The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.

Device Description

The Custom-made Invisible Aligners System is a series of dental aligners that fabricated of clear, thin thermoformed plastic to progressively reposition the teeth. The product is made from a composite multilayer material with thermoplastic polyurethane and polyethylene terephthalate-1, 4-cyclohexanedimethanol ester (TPU+PETG). Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner. They are designed to move the teeth to the target position and deliver desired clinical effect.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Custom-made Invisible Aligners." This document describes the device, its intended use, comparison to predicate devices, and the non-clinical testing performed to establish substantial equivalence.

However, the 510(k) summary explicitly states:
"H. Clinical Test Conclusion: No clinical study is included in this submission."

Therefore, based on the provided text, there is no information available regarding acceptance criteria based on clinical performance, nor any study proving the device meets such criteria through human clinical data. The document focuses solely on non-clinical testing to demonstrate performance and safety.

Even though the request asks for specific details about the study that proves the device meets the acceptance criteria, the provided document does not contain this information because no clinical studies were performed or included in the submission.

To directly address the request while accurately reflecting the content of the document:

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

Based on the non-clinical testing described, the acceptance criteria relate to material properties, manufacturing accuracy, and biocompatibility.

Acceptance Criteria Category	Specific Test/Property	Acceptance Criteria (Implied/Directly Stated)	Reported Device Performance
Performance Testing	Thickness, appearance, odor, density, water absorption, dissolution, color stability, tear resistance, Tensile modulus of elasticity	Compliance with pertinent standards and specifications, expectations of the dental community, and product labeling	Device is in compliance and demonstrates effectiveness. Results showed conformity with pre-established specifications and acceptance criteria.
Manufacturing Accuracy	3D molding and aligner molding accuracy	Meet pre-established specifications	Checked for aligners from 12 different patient cases (beginning, middle, end of sequence); met pre-established specifications.
	Suitability, function, and form of the aligner	Complied with pre-established specifications and acceptance criteria when compared to treatment design in software.	Results complied with pre-established specifications and acceptance criteria.
Shelf Life	Performance after accelerated aging (3 years shelf life)	Conformity with pre-established specifications and acceptance criteria	Test results after 81 days of accelerated aging (at 60°C) showed conformity.
Biocompatibility	Cytotoxicity	Non-toxic	Met requirements of study protocols; considered non-toxic.
	Irritation	Not an intracutaneous irritant	Met requirements of study protocols; considered not an intracutaneous irritant.
	Sensitization	Non-sensitizing	Met requirements of study protocols; considered non-sensitizing.
	Sub chronic systemic toxicity	Met requirements of study protocols (implies no significant toxicity)	Met requirements of study protocols.
	Genotoxicity	Met requirements of study protocols (implies no genotoxic effects)	Met requirements of study protocols.
Software V&V	Functionality, safety, effectiveness	Device is as safe and effective as the predicates	Documentation provided as recommended by FDA guidance; "moderate" level of concern.

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

Sample Size: For manufacturing accuracy validation, aligners from "12 different patient case" were evaluated. No other specific sample sizes are mentioned for the general performance or biocompatibility testing (e.g., number of material samples for tensile strength).
Data Provenance: Not explicitly stated, but the applicant (Zhejiang Yinchili Medical Technology Co., Ltd.) is based in China, suggesting the testing was likely conducted in China or by labs contracted by a Chinese company.
Retrospective/Prospective: Not applicable, as these were non-clinical bench and lab tests, not clinical studies involving patients.

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 non-clinical tests is established by adherence to recognized standards (e.g., ISO 10993) and pre-established specifications, not by expert consensus on clinical findings.

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

Not applicable. Adjudication methods like 2+1 are used in clinical studies for interpretation of results, especially imaging. This document describes non-clinical testing.

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. The document explicitly states, "No clinical study is included in this submission." This device is a physical medical device (aligners), not an AI-based diagnostic or assistive software.

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

No. This section is generally relevant for AI/ML devices. The device described is a physical aligner. While there is software for ordering/processing, its V&V focused on its function in facilitating the device, not its standalone diagnostic performance.

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

For material performance and manufacturing accuracy: Ground truth was established by pre-established specifications, engineering principles, and compliance with recognized standards (e.g., ISO for biocompatibility).
For biocompatibility: Ground truth was based on the results of specific biological tests (cytotoxicity, irritation, sensitization, sub chronic systemic toxicity, genotoxicity) interpreted against the requirements of ISO 10993.

8. The sample size for the training set:

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set of data.

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

Not applicable (see point 8).

Summary

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April 17, 2023

Zhejiang Yinchili Medical Technology Co., Ltd. % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China

Re: K223454

Trade/Device Name: Custom-made Invisible Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 16, 2023 Received: January 17, 2023

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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE., CQIA 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) K223454

Device Name Custom-made Invisible Aligner

Indications for Use (Describe)

The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligners positions teeth by way of continuous gentle force.

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

(As requirement by 21 CFR 807.92)

A. Applicant:

Zhejiang Yinchili Medical Technology Co., Ltd. Address: North 4F, No.239 Yatai Road, Nanhu District, Jiaxing, Zhejiang, CHINA Contact Person: Ms. Xinyan Zhang Tel: +86- 15800780940 Email: zhangxinyan@smartee.cn Date of summary prepared: 2023-03-30

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: Custom-made Invisible Aligners Common Name: Sequential Aligners Model: YCL-C Regulatory Information Classification Name: Aligner, Sequential Classification: Class II Product code: NXC Regulation Number: 21 CFR 872.5470 Review Panel: Dental

C. Predicate device:

K203624 (Primary Predicate) Custom-made Invisible Aligners Zhejiang Yinchili Medical Technology Co., Ltd.

