Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's specific prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth.

The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be worn for at least 2 weeks. Patients the total treatment time lasts about 6 to 24 months.

AI/ML Overview

The provided text is a 510(k) summary for the Serafin® orthodontic clear aligner system. It focuses on demonstrating substantial equivalence to a predicate device (Invisalign) through non-clinical testing. Crucially, this document does not contain information about clinical studies with human subjects, algorithm performance metrics (such as accuracy, sensitivity, or specificity), or the use of AI/machine learning.

Therefore, I cannot provide details on the following aspects of your request:

A table of acceptance criteria and reported device performance related to AI/algorithm output (as no such data is present).
Sample size used for a test set for AI/algorithm performance.
Number of experts used to establish ground truth for a test set.
Adjudication method for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study.
Standalone (algorithm only) performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/algorithm performance.
Sample size for the training set for an AI/algorithm.
How the ground truth for the training set was established for an AI/algorithm.

The document focuses on the physical, chemical, and biological properties of the device itself (the clear aligner), not on computational performance or diagnostic capabilities associated with AI.

Here's what the document does provide regarding acceptance criteria and testing, albeit for the physical device, not an AI algorithm:

1. Acceptance Criteria and Device Performance (for the physical device):

Acceptance Criteria (Set Test Criteria)	Reported Device Performance
Physical and Chemical Tests:	All test results met the preset test criteria, except as noted for Flexural Modulus.
Appearance	Conformed to standard
Dimension	Conformed to standard
Water sorption & solubility	Low water uptake, Low water solubility (conformed to standard)
3-point flexural strength (Flexural Modulus, Flexural Strength, Tear Strength)	Flexural Modulus did not meet standard requirement of 1500 MPa. The document states this requirement is not applicable as the device is designed for subtle force, not rigidity. Flexural Strength and Tear Strength conformed to standard.
Hardness	Conformed to standard
pH	Conformed to standard
Potassium permanganate reducing substances residue	Conformed to standard
Residue on evaporation	Conformed to standard
Heavy metals	Conformed to standard
Ultraviolet-visible spectrum	Conformed to standard
Biological Evaluation:	Testing demonstrated biocompatibility.
Cytotoxicity	Conformed to standard
Skin sensitization	Conformed to standard
Acute oral mucosa irritation	Conformed to standard
Intracutaneous reactivity	Conformed to standard
Acute systemic toxicity	Conformed to standard
Irritation	Conformed to standard
Biological risk assessment (ISO 10993-1, ISO 7405)	Conducted
Toxicological risk assessment (for leachables/degradation products)	Conducted to monitor and mitigate biological risk.

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

No information on a "test set" for an AI algorithm.
The non-clinical testing was performed on "test articles" (implied to be samples of the Serafin® aligner material/device). The exact number of samples is not stated.
Data Provenance: The testing was done by the manufacturer (TNS Co., Ltd., based in South Korea) or their designated testing facilities. It's non-clinical lab testing of material properties.

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

Not applicable as the testing is for physical/chemical/biological properties of the device material, not for an AI algorithm requiring expert-established ground truth. Standards (e.g., ISO, MFDS, ADA ANSI) define the test procedures and acceptance criteria.

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

Not applicable. This concept applies to human reader studies or AI validation with human adjudicated ground truth, which is not 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:

No, an MRMC study was not done, as this submission is for a physical medical device (orthodontic aligner), not an AI-powered diagnostic or assistive tool.

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

Not applicable, as there is no AI algorithm being evaluated in this submission. The "3D software" mentioned is for generating a 3D model of teeth and treatment plan, which is then reviewed by a dental practitioner, not for AI-driven diagnosis or analysis.

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

For the physical device testing, the "ground truth" or reference was established by international and national standards (ISO 20795-2, ISO 10993 series, MFDS guidelines, ADA ANSI 41-2020) for material properties (e.g., flexural strength, water sorption) and biocompatibility (e.g., cytotoxicity).

8. The sample size for the training set:

Not applicable, as there is no AI algorithm with a distinct "training set" described in this document.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 22, 2024

TNS Co., Ltd. Won-Gun Chang CEO 908, 46, Digital-ro 9gil Geumcheon-gu. Seoul 08512 SOUTH KOREA

Re: K232074

Trade/Device Name: Serafin® Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 23, 2023 Received: November 24, 2023

Dear Won-Gun Chang:

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 (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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K232074

Device Name Serafin®

Indications for Use (Describe) The Serafin is intended for the orthodontic treatment of malocclusion

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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect

of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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006_ 510(k) SUMMARY

Date: February 21, 2024

1. SUBMITTER

TNS Co., Ltd. 908, 46, Digital-ro 9gil, Geumcheon-gu, Seoul, Republic of Korea TEL : +82-2-785-2804 FAX : +82-2-785-2803 Contact Name: Won-gun Chang Email: tns0109@tnsmile.kr

2. DEVICE

Serafin® ·Trade Name: ·Common Name: Clear Aligner System · Regulation Number 872.5470 ·Class: 2 ·Classification Product Code: NXC ·Classification Name: Orthodontic plastic bracket

3. PREDICATE DEVICE

Serafin®

: K220287 (Primary predicate) Invisalign, Invisalign, Align Technology Inc.

