forces are generated via differences between current teeth arrangement and each step's aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the "Clear Aligner," and summarizes the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain the detailed information requested regarding acceptance criteria and the study proving the device meets those criteria, specifically concerning performance metrics like sensitivity, specificity, or accuracy, which are typical for studies involving diagnostic AI/ML devices.

The document focuses on:

Biocompatibility testing
Software validation & risk analysis
Performance Testing of the traction accessory and shelf life
Real-world data for the traction accessory's effectiveness and adverse event analysis.

Based on the provided text, I can only extract information related to the non-clinical tests and their general acceptance criteria. There is no mention of a device that requires performance metrics against specific acceptance criteria like sensitivity/specificity or accuracy in the way described in your request. The device in question is a clear aligner for orthodontic treatment, not an AI/ML-driven diagnostic tool.

Therefore, many of your specific numbered requests cannot be directly answered from this document.

Here's an attempt to answer based on the available information, noting where information is missing:

1. A table of acceptance criteria and the reported device performance

Test Type	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Met requirements of study protocols; material considered non-cytotoxic, non-sensitizing, and not an intracutaneous irritant.	Results met the requirements of the study protocols; material is considered non-cytotoxic, non-sensitizing, and is not an intracutaneous irritant. (In compliance with ISO 10993)
Software Validation	Validated as per FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".	The software system used in the process of clear aligner manufacturing has been verified and validated as per FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".
Risk Analysis	Performed according to ISO 14971:2019.	A Risk Analysis was performed according to ISO 14971:2019.
Traction Accessory Strength	Met EA internal specifications and pre-defined acceptance criteria for shear and tensile strength.	The shear and tensile strength testing performed for the Angel button were tested according to EA internal specifications and the results passed the pre-defined acceptance criteria.
Shelf Life (Accelerated Aging)	Conformity with pre-established specifications and acceptance criteria for 3-year shelf life.	A 3-year shelf life accelerated aging testing were conducted and the test results showed conformity with the pre-established specifications and acceptance criteria.
Traction Accessory Effectiveness	Effective to aid the movement of teeth. (Implied, as based on "real-world data")	Real-world data was submitted to demonstrate that the traction accessory was effective to aid the movement of teeth.
Adverse Events	Low adverse event rate, specifically <0.001% since 2019 (Implied as supporting safety/effectiveness comparable to predicate)	An analysis of adverse events was provided that showed less than 0.001% of adverse events were occurred since 2019.

Missing Information for AI/ML-specific questions:

Given the nature of the device (a physical clear aligner), the following information typically found in AI/ML medical device submissions is not present in this document:

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

Not applicable as this is not an AI/ML diagnostic device with a "test set" in that context. The "real-world data" mentioned for traction accessory effectiveness is not detailed enough to provide this.

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.

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

Not applicable.

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.

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

Not applicable.

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

For the effectiveness of the traction accessory, "real-world data" was used, which generally implies outcomes data from patient treatments. The exact nature of this data (e.g., direct measurement of tooth movement, patient satisfaction, clinical assessments) is not specified.

8. The sample size for the training set

Not applicable. The "software" mentioned is for manufacturing and design, not an AI/ML algorithm that requires a training set in the diagnostic sense.

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

Not applicable.

Summary

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October 8, 2021

Wuxi EA Medical Instruments Technologies Limited. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 CHINA

Re: K203688

Trade/Device Name: Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: June 28, 2021 Received: September 08, 2021

Dear Ivy Wang:

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.

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) K203688

Device Name Clear Aligner

Indications for Use (Describe)

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Wuxi EA Medical Instruments Technologies Limited.

No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

510(K) Summary

K203688

Summary prepared date: 2021-10-06

A. Applicant:

Wuxi EA Medical Instruments Technologies Limited. Address: No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China Contact Person: Ms. Yan He Tel: +86 0510-83591717

Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com

B. Device:

Trade Name: Clear Aligner Common Name: Sequential Aligners Regulatory Information Classification Name: Aligner, Sequential Classification: Class II Product code: NXC Regulation Number: 21 CFR 872.5470 Review Panel: Dental

C. Predicate device:

K171674 Angel Align System Smile Development Corp.

Reference device K181739 Invisalign System with Mandibular Advancement Feature

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Align Technology, Inc.

D. Indications for use of the device:

Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).

E. Device Description:

The Proposed Device is an update device to the previous cleared Angel Align System (K171674) including added optional traction accessory.

The traction accessory, also called "Angel Button", made of thermoplastic polyurethane can be selected and will be bonded to the outer surface of the aligner by adhesive made of acrylic polyurethane.

F. Comparison to predicate device

The Clear Aligner is substantially equivalent in intended use, indications for use, mode of action, mode of use, design to the predicate Smile Angel Align (K171674). Only minor differences exist between the subject product and the predicate, which do not affect the safety or effectiveness of the subject device.

Table 1 provides a comparison of the subject and predicate device.

