The use of the Align Studio requres 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

Align Studio 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 document, an FDA 510(k) summary for "Align Studio," does not contain detailed information about specific acceptance criteria, a comprehensive study proving the device meets those criteria, or the methodology (e.g., sample size, expert qualifications, ground truth establishment) typically associated with such studies for AI/ML-based medical devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices (Ortho System and CEREC Ortho Software) rather than presenting a detailed performance study against predefined acceptance criteria for an AI-powered system. The Non-Clinical Test Summary section briefly mentions "software validation" and "performance testing" but without quantifiable metrics or specific methodologies. It states that "Align Studio meets all performance test criteria and that all functions work without errors" and "test results support the conclusion that actual device performance satisfies the design intent and is equivalent to its predicate device."

Therefore, I cannot populate the table or answer most of the questions as the required information is not present in the provided text.

Here's what can be extracted based on the limited information provided:

1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with quantifiable performance metrics specific to an AI/ML system's output. It broadly states the device "meets all performance test criteria" and "functions work without errors." The focus is on functional equivalence to predicate devices rather than specific quantitative performance targets for an AI component.

2. Sample size used for the test set and the data provenance
Not specified. The document does not detail the test set used for performance evaluation, nor its size or origin (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The document doesn't describe the establishment of a ground truth for a test set, which would typically involve expert review for AI/ML performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not specified, as a detailed ground truth establishment process 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 MRMC comparative effectiveness study is mentioned. The submission focuses on substantial equivalence based on device features and intended use, not on human reader performance with AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Non-Clinical Test Summary" section mentions "Performance Testing" which could imply standalone testing, but no specific metrics for an algorithm-only performance (e.g., segmentation accuracy, measurement precision without human interaction) are provided. The device is described as "PC-based software" for "virtual orthodontics" that "automatically segments the crown and the gum," implying an algorithm performing actions. However, the document does not detail the standalone performance metrics for this automated segmentation or other AI features.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not specified. Given the lack of detailed performance study information, the type of ground truth used is not described.

8. The sample size for the training set
Not specified. The document does not provide details on the training set used for any AI/ML components within the "Align Studio" software.

9. How the ground truth for the training set was established
Not specified. Without information on a training set, the method of establishing its ground truth is also not provided.

Summary of available information regarding software validation and performance:

Software Validation: "Align Studio contains Basic Documentation Level software was designed and developed according to a software development process and was verified and validated."
Performance Testing: "Through the performance test, it was confirmed that Align Studio 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 Studies: "No clinical studies were considered necessary and performed."

This filing relies on demonstrating substantial equivalence to already cleared predicate devices based on shared technological characteristics and intended use, rather than presenting a novel performance study for an AI/ML component with specific acceptance criteria and detailed clinical validation results.

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.

March 12, 2024

Laon Medi Inc. Mina Yun Quality Management Representative 404, Bundang Techno Park B, 723, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13511 SOUTH KOREA

Re: K232564

Trade/Device Name: Align Studio Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: January 12, 2024 Received: January 12, 2024

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.

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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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Indications for Use

510(k) Number (if known) K232564

Device Name Align Studio

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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Image /page/4/Picture/0 description: The image shows the logo for LAON iMEDI. The text is in a sans-serif font, with the letters "LAON" and "MEDI" in green. The "i" in "iMEDI" is orange. The logo is simple and modern.

404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongna

+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com

K232564

510(k) Summary

[As required by 21 CFR 807.92]

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

August 24, 2023

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

Name of Manufacturer: LAON MEDI Inc.
Address: 404, Bundang Techno Park B, 723, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggido, 13511 Republic of Korea / Tel: 031-8017-7145
Contact Name: Mina Yun
Telephone No.: +82 10 3953 4808
Fax No.: +82 31 701 8863
may@laon-medi.com - Email Address:

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

Trade name: Align Studio

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.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in green, followed by "iMEDI" also in green, but with a small orange square above the "i". The logo is simple and modern, with a focus on the company name.

404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, C

+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com

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: K180941
. 3Shape A/S Applicant:
Classification Name: Orthodontic Software
Trade Name: Ortho System

Predicate device #2

510(k) Number: K171122
Applicant: Dentsply Sirona
Classification Name: ● Orthodontic Software
Trade Name: CEREC Ortho Software ●

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

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

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 (Export of Models, Indirect Bonding Transfer Media) based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives.

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.

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Image /page/6/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in large, green, sans-serif font. To the left of the "M" in "MEDI" is a small orange square. The rest of the text, "MEDI", is in the same green font as "LAON".

