The AUTOLIGN 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 3D models 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 AUTOLIGN 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

The AUTOLIGN is stand-alone software which utilizes images of the patient's intraoral anatomy from intraoral cameras and/or desktop laboratory scanners to create a 3D virtual dental model that can be used in the same manner as a traditional physical dental model. AUTOLIGN facilitates the segmentation and editing of the 3D virtual digital model as well as analysis which can be used in secondary orthodontic treatment planning. The software allows for measurement- including Bolton analyses. The models and analysis produced by the proposed Software can be exported to an orthodontic laboratory or directly to orthodontic appliance manufacturers for use in orthodontic treatment planning and design of orthodontic appliances. The material used for vacuum pressing (thermoforming) the final device appliances of sequential aligners on the production cast is DURAN®, but those which satisfy all the requirements specified on the Autoling User Manual can also be used.

AI/ML Overview

The provided text describes the AUTOLIGN device and its comparison to predicate devices, but it does not contain specific acceptance criteria, a detailed study proving the device meets those criteria, or the requested information about sample sizes, ground truth establishment, or clinical study details.

The document is a 510(k) summary for the AUTOLIGN device, which is a software tool for orthodontic treatment planning and design. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a detailed clinical validation study with specific performance metrics.

Here's what can be extracted and what is missing based on your request:

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

Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself (e.g., accuracy, sensitivity, specificity for specific measurements or analyses). The "acceptance" is implicitly that the software functions as intended and is as safe and effective as the predicate device.
Reported Device Performance: The document only states that "The software passed the testing and performed per its intended use." No specific performance metrics or quantitative results are provided.

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

Sample Size: Not mentioned.
Data Provenance: Not mentioned.

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)

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.
Ground Truth Establishment: Not mentioned.

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

Not 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

An MRMC study is not mentioned. The study described is a non-clinical software verification and validation, along with a comparison to predicate devices. There is no mention of human readers or AI assistance in a comparative effectiveness context.

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

The document implies standalone testing as it states "The AUTOLIGN underwent software, hardware, integration, verification and validation testing... The software passed the testing and performed per its intended use." However, specific standalone performance metrics (e.g., algorithm accuracy for segmenting teeth, or measuring arch length) are not provided. The device itself is described as "stand-alone software."

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

Not mentioned.

8. The sample size for the training set

Not mentioned, as there is no specific mention of a machine learning model or training set in the context of the device's validation.

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

Not mentioned (for the same reason as point 8).

Summary of what is available from the text:

Device Name: AUTOLIGN
Regulatory Status: Class II medical device (K192847)
Intended Use: Front-end device for managing orthodontic models, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design based on 3D models of patient dentition.
Non-clinical Tests: Software, hardware, integration, verification, and validation testing were performed according to FDA guidance.
Result of Non-clinical Tests: "The software passed the testing and performed per its intended use."
Predicate Device Comparison: The report extensively compares the AUTOLIGN's indications for use and technological characteristics to three predicate devices (Ortho System™, Orchestrate 3D, CEREC Ortho Software) to establish substantial equivalence.

In conclusion, the provided text focuses on regulatory approval through substantial equivalence to predicate devices and general software validation, rather than a detailed clinical study with quantitative acceptance criteria and performance metrics for the AUTOLIGN itself.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.

July 21, 2020

Diorco Co., Ltd. % Edward Park CEO Radios LLC 4408 Tortuga Ln McKinney, Texas 75070

Re: K192847

Trade/Device Name: Autolign Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: June 16, 2020 Received: June 22, 2020

Dear Edward Park:

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 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

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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 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).