Reference device K181739 Invisalign System with Mandibular Advancement Feature Align Technology, Inc.

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K223454

D. Indications for use of the device:

E. Device Description:

F. Comparison to predicate device

The Custom-made Invisible Aligners is substantially equivalent in intended use, indications for use, mode of action, mode of use, design, and manufacturing to the predicate device. 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: Comparison to Predicate Device
Device	Subject Device	Predicate Device	Reference Device	Result
510K number	K223454	K203624	K181739	-
Model Name	Custom-made InvisibleAligners	Custom-madeInvisible Aligners	Invisalign Systemwith MandibularAdvancementFeature	-
Classification	Class II Device, NXC (21CFR 872.5470)	Class II Device, NXC(21 CFR 872.5470)	Class II Device, NXC(21 CFR 872.5470)	Same
ClassificationName	Aligner, Sequential	Aligner, Sequential	Aligner, Sequential	Same
Indications foruse	The Custom-madeInvisible Aligners isindicated for thetreatment of toothmalocclusion inpatients withpermanent dentition(i.e., all second molars).The Custom-madeInvisible Alignerpositions teeth by wayof continuous gentle	The Custom-madeInvisible Aligners isindicated for thetreatment of toothmalocclusion inpatients withpermanent dentition(i.e., all secondmolars). TheCustom-madeInvisible Alignerpositions teeth by way	The InvisalignSystem is intendedfor the orthodontictreatment ofmalocclusion.	Same
	force.	of continuous gentle force.
Mode ofAction	Orthodontic toothmovement occursthrough forces appliedby the device to thedentition as each toothfollows theprogrammeddisplacement based ona doctor's prescription.	Orthodontic toothmovement occursthrough forcesapplied by the deviceto the dentition aseach tooth follows theprogrammeddisplacement basedon a doctor'sprescription.	Orthodontic toothmovement occursthrough forcesapplied by thedevice to thedentition as eachtooth follows theprogrammeddisplacementbased on a doctor'sprescription.	Same
AnatomicalSite of Use	Oral cavity	Oral cavity	Oral cavity	Same
Mode of Use	Each aligner is worn bythe patient asdetermined by thetreating dentalpractitioner, generallyfor 22 hrs/day (or fulltime except for eatingand hygiene) for 2weeks prior to beingreplaced by the nextaligner in sequence.This is repeated for aduration as prescribedby a DentalProfessional.	Each aligner is worn bythe patient asdetermined by thetreating dentalpractitioner, generallyfor 22 hrs/day (or fulltime except for eatingand hygiene) for 2weeks prior to beingreplaced by the nextaligner in sequence.This is repeated for aduration as prescribedby a DentalProfessional.	Aligners are wornfor approximately1-2 weeks of 20-22hours of wear perday, after which itis replaced by thenext stage aligners.This is repeated forduration asprescribed by theDental Practitioner	Same
Application	Removable	Removable	Removable	Same
Raw MaterialUsed	Multilayer(Thermoplasticpolyurethane) + PETG(Polyethyleneterephthalate-1,4-cyclohexanedimethanol ester)	TPU Thermoplasticcopolyester(polyethyleneterephthalate-ethylene glycol copolyester)	The InvisalignSystem uses either:1. Multilayeraromaticthermoplasticpolyurethane/copolyester.or2. thermoformedpolyurethane	Samewith thereferencedevice.
Method ofManufacturing	Thermoforming	Thermoforming	Thermoforming	Same
OTC or Rx	Rx	Rx	Rx	Same
Sterile	No	No	No	Same
Biocompatibility	In compliance with ISO 10993, tests includingCytotoxicityOral Mucosa IrritationSensitizationSub chronic systemic toxicityGenotoxicity	In compliance with ISO 10993, tests includingCytotoxicityOral Mucosa IrritationSensitization	In compliance with ISO 10993	Similar.Both are in compliance with ISO 10993
Design	Image: Clear aligner	Image: Clear aligner	Not available	Similar.Both are transparent plastic films.

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

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K223454

G. Non-clinical Test

1) Performance Testing

Bench testing has demonstrated that the device is in compliance with pertinent standards and specifications, the expectations of the dental community and the product labeling. Performance testing was performed to the subject device including thickness, appearance, odor, density, water absorption, dissolution, color stability, tear resistance, Tensile modulus of elasticity to demonstrate its effectiveness.

Manufacturing validation accuracy testing

Manufacturing accuracy validation were conducted to the Custom-made Invisible Aligners. Aligners from 12 different patient case were evaluated at the beginning, middle and end throughout the sequence. The accuracy of 3D molding and aligner molding are checked and meet the pre-established specification. The suitability, function and form of the aligner were checked and comparing it to the treatment design in the software, and the results were complied with the pre-established specifications and acceptance criteria.

Shelf life – 3 years

A 3-year shelf life was determined by accelerated aging testing. Performance testing were conducted after 81 days of accelerated aging under 60°C. The test results showed conformity with the pre-established specifications and acceptance criteria.

2) 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

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K223454

Sensitization
Sub chronic systemic toxicity
Genotoxicity

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

Software Verification and Validation Testing

Software verification and validation testing were conducted on the software that facilitates ordering and processing of the Custom-made Invisible Aligner to support that the device is as safe and effective as the predicates. Documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.

H. Clinical Test Conclusion

No clinical study is included in this submission.

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 K203624.

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.