The Laon Ortho is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment.

The use of the Laon Ortho requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Description

Laon Ortho is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for Laon Ortho primarily focus on demonstrating substantial equivalence to predicate devices, particularly concerning its design, functionality, and intended use. While it mentions "verification and validation (V&V) testing" and "performance test," it does not provide granular details about the specific acceptance criteria for AI performance, the study design, sample sizes, ground truth establishment methods, or expert qualifications that would typically be associated with rigorous clinical or non-clinical performance studies for AI/ML devices.

The key takeaway is that the clearance appears to be based on the equivalence of the "Automatic Simulation Mode" to the "Manual Mode" in achieving the same treatment planning, rather than a standalone AI performance study against a clinical ground truth.

Therefore, I will extract what is available and highlight what is not present given the prompt's request.

Here's the breakdown based on the provided document:

Acceptance Criteria and Device Performance for Laon Ortho

The document states: "The results of the verification and validation (V&V) testing showed that the Automatic Mode achieves the same treatment planning as the existing workflow." This implies the "acceptance criteria" for the Automatic Simulation Mode (the new feature) was equivalence to the existing manual workflow for treatment planning. However, the specific metrics for "same treatment planning" are not detailed.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Automatic Mode achieves the "same treatment planning" as existing workflow.	"The results of the verification and validation (V&V) testing showed that the Automatic Mode achieves the same treatment planning as the existing workflow."
Meets all performance test criteria.	"Through the performance test, it was confirmed that Laon Ortho meets all performance test criteria and that all functions work without errors."

Note: The document does not specify quantitative metrics (e.g., accuracy, precision, F1-score, or specific measurement deviations) for "same treatment planning" or "meets all performance test criteria."

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: Not explicitly stated. The document mentions "verification and validation (V&V) testing" and "performance test" but does not provide the number of cases or scans used for these tests.
Data Provenance: Not explicitly stated. The company is based in South Korea, but the origin (e.g., country, specific clinics) of the data used for V&V testing is not mentioned. It also doesn't explicitly state if the data was retrospective or prospective, though performance testing often uses existing (retrospective) data.

3. Number of Experts and Their Qualifications for Ground Truth

Number of Experts: Not explicitly stated. The document states, "The use of the Laon Ortho requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software." This refers to the user of the software, not the experts who established the ground truth for V&V.
Qualifications of Experts: Not explicitly stated. It's highly probable that orthodontic experts were involved in evaluating if the Automatic Mode achieved "the same treatment planning," but their specific number, roles, and qualifications (e.g., years of experience, board certification) are not detailed in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly stated. Given the lack of detail on the "same treatment planning" assessment, the method for resolving discrepancies among evaluators (if multiple were used) is unknown from this document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, not explicitly stated or implied. The summary explicitly notes "Clinical Test Summary: Not Applicable." This indicates that a rigorous human-in-the-loop study, such as an MRMC study comparing human readers with and without AI assistance, was not performed or submitted as part of this 510(k). The focus was on the internal equivalence of the AI-driven "Automatic Mode" to the device's own "Manual Mode."
Effect Size: N/A, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance Study

Was a standalone study done? Yes, in an indirect sense, but against an internal benchmark. The "Automatic Simulation Mode" is an algorithm that performs treatment planning. The V&V testing confirmed that this algorithm's output ("Automatic Mode") aligns with the output of the "existing workflow" (presumably the manual or previously cleared aspects of the device). However, this is not a standalone study against an independent, external clinical ground truth (e.g., pathology, clinical outcomes). It's more of a functional validation against an established internal process. The document does not provide standalone quantitative performance metrics (e.g., sensitivity, specificity, accuracy) for the algorithm itself.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" used for evaluating the "Automatic Simulation Mode" was its ability to achieve "the same treatment planning as the existing workflow." This implies that the accepted output or method of the "existing workflow" served as the reference. It is an internal ground truth based on the device's established manual capabilities, rather than an independent clinical ground truth like pathology, surgical findings, or long-term patient outcomes.

8. Sample Size for the Training Set

Training Set Sample Size: Not stated. The document refers to "Software Validation" and "Performance Testing" but provides no information about the size or characteristics of the data used to train the "Automatic Simulation Mode" algorithm.

9. How the Ground Truth for the Training Set Was Established

Ground Truth Establishment for Training: Not stated. Since the training set details are omitted, the method for establishing its ground truth is also not provided.

Summary

FDA 510(k) Clearance Letter - Laon Ortho

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.07.05

April 23, 2025

LAON MEDI Inc.
Mina Yun
Quality Management Representative (QMR)
60 Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840
C-504
Gwacheon-si, Gyeonggi-do 13840
SOUTH KOREA

Re: K250198
Trade/Device Name: Laon Ortho
Regulation Number: 21 CFR 872.5470
Regulation Name: Orthodontic Plastic Bracket
Regulatory Class: Class II
Product Code: PNN, LLZ
Dated: January 23, 2025
Received: January 23, 2025

Dear Mina Yun:

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 (the 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.

Page 2

K250198 - Mina Yun Page 2

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K250198 - Mina Yun Page 3

assistance/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,

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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K250198

Device Name: Laon Ortho

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)

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."

Page 5

C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/

Page 1 / 6

510(k) Summary

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR 807.92(a)(a)]

Jan 23, 2025

2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]

Name of Manufacturer: LAON MEDI Inc.
Address: C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea / Tel: +82 2 507 8990
Contact Name: Mina Yun
Telephone No.: +82 2 507 8993
Fax No.: +82 2 507 8997
Email Address: may@laon-medi.com

3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]

Trade name: Laon Ortho

Classification Description	21 CFR Section	Product Code
Orthodontic Software	872.5470	PNN
System, Image Processing, Radiological	892.2050	LLZ

As stated in 21 CFR, parts 872.5470 and 892.2050, this generic types of devices has been classified as Class II.

