The Argen Clear Aligner and Argen Clear Aligner Premium are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

Device Description

The Argen clear aligners are comprised of series of clear plastic removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. A dental health professional (e.g. orthodontist or dentist) prescribes the Argen Clear Aligner or the Argen Clear Aligner Premium based on an assessment of the patient's teeth. The dental health professional (dentist/orthodontist) takes intraoral scans or physical impressions of the patient's teeth, determines a course of treatment with the system, and completes a prescription form using a standard dental software used for tooth alignment. The series of plastic trays are designed in accordance with the physician's prescription using standard dental software for planning the tooth alignment. The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by 3Shape A/S (K180941). It is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring, analyzing, inspecting and visualizing 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances based on 3D scanned orthodontic models. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, Argen produces trays, which are formed of clear, thin, thermoformed plastic. The trays are provided to the dental health care professional who provides them to the patient, confirming fit and design. The thermoplastic materials used in the manufacture of the Argen aligners are similar to the materials commonly used in many dental and orthodontic appliances including clear aligners. The Argen Clear Aligner is made of a thermoplastic polyurethane resin and the Argen Clear Aligner Premium is made of a thermoplastic polyurethane-polyester composite resin.

AI/ML Overview

The provided text describes the "Argen Clear Aligner" and "Argen Clear Aligner Premium" devices. These are orthodontic devices, and the information is from an FDA 510(k) summary, which focuses on substantial equivalence to predicate devices rather than detailed performance studies for AI/software components as would be described for diagnostic AI tools.

Therefore, many of the requested details, such as specific acceptance criteria related to diagnostic performance metrics, sample sizes for test sets (in the context of AI models), number of experts, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for AI performance, are not applicable for this type of medical device submission.

This document describes a physical medical device (clear aligners) and its manufacturing process, incorporating a software system (Ortho Analyzer) for treatment planning and design. The "performance data" referred to in Section VII of the 510(k) summary (page 3) relates to physical properties and biocompatibility testing, and verification and validation activities to ensure consistency between the aligner series' design and manufactured aligners. This is distinct from the performance evaluation of a diagnostic AI algorithm.

Here's a breakdown of the requested information based on the provided text, indicating where information is not applicable or not provided:

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

The document does not explicitly state acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) because it's not a diagnostic AI device. The "acceptance criteria" mentioned refer to the manufacturing and design consistency of the physical aligners.

Acceptance Criteria (General)	Reported Device Performance (Summary)
Material Properties:	Thermoplastic polyurethane resin (Argen Clear Aligner) and thermoplastic polyurethane-polyester composite resin (Argen Clear Aligner Premium) are similar to materials commonly used in many dental and orthodontic appliances, including clear aligners. Biocompatibility shown to meet requirements (referenced from predicate device submissions).
Manufacturing Consistency:	Verification and validation activities were assessed on the proposed device to ensure consistency between the aligner series' design and manufactured aligners. The results show the proposed device met all pre-defined acceptance criteria (specific criteria are not detailed in this summary, but would typically relate to dimensional accuracy, fit, and material integrity as per design specifications).
Intended Use:	The device performs its intended use of treating tooth malocclusion in patients with permanent dentition by positioning teeth via continuous gentle force. This is affirmed through a substantial equivalence determination to predicates with established safe and effective use. The software system, Ortho Analyzer, is used for management of 3D scanned orthodontic models, orthodontic diagnosis by measuring/analyzing/inspecting/visualizing 3D scanned models, virtual planning of orthodontic treatments by simulating tooth movements, and design of orthodontic appliances. The prescribing physician reviews and approves the model scheme before production.
Safety:	A Risk Analysis was performed according to ISO 14971:2012, assessing the modification (material change) and its impact on performance and safety.

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

This information is not applicable as the device is a physical orthodontic aligner, and its 510(k) submission primarily relies on substantial equivalence and engineering/biological verification and validation, not a clinical study involving a "test set" of patient data for AI performance evaluation. The "software" mentioned (Ortho Analyzer) is a tool for design and planning, not a diagnostic AI.

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)

This information is not applicable for the reasons stated above.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable for the reasons stated above.

