The UniSmile Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition. The UniSmile Clear Aligner System positions teeth by way of continuous gentle force.

Device Description

The UniSmile Clear Aligner System is fabricated of clear thin thermoformed plastics in a sequential series to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.

AI/ML Overview

This FDA 510(k) summary for the UniSmile Clear Aligner System does not contain details of an acceptance criteria study, nor a study proving the device meets specific performance criteria through clinical data or statistical analysis.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (ClearCorrect System, K113618) and a reference device (Orchestrate 3D, K181112) primarily through a comparison of:

Intended Use/Indications for Use: The UniSmile system is indicated for "treatment of tooth malocclusion in patients with permanent dentition" to "position teeth by way of continuous gentle force," which is stated to be "Same" as the predicate.
Technological Characteristics, Design, and Device Features: This includes comparisons of regulation number, common name, product code, device description, mode of action, anatomy location, size/dimension, method of manufacturing, material, material hardness, material tensile modulus, material tensile strength, and biocompatibility.

Here's a breakdown of the specific information requested, based on the provided document:

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

The document does not provide a table of acceptance criteria in terms of clinical outcomes (e.g., specific tooth movement percentages, treatment success rates, patient satisfaction scores) or quantitative engineering performance thresholds (beyond material properties).

Instead, the "acceptance criteria" appear to be implicit in the demonstration of substantial equivalence, where the UniSmile system's characteristics are deemed "Same" or "Similar" to the predicate device.

However, the document does provide information on material properties which can be considered "reported device performance" in a technical sense:

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (UniSmile Clear Aligner System)
Material	Thermoplastic copolyester
Material Hardness	80 ± 2 Shore D durometer
Material Tensile Modulus	Acceptable for an orthodontic base material
Material Tensile Strength	Acceptable for an orthodontic base material
Biocompatibility (ISO 10993-1 Assessment)	Passed, including Cytotoxicity, Intracutaneous Intradermal reactivity, Sensitivity

Note: The "acceptance criteria" for tensile modulus and strength are vaguely stated as "acceptable for as an orthodontic base material," rather than specific numerical thresholds.

Regarding the study that proves the device meets acceptance criteria:

The document does not describe a specific clinical study or an engineering performance study designed to prove the device meets pre-defined acceptance criteria for efficacy or overall clinical performance (e.g., ability to correct malocclusion in a patient population).

Instead, it relies on:

Material Testing: "Performance properties have been tested and approved for clear aligner applications." (pg 3)
Biocompatibility Testing: "Biocompatibility testing has been provided according to ISO-10993." (pg 3) This is further detailed in the comparison table (pg 5) as "Passed ISO 10993-1 assessment" including cytotoxicity, intracutaneous intradermal reactivity, and sensitivity.

These tests demonstrate the mechanical and biological safety of the materials used, but not the overall clinical effectiveness of the system in treating malocclusion.

Additional requested information (based on the provided text):

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

Not provided. The document does not describe a clinical "test set" in the context of human patients or clinical outcomes for the UniSmile system. The "test set" for material and biocompatibility testing is not specified in terms of sample size or provenance.

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/Not provided. No clinical "test set" requiring expert ground truth establishment for performance evaluation is described. The "ground truth" for material properties and biocompatibility would be based on validated laboratory standards and measurements, not expert consensus on clinical cases.

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

Not applicable/Not provided. No clinical "test set" requiring adjudication or consensus among experts 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/Not provided. This document describes a physical medical device (clear aligners) and a software (Orchestrate 3D) used for treatment planning, not an AI-assisted diagnostic or interpretative system where human reader performance would be a relevant metric. The software is used to design treatment plans, not to interpret cases or assist human readers in a diagnostic capacity.

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

Not applicable/Not provided. The UniSmile Clear Aligner System involves a series of physical clear aligners and a software for treatment planning. The aligners are worn by patients, and the treatment plan is designed by software but approved by a dental practitioner (human-in-the-loop). There is no "standalone algorithm" performance assessed in the context of interpretation or diagnosis in this document.