Page 6

C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/

Page 2 / 6

4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]

The identified predicate devices within this submission are shown as follow:

Predicate device #1

510(k) Number: K232564
Applicant: LAON MEDI Inc.
Classification Name: Orthodontic Software
Trade Name: Align Studio

Predicate device #2

510(k) Number: K180941
Applicant: 3Shape A/S
Classification Name: Orthodontic Software
Trade Name: Ortho System

5. Description of the Device [21 CFR 807.92(a)(4)]

6. Indications for Use [21 CFR 807.92(a)(5)]

Page 7

C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/

Page 3 / 6

7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]

There are no significant differences between Laon Ortho and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics.

	Proposed Device	Predicate Device #1	Predicate Device #2	SE Decision
K Number	-	K232564	K180941	-
Manufacturer	LAON MEDI Inc.	LAON MEDI Inc.	3Shape A/S	-
Model	Laon Ortho	Align Studio	Ortho System	-
Intended Use	The Laon Ortho is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Laon Ortho requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.	The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Align Studio requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.	Ortho System™ for dental retainers and dental cast for sequential aligners is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.	Same as predicate devices
Module	Imports scanned image of patient	Imports scanned image of patient	Imports scanned image of patient	Same as predicate devices
	Stand-alone software module	Stand-alone software module	Stand-alone software module
	Can be used to design dental casts	Can be used to design dental casts	Can be used to design dental casts
	Useful for diagnosis, treatment planning, and CAD design	Useful for diagnosis, treatment planning, and CAD design	Useful for diagnosis, treatment planning, and CAD design

Page 8

C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/

Page 4 / 6

	Proposed Device	Predicate Device #1	Predicate Device #2	SE Decision
	Virtual planning of tooth movement	Virtual planning of tooth movement	Virtual planning of tooth movement
	Supports .stl files	Supports .stl files	Supports .stl files
Managing patient and case base data	Creating, editing, deleting and copying patient data	Creating, editing, deleting and copying patient data	Creating, editing, deleting and copying patient data	Same as predicate devices
	Creating, editing, deleting and copying case data	Creating, editing, deleting and copying case data	Creating, editing, deleting and copying case data
Collection of study material	Surface scan from STL file	Surface scan from STL file	Surface scan from STL file	Same as predicate device #2
	CT image data(DICOM)	CT image data(DICOM)	CT image data(DICOM)
	2D overlay(PNG, JPG, BMP)	-	2D overlay(PNG, JPG, BMP)
	Creation of virtual 3D virtual dental models	Creation of virtual 3D virtual dental models	Creation of virtual 3D virtual dental models
Alignment of study material	Aligning surface scan or CT image	Aligning surface scan or CT image	Aligning surface scan or CT image	Same as predicate device #2
	Aligning cephalometric images	Aligning cephalometric images	Aligning cephalometric images
	Alignment of 2D overlays	-	Alignment of 2D overlays
	Ability to check/adjust DICOM visibility	Ability to check/adjust DICOM visibility	Ability to check/adjust DICOM visibility
Analyzing study material	Definition of dental Arch shape & length	Definition of dental Arch shape & length	Definition of dental Arch shape & length	Same as predicate device #1
	-	-	Wire length
	Tooth width measurements	Tooth width measurements	Tooth width measurements
	Tooth and gingiva separation/segmentation	Tooth and gingiva separation/segmentation	-
	Bolton's analysis	Bolton's analysis	Bolton's analysis
	Space analysis	Space analysis	Space analysis
	Overjet/overbite	Overjet/overbite	Overjet/overbite

Page 9

C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/

Page 5 / 6

	Proposed Device	Predicate Device #1	Predicate Device #2	SE Decision
	Occlusal mapping	Occlusal mapping	Occlusal mapping
Treatment simulation	-	-	2D simulation	Same as predicate device #1
	3D simulation	3D simulation	3D simulation
Treatment Planning Workflow	Manual Mode	Manual Mode	Manual Mode	Similar
	Automatic Simulation Mode	-	-

Similar

The device proposed for 510(k) is Laon Ortho, a modification of the predicate device Align Studio (K232564, cleared on March 12, 2024). The proposed device includes the addition of an Automatic Simulation Mode. However, this change doesn't alter the existing workflow. The results of the verification and validation (V&V) testing showed that the Automatic Mode achieves the same treatment planning as the existing workflow. Therefore, this change does not affect substantially equivalence on safety and effectiveness.

Page 10

C-504, 60, Gwacheon-daero 7na-gil, Gwacheon-si, Gyeonggi-do, 13840, Republic of Korea
+82 2 507 8990 | qna@laon-medi.com | https://laonmedi.io/

Page 6 / 6

Non-Clinical Test Summary [21 CFR 807.92(b)(1)]

1) Software Validation

Laon Ortho contains Basic Documentation Level software. Software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: Content of premarket submissions for Device Software Functions, on November 04, 2021.

2) Performance Testing

Through the performance test, it was confirmed that Laon Ortho meets all performance test criteria and that all functions work without errors. Test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device.

Clinical Test Summary [21 CFR 807.92(b)(2)]

Not Applicable

Conclusion [21 CFR 807.92(b)(3)]

Based on a comparison of intended use, indications, principle of operations, features and technical data, and the test results, the Laon Ortho is found to be as safe and as effective as the predicate device. Intended use and performance is found to be substantially equivalent to the predicate device, Align Studio (K232564) from LAON MEDI Inc. and Ortho System (K180941) from 3Shape A/S.

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.