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) K192847

Device Name AUTOLIGN

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - Traditional 510(k)

Submitter Information

Company Name:	DIORCO Co., Ltd.
Company Address:	4F, 26, Yeongil-ro, Yeongtong-gu, Suwon-si, Gyeonggi-do, 16705, Korea
Company Phone:	+82-70-5030-3037
Company Fax:	+82-31-205-0942
Contact Person:	HWI JOON PARK, Official Correspondent for DIORCO Co., Ltd.
Date Summary Prepared:	Aug 30, 2019

Device Identification

Trade / Proprietary name:	AUTOLIGN
510(k) Number:	K192847
Regulation Number:	872.5470
Regulation Name:	Orthodontic Plastic Bracket
Classification:	Class II
Product Code:	PNN, LLZ

Predicate Device

Primary predicate device: Ortho System™ (3Shape A/S) - K171634 Reference device: Orchestrate 3D (Orchestrate 3D) - K181112 Reference device: CEREC Ortho Software (Dentsply Sirona) - K171122

Device Description

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appliance manufacturers for use in orthodontic treatment planning and design of orthodontic appliances. The material used for vacuum pressing (thermoforming) the final device appliances of sequential aligners on the production cast is DURAN®, but those which satisfy all the requirements specified on the Autoling User Manual can also be used.

Indications for Use

The use of the AUTOLIGN 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.

Comparison of Indication for Use Statements

The following table compares Indications for Use Statements between the Autolign and the three predicate devices, i.e. Ortho System™, Orchestrate 3D Orthodontic Software, and CEREC Ortho Software. Similar to the other predicate devices, the Autolign is used for managing patient and case base data, collection, alignment, measurement and analysis of study material, treatment of simulation, and virtual appliance design.

AUTOLIGN	Ortho System™	Orchestrate 3DOrthodontic Software	CEREC OrthoSoftware
The AUTOLIGN is	Ortho System™ is	The Orchestrate 3DOrthodontic Software is	CEREC Ortho Software
intended for use as a	intended for use as a	indicated for use as a	is intended for use with
medical front-end device	medical front-end device	front-end software tool	image data acquired
providing tools for	providing tools for	for management of	from handheld intra oral
management of	management of	orthodontic models,	3D cameras and desktop
orthodontic models,	orthodontic models,	systematic inspection,	laboratory scanners to
systematic inspection,	systematic inspection,	detailed analysis,	create 3D virtual models
detailed analysis,	detailed analysis,	treatment simulation and	to be used for data
treatment simulation and	treatment simulation and	virtual appliance design	acquisition and modeling
virtual appliance design	virtual appliance design	options, including dental	analysis for orthodontic
options (Export of	options (Custom Metal	casts, which may be	patients and conditions.
Models, Indirect	Bands, Export of	used for sequential	The CEREC Ortho
Bonding Transfer	Models, Indirect	aligner trays or retainers.	Software 3D model data
Media) based on 3D	Bonding Transfer		can be exported to

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models of the patient's	Media) based on 3D	These applications are	orthodontic design
dentition before the start	models of the patient's	based on 3D models of	software to aid in the
of an orthodontic	dentition before the start	the patient's dentition	design of orthodontic
treatment. It can also be	of an orthodontic	before the start of an	appliances.
applied during the	treatment. It can also be	orthodontic treatment. It
treatment to inspect and	applied during the	can also be applied
analyze the progress of	treatment to inspect and	during the treatment to
the treatment. It can be	analyze the progress of	inspect and analyze the
used at the end of the	the treatment. It can be	progress of the
treatment to evaluate if	used at the end of the	treatment. It can be used
the outcome is consistent	treatment to evaluate if	at the end of the
with the planned/desired	the outcome is consistent	treatment to evaluate if
treatment objectives.	with the planned/desired	the outcome is consistent
The use of the	treatment objectives.	with the planned/desired
AUTOLIGN requires the	The use of the Ortho	treatment objectives.se
user to have the	System™ requires the	of the Orchestrate 3D
necessary training and	user to have the	requires the user to have
domain knowledge in	necessary training and	the necessary training
the practice of	domain knowledge in	and domain knowledge
orthodontics, as well as	the practice of	in the practice of
to have received a	orthodontics, as well as	orthodontics, as well as
dedicated training in the	to have received a	to have received a
use of the software.	dedicated training in the	dedicated training in the
	use of the software.	use of the software.