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

For material performance and biocompatibility, the "ground truth" is based on established ISO standards and laboratory testing protocols.
For the software (Orchestrate 3D), the "ground truth" for its function (treatment plan design) is implicitly tied to its equivalence to the predicate software and its established regulatory clearance (K181112), and ultimately the practitioner's approval. No independent "ground truth" for treatment plan accuracy from clinical outcomes is mentioned for this 510(k).

8. The sample size for the training set

Not applicable/Not provided. The document does not describe a "training set" in the context of machine learning or AI algorithm development for the UniSmile system or its associated software.

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

Not applicable/Not provided. As no training set is mentioned, the method for establishing its ground truth is not relevant here.

Summary

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January 30, 2020

Vitang Technology, LLC Xiangxu Chen Vice President of Regulatory and R&D 14662 Franklin Ave, Unit H Tustin, California 92780

Re: K191837

Trade/Device Name: UniSmile Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: October 25, 2019 Received: November 1, 2019

Dear Xiangxu Chen:

This letter corrects our substantially equivalent letter of January 29, 2020.

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 Srivinas '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) K191837

Device Name UniSmile Clear Aligner System

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
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☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Vitang Technology. The logo consists of a blue geometric shape resembling the letter 'T' on the left. To the right of the shape is the company name, 'Vitang Technology', with 'Technology' in a slightly lighter shade of blue. The text 'K191837' is at the top of the image.

Vitang Technology, LLC Traditional 510(k) Premarket Submission Vitang UniSmile Clear Aligner System

K191837

510(k)Summary

UniSmile Clear Aligner System

Submitter Name:	Vitang Technology LLC
Submitter Address:	14662 Franklin Ave, Unit H, Tustin, CA 92780
Phone Number:	773-236-7691
Contact Person:	Xiangxu Chen
Date Prepared:	1/29/2020
Device Trade Name:	UniSmile Clear Aligner System
Common Name:	Aligner, sequential
Classification Name:	Orthodontic Plastic Bracket
ClassificationNumber:	21 CFR 872.5470
Product Code:	NXC
Regulatory Class	2
Primary Predicate	K113618, ClearCorrect System
Reference Device	K181112, Orchestrate 3D
Device Description	The UniSmile Clear Aligner System is fabricated of clear thinthermoformed plastics in a sequential series to progressivelyreposition the teeth. Corrective force to reposition the teeth isdelivered via minor changes into a position in each subsequentaligner.
Indications for Use	The UniSmile Clear Aligner System is indicated for the treatment oftooth malocclusion in patients with permanent dentition. TheUniSmile Clear Aligner System positions teeth by way of continuousgentle force.
Summary of Usage	UniSmile Clear Aligner System consists of a series of clearplastic aligners that offer a solution for aesthetic orthodontictreatment by utilizing a set of removable aligners to incrementallymove the patient's teeth from an original state to a treated state thatcorrects tooth malocclusions.Cases are submitted by the dental professionals and images ofpatient teeth structures are transformed to three-dimensional data
Design andManufacturing Flowchart	This is a device that requires prescription by order of a dental practitioner. Based on the patient information from a dental practitioner, the treatment plan is designed with a software. The treatment plan is then forwarded to the dental practitioner for review. Once approved, the aligners are manufactured by thermal forming on digitally printed models. Clear aligners are delivered to the practitioner. Each aligner is used by the patient, with instructions.
	Page 2 of 4
	• Each aligner is designed for single use within a defined periodof time, such as 2 weeks/aligner.• It is not sterilized.• It does not contain drugs or biological substances.
Software	Software is used to design treatment plans. The software used withUniSmile Clear Aligner System is the Orchestrate 3D (K181112)software, version OrthoRx 4.
Clear AlignerMaterials Testing	Performance properties have been tested and approved for clearaligner applications.
Biocompatibility	Biocompatibility testing has been provided according to ISO-10993

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Image /page/4/Picture/0 description: The image contains the logo for Vitang Technology, along with the identifier K191837. The logo features a stylized letter 'T' in shades of blue, presented in a three-dimensional form. To the right of the 'T' is the company name, 'Vitang Technology,' with 'Vitang' in a darker blue and 'Technology' in a lighter blue hue.

