The Argen Clear Aligner is 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 Aligner is comprised of a 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 based on an assessment 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 material used in the manufacture of the Argen aligners is similar to the material commonly used in many dental and orthodontic appliances including clear aligners.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Argen Clear Aligner. It primarily demonstrates substantial equivalence to a predicate device, rather than presenting a standalone study with specific acceptance criteria and performance metrics for the Argen Clear Aligner itself. As such, no specific acceptance criteria or a dedicated study proving the device meets those criteria are directly provided for the Argen Clear Aligner's efficacy in tooth alignment.

Instead, the submission relies on the established safety and efficacy of its predicate device and the similarity of its design and materials.

Here's an analysis of what is and isn't available based on your request:

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

Acceptance Criteria for the Argen Clear Aligner: Not explicitly stated as performance metrics for tooth alignment. The submission focuses on demonstrating substantial equivalence to a predicate device (The Align System, K981095). Therefore, the "acceptance criteria" are implicitly that the Argen Clear Aligner is as safe and effective as the predicate.
Reported Device Performance of Argen Clear Aligner: No specific performance metrics (e.g., accuracy of tooth movement, treatment success rates) are reported for the Argen Clear Aligner. The document states that "Animal and human performance testing are not required for this product type," indicating clinical efficacy trials were not performed for this 510(k) submission.

The comparison table (Page 5) highlights similarities between the Argen Clear Aligner and the predicate device, which serves as the basis for substantial equivalence:

Feature/Criterion	Argen Clear Aligner	The Align System (Predicate)	Result/Similarity
Intended Use	Similar	Similar	Met
Mode of Action	Similar	Similar	Met
Method of Use	Similar	Similar	Met
Polymer Materials	Similar	Similar	Met
Mechanical Testing	Referenced Dentsply: K062828	Referenced Dentsply: K062828	Assumed Met
Biocompatibility	Yes	Yes	Met
OTC or Rx	Rx	Rx	Met
Software Use	Yes	Yes	Met
Sterile	No	No	Met

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

Sample Size: Not applicable. No dedicated performance study with a test set was conducted for the Argen Clear Aligner for its 510(k) submission. The submission relies on non-clinical performance and biocompatibility testing referencing another device (Dentsply's K062828), which is not detailed here.
Data Provenance: Not applicable for a performance study of the Argen Clear Aligner. The data presented is for the predicate device comparison and general device description.

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

Not applicable. No ground truth establishment by experts for a test set is described for the Argen Clear Aligner's 510(k) submission.

4. Adjudication method for the test set

Not applicable. As no test set performance study was conducted, no adjudication method is mentioned.

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. This device is a physical medical device (clear aligners), not an AI-assisted diagnostic or therapeutic tool. Therefore, a multi-reader multi-case comparative effectiveness study with AI assistance is not relevant or described.

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

No. This device is a physical medical device. While software is used in its design (Ortho Analyzer by 3Shape A/S), the submission does not detail a standalone algorithm performance study for tooth movement prediction or clear aligner design, as this is typically handled by the software manufacturer's own submissions. The Argen Clear Aligner is the manufactured product based on the software's output.

7. The type of ground truth used

Not applicable for a performance study of the Argen Clear Aligner. The "ground truth" implicitly referenced across the entire 510(k) process for substantial equivalence is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that would require a training set in the context of its 510(k) submission. The "designs" of the aligners are based on physician prescriptions and standard dental software, not a learned model from a training set in the way AI algorithms are trained.

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

Not applicable. See point 8.

In summary, the provided document is a 510(k) premarket notification primarily demonstrating substantial equivalence due to physical and functional similarities to an existing predicate device. It does not contain a study of the Argen Clear Aligner's clinical performance against specific acceptance criteria, nor does it detail AI algorithm performance metrics.

Summary

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June 7, 2019

Argen Corporation Mr. Paul Cascone Senior Vice President, Research and Development % Patsy Trisler Regulatory Consultant Qserve Group US, Inc. 5600 Wisconsin Avenue, #509 Chevy Chase, Maryland 20815

Re: K183229

Trade/Device Name: Argen Clear Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 6, 2019 Received: May 8, 2019

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.

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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 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.