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

This information is not applicable. While there is software involved in the design and planning of the aligners (Ortho Analyzer), it is not described as a standalone diagnostic AI algorithm. The process explicitly involves a "dental health professional (dentist/orthodontist)" who "determines a course of treatment" and a "prescribing physician reviews and approves the model scheme." This indicates a human-in-the-loop design and prescription process.

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

This information is not applicable in the context of diagnostic AI performance. For the aligners, the "ground truth" would relate to successful orthodontic treatment outcomes, which are assessed clinically by the treating dentist/orthodontist over time, not through a single reference standard for an AI algorithm.

8. The sample size for the training set

This information is not applicable. The device itself is a physical product. While the "Ortho Analyzer" software likely has an underlying model or algorithm for generating treatment plans, the document does not provide details of its training set, as this is not an AI diagnostic submission.

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

This information is not applicable for the reasons stated above.

Summary

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February 10, 2020

Argen Corporation % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 7949 Beaumont Green East Drive Indianapolis, Indiana 46250

Re: K192846

Trade/Device Name: Argen Clear Aligner, Argen Clear Aligner Premium Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 10, 2020 Received: January 13, 2020

Dear Patsy Trisler:

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 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) K192846

Device Name

Argen Clear Aligner and Argen Clear Aligner Premium

Indications for Use (Describe)

The Argen Clear Aligner and Arger Premium are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The aligner positions teeth by way of continuous gentle force.

Type of Use (Select one or both, as applicable)
× Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5

510(k) SUMMARY

I. SUBMITTER
Submitter Name:	Argen Corporation
Submitter Address:	5855 Oberlin DriveSan Diego, CA 92121
Contact Person:	Mr. Paul CasconeSenior Vice President, Research and Development
Telephone #:	858-455-7900
Date Prepared:	January 17, 2020
II. DEVICE
Device Trade Name:	Argen Clear Aligner and Argen Clear Aligner Premium
Common Name:	Aligner, Sequential
Classification NameNumberProduct CodeRegulatory Class	Orthodontic Plastic Bracket21 CFR 872.5470NXC2
Review Panel	Dental
III. PREDICATE DEVICE	Primary Predicate:K183229, Argen Clear Aligner, Argen CorporationReference Devices:K113618, ClearCorrect LLC, ClearCorrect SystemK182826, Ormco Spark Aligner System, Sybron DentalSpecialtiesK180941 Ortho System™, 3Shape A/S
IV. DEVICEDESCRIPTION andSUMMARY OFTECHNOLOGICALCHARACTERISTICS	The Argen clear aligners are comprised of series of clearplastic removable aligner trays that are designed to correcttooth malocclusions without the use of conventional wireand bracket orthodontic technology.A dental health professional (e.g. orthodontist or dentist)prescribes the Argen Clear Aligner or the Argen ClearAligner Premium based on an assessment of the patient'steeth. The dental health professional (dentist/orthodontist)takes intraoral scans or physical impressions of the patient'steeth, determines a course of treatment with the system, andcompletes a prescription form using a standard dentalsoftware used for tooth alignment. The series of plastictrays are designed in accordance with the physician'sprescription using standard dental software for planning thetooth alignment.The software system used is Ortho Analyzer, 2019 ver1.8.1.0 by 3Shape A/S (K180941). It is used for
	management of 3D scanned orthodontic models, orthodonticdiagnosis by measuring, analyzing, inspecting andvisualizing 3D scanned orthodontic models, virtual planningof orthodontic treatments by simulating tooth movements,and design of orthodontic appliances based on 3D scannedorthodontic models.
	The prescribing physician reviews and approves the modelscheme before the molds are produced. Once approved,Argen produces trays, which are formed of clear, thin,thermoformed plastic. The trays are provided to the dentalhealth care professional who provides them to the patient,confirming fit and design.
	The thermoplastic materials used in the manufacture of theArgen aligners are similar to the materials commonly used inmany dental and orthodontic appliances including clearaligners. The Argen Clear Aligner is made of athermoplastic polyurethane resin and the Argen ClearAligner Premium is made of a thermoplastic polyurethane-polyester composite resin.
V. INDICATIONS FORUSE	The Argen Clear Aligner and Argen Clear AlignerPremium are indicated for the treatment of toothmalocclusion in patients with permanent dentition (i.e. allsecond molars). The aligner positions teeth by way ofcontinuous gentle force.
VI. COMPARISON OFTECHNOLOGICALCHARACTERISTICSWITH THEPREDICATE ANDREFERENCEDEVICES	The Argen clear aligners have the same intended use as thepredicate and reference devices. There are no fundamentaltechnological differences between the Predicate and themodified device. The only modification(s) are as noted -different thermoplastic materials than used for the predicatealigner. Comparison Tables A (for the Argen Clear Aligner)and B (for the Argen Clear Aligner Premium) follow on thenext pages.
VII. SUMMARY OFPERFORMANCEDATA AND DESIGNCONTROLS	A Risk Analysis was performed according to ISO14971:2012 and documentation was included in the 510(k)to assess the modification and the impact on performanceand safety.
	Physical properties and Biocompatibility testing werereferenced in the Predicate device and the two Referencedevice submissions.
	Verification and validation activities were assessed on theproposed device to ensure consistency between the alignerseries' design and manufactured aligners. The results showthe proposed device met all pre-defined acceptance criteria.
VIX. SUBSTANTIALEQUIVALENCECONCLUSION	The information and data provided in this Special 510(k)establish that the modified device is substantially equivalentin the intended use, design, principle of operation,technology, and materials to the predicate.