4. DEVICE DESCRIPTION

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5. INDICATIONS FOR USE

Serafin®

The Serafin is intended for the orthodontic treatment of malocclusion.

6. NON-CLINICAL TESTING

The following test articles were tested based on the referenced standard. All the test results met the preset test criteria.

Physical and chemical test

Guideline on Review and Approval for appliance, Orthodontic, Resin (Sheet Type)(2018.12.) (MFDS)
Appearance, Dimension, Water sorption & solubility, 3-point flexural strength, hardness
Appearance, pH, Potassium permanganate reducing substances residue, Residue on evaporation, Heavy metals, Ultraviolet-visible spectrum
ISO 20795-2 Dentistry Base polymers Part 2: Orthodontic base polymers

2) Biological evaluation

ISO 10993-1 Biological evaluation of medical devices Part 1: Evaluation . and testing within a risk management process
. ISO 7405 – Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
. ISO 10993-17 - Biological evaluation of medical devices - Part 17: Establishment of allowable limits for leachable substances
ISO 10993-18 – Biological evaluation of medical devices - Part 18: Chemical characterization
. ISO 10993-5 - Biological evaluation of medical devices - Part 5: Cytotoxicity
. ISO 10993-10 - Biological evaluation of medical devices - Part 10: Skin sensitization, Acute oral mucosa irritation, Intracutaneous reactivity
ISO 10993-11 - Biological evaluation of medical devices - Part 11: Acute systemic toxicity
ISO 10993-23 Biological evaluation of medical devices Part 23: Tests for

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irritation

ADA ANSI 41-2020 Evaluation of Biocompatibility of Medical Devices Used • in Dentistry

7. SUBSTANITAL EQUIVALENCE

	Subject device	Predicate Device	Discuss/Justify theDifferences
510(k) Number	K232074	K220287	-
Trade Name	Serafin®	Invisalign	-
Manufacturer	TNS Co., Ltd.	Align Technology Inc.	-
Common Name	Clear Aligner System	Aligner, Sequential	Same
Device Class	2	2	Same
Product Code	NXC	NXC	Same
Device Description	Serafin® is composed of series of transparent removable orthodontic appliances manufactured using thermoforming technology based on a 3D model of the patient's teeth, customized according to a Dental Practitioner's prescription, indicated for treatment of dental malocclusion by applying continuous gentle force to realign teeth. The time for each stage of aligner usage is set in the personal treatment plan, and this varies for each patient and the Dental Practitioner's choice. Each set of aligners needs to be	Invisalign is series of transparent removable orthodontic appliance, indicated for treatment of dental malocclusion. Invisalign consists of an upper and lower parts in variable sizes and lengths customized for a specific patient. It is produced by using 3D printer based on 3D scanned image file sent by a Dental Practitioner. The aligners and attachment templates are made of thermoplastic polymer, with/without PFA system made of photopolymerizable methacrylate based resin.	Equivalent

	worn for at least 2 weeks.Patients the total treatment timelasts about 6 to 24 months.
Indications for use	The Serafin is intended for theorthodontic treatment ofmalocclusion.	The Invisalign System isintended for the orthodontictreatment of malocclusion.	Same
Clinical condition	Overbite, underbite, crossbite,gap teeth, open bite, crowdedteeth, baby and permanentteeth.Limitations include severecases where large movement ofa tooth is necessary such as atooth rotated over 20 degrees,large gap between teeth, teethwhich require intrusion orextrusion	Overbite, underbite, crossbite,gap teeth, open bite, crowdedteeth, baby and permanentteeth.Limitations include severecases where large movement ofa tooth is necessary such as atooth rotated over 20 degrees,large gap between teeth, teethwhich require intrusion orextrusion	Same
Patient Population	Child and adolescent(whenfull permanent dentition ispresent), Adults	Children, Adolescents andAdults	Same
Use Location	Dental intraoral Devices	Dental intraoral Devices	Same
OTC orPrescription (Rx)Device	Rx only	Rx only	Same
Design
Principle ofOperation	Serafin® is series of transparentremovable orthodonticappliances, indicated fortreatment of dentalmalocclusion. It is produced byusing 3D printer based on 3Dscanned image file sent by aDental Practitioner along with aprescription of a specificpatient. Series of clear plasticappliances (Aligners) moves	The Invisalign System consistsof a series of doctor-prescribed,thin, clear plastic removableorthodontic appliances(aligners) and proprietary 3-Dsoftware. The aligners gentlymove thepatient's teeth in smallincrements from their originalstate to a more optimal, treatedstate.	Equivalent