Srinivas Nandkumar, Ph.D. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K183229

Device Name

Argen Clear Aligner

Indications for Use (Describe)

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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510(k) Summary K183229

Submitter Name:	Argen Corporation
Submitter Address:	5855 Oberlin DriveSan Diego, CA 92121
Phone Number:	858-455-7900
Contact Person:	Mr. Paul CasconeSenior Vice President, Research and Development
Date Prepared:	June 5, 2019
Device TradeName:	Argen Clear Aligner
Common Name	Aligner, Sequential
Classification NameNumberProduct CodeRegulatory Class	Orthodontic Plastic Bracket21 CFR 872.5470NXC2
Primary PredicateDevice:	K981095; The Align System; Align Technology, Inc.
Reference Devices:	K180941; Ortho System™; 3Shape A/SK062828; Mouthguard and Aligner Materials, Dentsply International
Indications for UseStatement	The Argen Clear Aligner is indicated for the treatment of toothmalocclusion in patients with permanent dentition (i.e. all secondmolars). The aligner positions teeth by way of continuous gentleforce.
Device Descriptionand Summary ofTechnologicalCharacteristics	The Argen Clear Aligner is comprised of a series of clear plasticremovable aligner trays that are designed to correct toothmalocclusions without the use of conventional wire and bracketorthodontic technology.
	A dental health professional (e.g. orthodontist or dentist) prescribesthe Argen Clear Aligner based on an assessment of the patient'steeth, determines a course of treatment with the system, andcompletes a prescription form using a standard dental softwareused for tooth alignment. The series of plastic trays are designed inaccordance with the physician's prescription using standard dentalsoftware for planning the tooth alignment.
	The software system used is Ortho Analyzer, 2019 ver 1.8.1.0 by3Shape A/S (K180941). It is used for management of 3D scannedorthodontic models, orthodontic diagnosis by measuring, analyzing,inspecting and visualizing 3D scanned orthodontic models, virtualplanning of orthodontic treatments by simulating tooth movements,and design of orthodontic appliances based on 3D scannedorthodontic models.

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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 material used in the manufacture of the Argen aligners is similar to the material commonly used in many dental and orthodontic appliances including clear aligners.

Mechanism of The mechanism of action is similar to the predicate device. Action Orthodontic tooth movement, achieved over time with the clear aligner systems, occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on the dental professional's prescription. The trays are held in place by pressure and can be removed by the patient at any time.

Device Testing Non-Clinical Performance Testing: Reference Dentsply's K062828.

Biocompatibility Testing: Reference Dentsply's K062828.

Animal | Human Testing

Animal and human performance testing are not required for this product type.

Comparison to A comparison of the Argen Clear Aligner to the predicate device Predicate Device: shows the following (See Substantial Equivalence Comparison Table on last page of this Summary):

I The indications for use is similar.
. The mechanism of action is similar.
. The polyurethane used to make the aligners is similar to the predicate device, a single-layer thermoformable material:
. Dental software is used in the design and manufacture of both Argen Clear Aligner and the predicate.
. The method of manufacture and customizing the aligners is similar.

Substantial There are no notable differences between the Argen Clear Aligner Equivalence and the predicate. Therefore it can be concluded that the Argen Clear Aligner is substantially equivalent to the Align Technology Conclusion predicate device.

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Trade Name:	Argen Clear Aligner	The Align System
510(k) Number	K183229	K981095
Manufacturer	Argen Corporation	Align Technology, Inc.
Classification # &Product CodeClass	21 CFR 852.5470NXC2	21 CFR 852.5470NXC2
Intended Use	The Argen Clear Aligner isindicated for the treatment oftooth malocclusion in patientswith permanent dentition (i.e. allsecond molars). The alignerpositions teeth by way ofcontinuous gentle force.	The Align System is indicatedfor the treatment of toothmalocclusion in patients withpermanent dentition (i.e. allsecond molars). The AlignSystem positions teeth by wayof continuous gentle force.
Mode of Action	Alignment of teeth byapplication of continuous gentleforce, by sequential use ofpreformed plastic trays.	Alignment of teeth byapplication of continuous gentleforce, by sequential use ofpreformed plastic trays.
Method of Use	Each preformed plastic tray isworn by the patient asprescribed by the dentalpractitioner, usually a fewweeks prior to using the nextsequential aligner tray.	Each preformed plastic tray isworn by the patient asprescribed by the dentalpractitioner, usually a fewweeks prior to using the nextsequential aligner tray.
PolymerMaterial(s)	Thermoformable polymer singlelayer	Thermoformable polymer singlelayer
MechanicalPerformanceTesting:	Reference: Dentsply: K062828	Reference: Dentsply: K062828
BiocompatibilityTesting	Yes	Yes
OTC or Rx	Rx	Rx
Software Use	Yes	Yes
Sterile	No	No

Substantial Equivalence Comparison

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.