404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, Gyeonggi-do, 13511 Korea

+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com

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

There are no significant differences between Align Studio 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	SEDecision
K Number	-	K180941	K171122	-
Manufacturer	LAON MEDI Inc.	3Shape A/S	Dentsply Sirona	-
Model	Align Studio	Ortho System	CEREC Ortho Software	-
Intended Use	The Align Studio isintended for use as amedical front-end deviceproviding tools formanagement oforthodontic models,systematic inspection,detailed analysis,treatment simulation andvirtual appliance designoptions (Export ofModels, IndirectBonding Transfer Media)based on 3Dmodels ofthe patient's dentitionbefore the start of anorthodontic treatment. Itcan also be appliedduring the treatment toinspect and analyze theprogress of the treatment.It can be used at the endof the treatment toevaluate if the outcome isconsistent with theplanned/desiredtreatment objectives.The use of the AlignStudio requires the userto have the necessarytraining and domainknowledge in thepractice of orthodontics,as well as to havereceived a dedicatedtraining in the use of thesoftware.	Ortho System™ fordental retainers anddental cast for sequentialaligners is intended foruse as a medical front-end device providingtools for management oforthodontic models,systematic inspection,detailed analysis,treatment simulation andvirtual appliance designoptions based on 3Dmodels of the patient'sdentition before the startof an orthodontictreatment.The use of the OrthoSystem™ requires theuser to have thenecessary training anddomain knowledge in thepractice of orthodontics,as well as to havereceived a dedicatedtraining in the use of thesoftware.	CEREC Ortho Softwareis intended for use withimage data acquired fromhandheld intra oral 3Dcameras and desktoplaboratory scanners tocreate 3D virtual modelsto be used for dataacquisition and modelinganalysis for orthodonticpatients and conditions.The CEREC OrthoSoftware 3D model datacan be exported toorthodontic designsoftware to aid in thedesign of orthodonticappliances.	Same
Module	Imports scanned imageof patient	Imports scanned imageof patient	Imports scanned imageof patient	Same
	Stand-alone softwaremodule	Stand-alone softwaremodule	Stand-alone softwaremodule
	Can be used to designdental casts	Can be used to designdental casts	Can be used to designdental casts
	Useful for diagnosis,treatment planning, andCAD design	Useful for diagnosis,treatment planning, andCAD design	Useful for diagnosis,treatment planning, andCAD design
	Virtual planning of toothmovement	Virtual planning of toothmovement	Virtual planning of toothmovement	Same
	Supports .stl files	Supports .stl files	Supports .stl files
Managingpatient andcase base data	Creating, editing,deleting and copyingpatient data	Creating, editing,deleting and copyingpatient data	Creating, editing,deleting and copyingpatient data	Same
	Creating, editing,deleting and copyingcase data	Creating, editing,deleting and copyingcase data	Creating, editing,deleting and copyingcase data
Collection ofstudy material	-	Surface scan for intra-oral scanner	Surface scan for intra-oral scanner	Same
	Surface scan from STLfile	Surface scan from STLfile	Surface scan from STLfile
	CT image data(DICOM)	CT image data(DICOM)	-
	-	2D overlay(PNG, JPG,BMP)	-
	Creation of virtual 3Dvirtual dental models	Creation of virtual 3Dvirtual dental models	Creation of virtual 3Dvirtual dental models
Alignment ofstudy material	Aligning surface scan orCT image	Aligning surface scan orCT image	Creation of virtual 3Dvirtual dental models	Same
	Aligning cephalometricimages	Aligning cephalometricimages	-
	-	Alignment of 2Doverlays	-
	Ability to check/adjustDICOM visibility	Ability to check/adjustDICOM visibility
Measuringstudy material	-	2D measurement toolbox	-	Same
	3D measurement toolbox	3D measurement toolbox	3D measurement toolbox
	Definition of dental Arch shape & length	Definition of dental Arch shape & length	-
Analyzingstudy material	-	Wire length	Wire length
	Tooth widthmeasurements	Tooth widthmeasurements	-
	Tooth and gingivaseparation/segmentation	-	Tooth and gingivaseparation/segmentation	Same
	Bolton's analysis	Bolton's analysis	Bolton's analysis
	Space analysis	Space analysis	Space analysis
	Overjet/overbite	Overjet/overbite	-
	Occlusal mapping	Occlusal mapping	Occlusal mapping
	Treatmentsimulation	-	2D simulation	-
3D simulation		3D simulation	-

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Image /page/7/Picture/0 description: The image shows the logo for LAON iMEDI. The text is in a sans-serif font, with the letters "LAON" and "MEDI" in green. The "i" in "iMEDI" has a small orange square above it, in place of the dot. The logo is simple and modern, and the colors are eye-catching.

404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, Gyeonggi-do, 13511 Korea

+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in green, followed by "iMEDI" also in green, but with a small orange square above the "i". The font is bold and sans-serif.

404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, Gyeonggi-do, 13511 Korea

+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in green, followed by a small orange square above the "i" in "iMEDI", which is also in green. The logo is simple and modern, with a focus on the company name.

404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si,

+82 31 8017 7145 | qna@laon-medi.com | laon-medi.com

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

1) Software Validation

Align Studio contains Basic Documentation Level 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.

1. Performance Testing
  Through the performance test, it was confirmed that Align Studio 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)]

No clinical studies were considered necessary and performed.

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 Align Studio 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, Ortho System (K180941) from 3Shape A/S and CEREC Ortho Software (K171122) from Dentsply Sirona.

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.