Comparison of Technological Characteristics

Both AUTOLIGN and 3Shape Ortho System™ Software (K171634) are stand-alone software module. They also import digital patient scan files. All the digital data format used for AUTOLIGN are those which the predicate device is already supporting. Like the other predicate devices, AUTOLIGN can be used to design dental cast.With respect to the AUTOLIGN, the 3D virtual model and finalized analysis can be exported to support orthodontic diagnosis and treatment planning of tooth movement. It supports STL files.

Comparison Item	AUTOLIGN	Ortho System™	Orchestrate 3DOrthodonticSoftware	CEREC OrthoSoftware
Stand-alone softwaremodule	O	O	O	O
Imports scanned imageof patient	O	O	O	O
Can be used to designdental casts	O	O	O	O
Useful for diagnosis,treatment planning, andCAD design	O	O	O	O

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Comparison Item	AUTOLIGN	Ortho System™	Orchestrate 3DOrthodonticSoftware	CEREC OrthoSoftware
Virtual planning of toothmovement	O	O	O	Unknown
Supports .stl files	O	O	O	O
Managing patient and case base data
Creating, editing, deletingand copying patient data	O	O	O	O
Creating, editing, deletingand copying case data	O	O	O	O
Collection of study material
Surface scan for intra-oralscanner	X	O	O	O
Surface scan from STLfile	O	O	O	O
CT image data	X	O (DICOM)	X	X
2D overlay	O (JPG, BMP)	O (PNG, JPG,BMP)	X	X
Creation of virtual 3Dvirtual dental models	O	O	O	O
Alignment of study material
Aligning surface scan orCT image	O (but CT imageis not available)	O	X	O
Aligning cephalometricimages	O	O	X	O
Alignment of 2D overlays(e.g. ideal arch)	O	O	X	O
Ability to check/adjustDICOM visibility	X	O	X	O
DICOM scansegmentation	X	X	X	O
Measuring study material
2D measurement toolbox	O	O	X	O
3D measurement toolbox	X	O	X	O
Analyzing study material
Definition of dental Archshape & length	O	O	O	O
Wire length	X	O	X	O
Tooth widthmeasurements	O	O	X	O
Comparison Item	AUTOLIGN	Ortho System™	Orchestrate 3DOrthodonticSoftware	CEREC OrthoSoftware
Tooth and gingivaseparation/segmentation	O	Unknown	Unknown	O
Bolton's analysis	O	O	X	O
Space analysis	O	O	X	O (Nance andMoyer spaceanalysis)
Overjet/overbite	X	O	O	Unknown
Occlusal mapping	O	O	O	O
Treatment simulation
2D simulation	X	O	X	X
3D simulation	O	O	O	X
Virtual appliance design
Orthodontic appliancesearch	O	O	X	X
Orthodontic appliancevirtual preparation	O	O	O	X
Orthodontic appliancedesign	O	O	O	X
Orthodontic applianceexport	O	O	O	X

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Most comparison items between the subject device and the primary predicate device are identical. However, the other items, which are not identical to the primary predicate device, such as CT image data availability, Ability to check/adjust DICOM visibility, 3D measurement toolbox, Wire length analyzing study material, and 2D treatment simulation, are identical to the other two reference devices.

Non-clinical Tests

The AUTOLIGN underwent software, hardware, integration, verification and validation testing in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Issued on May 11, 2005). The software passed the testing and performed per its intended use.

The AUTOLIGN does not include any physical device, accessory, or component with patient contacting intended use. Therefore, no sterilization, or shelf life analyses were included in support of substantial equivalence. However, we tested the compatibility of accessories from other manufacturers such as 3D scanners, CAD/CAM production machines, dental vacuum forming machines, and dental cast material sheets to mitigate concerns with biocompatibility of the proposed device.

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Conclusion

Based on comparison of indications for use, scientific concept, technological features, technical data, performance testing, and software validation testing, the AUTOLIGN is found to be as safe and as effective as the primary predicate device. And All the results have been reviewed and approved, showing the AUTOLIGN to be substantially equivalent to the primary predicate device.

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.