Table 1: Comparison to Predicate Device

Device	Subject Device	Predicate Device	Reference Device	Result
Manufacturer	Wuxi EA MedicalInstrumentsTechnologies Limited.	Smile DevelopmentCorp.	Align Technology,Inc.	-
510K number	K203688	K171674	K181739	-
Model Name	Clear Aligner	Angel Align System	Invisalign Systemwith MandibularAdvancementFeature	-
Classification	Class II Device, NXC(21 CFR 872.5470)	Class II Device, NXC(21 CFR 872.5470)	Class II Device, NXC(21 CFR 872.5470)	Same
Classification Name	Aligner, Sequential	Aligner, Sequential	Aligner, Sequential	Same
Indications for use	Clear Aligners are indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e. all second molars).	Angel Align System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.	The Invisalign System is intended for the orthodontic treatment of malocclusion	Same
Mode of Action	Orthodontic tooth movement occurs through forces applied by the device to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Orthodontic tooth movement occurs through forces applied by the device to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Orthodontic tooth movement occurs through forces applied by the device to the dentition as each tooth follows the programmed displacement based on a doctor's prescription.	Same
Anatomical Site of Use	Oral cavity	Oral cavity	Oral cavity	Same
Mode of Use	Each aligner is worn by the patient as determined by the treating dental practitioner, generally for 2 weeks prior to being replaced by the next aligner in sequence.	Each appliance is worn by the patient as determined by the dental practitioner, generally 2 weeks prior to being replaced by the next aligner in sequence.	Aligners are worn for approximately 1-2 weeks of 20-22 hours of wear per day, after which it is replaced by the next stage aligners. This is repeated for duration as prescribed by the Dental Practitioner	Same
Description of Appliance Application	Removable	Removable	Removable	Same
Method of manufacturing	Thermoforming	Thermoforming	Thermoforming	Same
Manufacturing Method	A digital model of the patient's teeth is created from either	A digital model of the patient's teeth is created from either	A digital model of the patient's teeth is created from	Same

	impression or directlyfrom an intraoral scanof the patient's teeth.From the digitalmodel, following adental practitioner'sprescription, thesoftware generatesmodel transformsdescribing theprovisional final,treated state andthen interpolates aseries of modeltransforms thatrepresentintermediate states ofalignment.The resultingcomputer "setups"relay this informationto rapid prototypingmachines thatproduce physicalpositive models. Thealigners are producedby thermoforming oneach physical modelto fabricate thesequence of aligners.	impressionordirectly from anintraoral scan of thepatient's teeth.From the digitalmodel, following adental practitioner'sprescription,software generatesmodel transformsdescribing theprovisional final,treated state andthen interpolates aseries of modeltransforms thatrepresentintermediate statesof alignment.The resultingcomputer "setups"relay thisinformation to rapidprototypingmachines thatproduce physicalpositive models. Thealigners areproducedbythermoforming oneach physical modeltofabricatethesequenceofaligners.	a PVS impressionor directly from anintraoral scan ofthe patient's teeth.From the digitalmodel, following adentalpractitioner'sprescription, thesoftware generatesmodel transformsdescribing theprovisional final,treated state andthen interpolates aseries of modeltransforms thatrepresentintermediate statesof alignment.Thecomputer "setups"relaythisinformationtorapid prototypingmachines thatproduce physicalpositive models.The alignersareproducedbythermoforming oneachphysicalmodel to fabricatethe sequence ofaligners.
Material	The clear aligner useseither1. Multilayerthermoformedcopolyesterandpolyurethanecompositeor2. Thermoformed	Thermoformedpolyurethane	The InvisalignSystem uses either:1. Multilayeraromaticthermoplasticpolyurethane/copolyester.or2. thermoformed	Same withthereferencedevice.
	polyurethane		polyurethane
Tractionaccessory	YesThermoformedpolyurethane	No	No	Different.Samematerial asaligner, nonewconcernsraised.
OTC or Rx	Rx	Rx	Rx	Same
Sterile	No	No	No	Same
Biocompatibility	In compliance withISO 10993	In compliance withISO 10993	In compliance withISO 10993	Similar.Both are incompliancewithISO10993

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Wuxi EA Medical Instruments Technologies Limited. No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

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No.1619, Huishan Avenue, Huishan Economic Development Zone, Wuxi, Jiangsu Province, China

G. Non-clinical Test

1) Biocompatibility Testing

The biocompatibility evaluation for the device was conducted in accordance with "Use of International Standard ISO 10993-1, Biological evaluation and testing within a risk management process -Guidance for Industry and Food and Drug Administration Staff" as recognized by FDA. The aligner is considered mucosal membrane contacting for a duration of greater than 30 days. The testing included the following tests:

Cytotoxicity
Irritation
Sensitization
Acute Toxicity
Subchronic toxicity
Genetic Toxicity

The results of the testing met the requirements of the study protocols and the material is considered non-cytotoxic, non-sensitizing and is not an intracutaneous irritant. The results of the studies further support a determination of substantial equivalence.

2) Software validation & risk analysis

The software system used in the process of clear aligner manufacturing has been verified and validated as per FDA Guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff".

A Risk Analysis was performed according to ISO 14971:2019 and documentation was included in the 510(k) to assess the performance and safety of subject device.

3) Performance Testing

Verification and validation testing were conducted to demonstrate the Clear Aligner showed conformity with pre-established specifications and acceptance criteria. The shear and tensile strength testing performed for the Angel button were tested according to EA internal specifications and the

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results passed the pre-defined acceptance criteria.

A 3-year shelf life accelerated aging testing were conducted and the test results showed conformity with the pre-established specifications and acceptance criteria.

H. Clinical Test Conclusion

Real-world data was submitted to demonstrate that the traction accessory was effective to aid the movement of teeth and that an analysis of adverse events was provided that showed less than 0.001 % of adverse events were occurred since 2019.

l. Conclusion

The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K171674.

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.