Appearance	the patients' teeth in smallincrements from their originalstate to a final, treated state byapplying continuous gentleforce to teeth while the patientis wearing it.	Image: Upper and lower parts	Equivalent
		Image: Orthodontic aligners
3D Software	3D Software: Produces 3Dmodel file of the the digitalscan.Create a treatment plan which isreviewed by dental practitionerto reject or requestmodifications.Approved treatment plan modelis 3D printed.	3D Software: Produces 3Dmodel file of the PVSimpression or the digital scan.Create a treatment plan which isreviewed by dental practitionerto reject or requestmodifications.Approved treatment plan modelis 3D printed.	Equivalent
Materials	Thermoplastic polymer :Zendura FLX :ThermoplasticUrethane,Copolyester	Thermoplastic polymerSmartTrack™	Equivalent
	(3-layer structure)	(Multilayer structure)
Physical State	Transparent removableorthodontic appliances consistof an upper and lower parts	Transparent removableorthodontic appliances consistof an upper and lower parts	Same
Material property	Zendura FLX Demonstratessufficient Ultimate FlexuralStrength, Water Sorption,Water Solubility as per ISO20795-2 : 2013	SmartTrack™ is materialengineered for use withInvisalign orthodontic	Equivalent

		treatment(Polyurethane)
		Intended to be used as dentalaligner
	Intended, marketed to be usedas dental aligner
Manufacturingprocess	Thermoforming on models,Trimming, Marking	Thermoforming on models,Trimming, Marking	Same
Biological
Tissue Contact	Surface device, permanent use(>30 days), Mucosal membrane	Surface device, permanent use(>30 days), Mucosal membrane	Same
Anatomical site	Intact teeth, gingival mucosa,interior vermilion (inner lip),and tongue	Intact teeth, gingival mucosa,interior vermilion (inner lip),and tongue	Same
Contact duration	at least 20 hrs or longer a day,up to 30 days	at least 20 hrs or longer a day,up to 30 days	Same
Biocompatiblility	Biological risk assessment,Toxicological risk assessmentas per ISO 10993-1, ISO 7405	Biocompatibility per the ISO10993 series standards	Equivalent

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8. SUBSTANTIAL EQUIVALENCE DISCUSSION

The subject devices share the same indications for use and the principle of operation as the predicate devices. They are intended for the same clinical conditions, patient populations, and use locations.

Predicate device includes an optional mandibular advancement feature (MAF), but subject device does not provide a MAF feature. The MAF option is a necessary function for 'Skeletal malocclusion', so it does not correspond to the indications for subject device.

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Both devices comprise a series of transparent, removable orthodontic appliances, used for at least 20 hours a day over a period of several weeks. The manufacturing process begins with a 3D image file of a patient's dentition, which serves as an input to each manufacturer's software. Each software identifies the individual teeth requiring treatment. The software then generates a 3D model of the patient's dentition, incrementally modifying it towards alignment. This 3D model is then printed out using a 3D printer. Subsequently, a thermoplastic polyurethane material is heated and moulded onto the 3D printed model, known as a thermoforming process. Any excess material is eliminated by trimming process. The resulting plastic appliances, both for Serafin® and Invisalign, are designed to apply a gentle, continuous force on the malocclusion site to realign the teeth.

Correspondingly, the principles of operation, intended use, manufacturing process, and 3D modeling process for Serafin® and Invisalign are identical. Both devices utilize a similar thermoforming polymer as a material, which demonstrates chemical, biological, and functional equivalence. The materials are thermoplastic polymers with a biocompatible polyurethane copolymer and are intended for use as clear aligner material.

However, since the materials are not exactly the same, further biological assessments and pre-clinical performance tests have been carried. For biocompatibility, Serafin® was tested as per ISO 10993-1 in Biological Risk Assessment. In addition, Toxicological Risk Assessment was conducted to monitor and mitigate the biological risk from unintended process residuals and degradation material under the light-curing process in 3D printing and the thermoforming process.

Regarding physical properties and clinical performance, Zendura FLX was tested according to "ISO 20795-2 Dentistry - Base polymers - Part 2: Orthodontic base polymers," under a 37°C wet environment. Since orthodontic base polymers are categorized as Type 3 (thermoplastic materials), testing was conducted for Flexural Modulus, Flexural Strength, Tear Strength, Water Sorption, and Water Solubility. The Flexural Modulus did not meet standard requirement of 1500 MPa. However, this requirement is relevant to highly rigid or inflexible materials, which does not reflect the

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current requirements for thermoplastic aligners. Considering that Serafin® and Invisalign are engineered to apply a subtle force for realignment, this standard does not apply, and the value primarily serves as an informative detail about the device's physical properties. The other results conformed to the standard, indicating good toughness, an effective ability to move teeth, low water uptake, and low water solubility.

Consequently, it can be concluded that the subject devices are substantially equivalent to the predicate devices in terms of similarity, risk acceptability, and efficacy.

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.