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Image /page/5/Picture/0 description: The image contains the logo for Vitang Technology. The logo consists of a stylized blue "T" shape on the left and the words "Vitang Technology" in blue on the right. The word "Technology" is slightly smaller and a lighter shade of blue than the word "Vitang". There is also a serial number "K191837" at the top of the image.

Comparison with Predicate Device

	UniSmile ClearAligners	ClearCorrect System	Comparison
510(k) number	K191837	K113618
Regulation number	21 CFR 872.5470	21 CFR 872.5470	same
Devicecommon/classificationname	Aligner, sequential	Sequential Aligner	same
Product Code	NXC	NXC
Indications for use	The UniSmile Clear AlignerSystem is indicated for thetreatment of toothmalocclusion in patients withpermanent dentition. TheUniSmile Clear AlignerSystem positions teeth byway of continuous gentleforce.	The ClearCorrect System isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e. all secondmolars). The ClearCorrectSystem positions teeth byway of continuous gentleforce.	Same
Device Description	The UniSmile Clear AlignerSystem is fabricated of clearthin thermoformed plastics ina sequential series toprogressively reposition theteeth. Corrective force toreposition the teeth isdelivered via minor changesinto a position in eachsubsequent aligner.	The ClearCorrect deviceis fabricated of clear thinthermoformedpolyurethane plastic in asequential series toprogressively repositionthe teeth. Correctiveforce to straighten theteeth is delivered viaminor changes into aposition in each subsequentaligner.	Same
Mode of Action	A set of removable alignersincrementally move the	Orthodontic toothmovement occurs	Same
	patient's teeth from anoriginal state to a treatedstate through forces appliedby the appliance that correctstooth malocclusions. Theprogrammed displacement isbased on a doctor'sprescription.	through forces applied bythe appliance to thedentition as each toothfollows the programmeddisplacement based on adoctor's prescription.
Anatomy Location	Mouth, mucosal membranes	Mouth, mucosal membranes	Same
Size/Dimension	Patient and treatmentprogress specific	Patient and treatmentprogress specific	Same
Method ofManufacturing	Thermoforming	Thermoforming	Same
Material	Thermoplastic copolyester	Thermoplastic polyurethane	Similar. Both arethermoplasticformingmaterials that donot raise anyadditionalquestions of safetyor efficacy
Material Hardness	$80 \pm 2$ Shore D durometer	$80 \pm 2$ Shore D durometer	Same
Material TensileModulus	Tensile modulus isacceptable for as anorthodontic base material	Information not available	Good fororthodontic clearalignerapplications
Material TensileStrength	Tensile strength is acceptablefor as an orthodontic basematerial	Information not available	Good fororthodontic clearalignerapplications
Biocompatibility	Passed ISO 10993-1assessment• Cytotoxicity• Intracutaneus Intradermalreactivity• Sensitivity	Passed ISO 10993-1asseessment• Cytotoxicity• Intracutaneus Intradermalreactivity	Same

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Image /page/6/Picture/0 description: The image contains the text "K191837" at the top. Below that is a logo for "Vitang Technology". The logo consists of a blue geometric shape resembling a stylized letter "T" on the left, followed by the company name in blue font, with the "ec" in "Technology" being a lighter shade of blue.

Conclusion of Substantial Equivalence

UniSmile Clear Aligner System have substantially equivalent Indications for Use as the identified predicate and reference devices. UniSmile Clear Aligner System are substantially equivalent to the predicate device in the technological characteristics, design and device features.

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.