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Table A – Substantial Equivalence Comparison [For proposed Argen Clear Aligner]

	Predicate DeviceK183229	Proposed DeviceK192846	Reference DeviceK113618
Device Name	Argen Clear Aligner	Argen Clear Aligner	Clear Correct System
Manufacturer	Argen Corporation	Argen Corporation	Clear Correct, LLC
ClassificationNameProduct CodeClass	21 CFR 872.5470Orthodontic PlasticBracketNXC2	Same	Same
Indications forUse	The Argen Clear Aligneris indicated for thetreatment of toothmalocclusion in patientswith permanent dentition(i.e. all second molars).The aligner positionsteeth by way ofcontinuous gentle force.	Same	Same
Mode of Action	The appliance appliesgentle forces on teethaccording to the planprescribed by the doctor.	Same	Same
Description ofUse	Each removablepreformed plastic tray isworn by the patient asprescribed by the doctor,usually a few weeksprior to using the nextsequential aligner tray.	Same	Same
Material	Thermoplasticpolyurethane resin	Same	Same
Software Usedfor TreatmentPlanning/Manufacture	Yes	Same software	Yes
Prescription Use	Rx	Same	Same
Biocompatibility	Yes, shown to meetrequirements	Same	Same
Verification andValidationTesting	Yes, performed	Yes, performed	Presumed performed

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Table B – Substantial Equivalence Comparison [For proposed Argen Clear Aligner Premium]

	Predicate DeviceK183229	Proposed DeviceK192846	Reference DeviceK182826
Device Name	Argen Clear Aligner	Argen Clear AlignerPremium	Ormco™ Spark™ Aligner System
Manufacturer	Argen Corporation	Argen Corporation	Sybron DentalSpecialties
ClassificationName	21 CFR 872.5470Orthodontic PlasticBracket	Same	Same
Product CodeClass	NXC2	Same	Same
Indications forUse	The Argen Clear Aligneris indicated for thetreatment of toothmalocclusion in patientswith permanent dentition(i.e. all second molars).The aligner positionsteeth by way ofcontinuous gentle force.	Same	Same
Mode of Action	The appliance appliesgentle forces on teethaccording to the planprescribed by thedoctor.	Same	Same
Description ofUse	Each removablepreformed plastic tray isworn by the patient asprescribed by thedoctor, usually a fewweeks prior to using thenext sequential alignertray.	Same	Same
Material	Thermoplasticpolyurethane polyestercomposite resin	Same	Same
Software Usedfor TreatmentPlanning/Manufacture	Yes	Same software	Yes
Prescription Use	Rx	Same	Same
Biocompatibility	Yes, shown to meetrequirements	Same	Same
Verification andValidationTesting	Yes, performed	Yes, performed	Presumed performed

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.