WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.

Device Description

WillCeph is a software device for Cephalometric Analysis & Maxillo-facial Surgical Simulation, Consulting, Diagnosis, Surgical Planning, Analysis, Growth Forecast. It includes features for patient data management, various gallery formats, image fusion and comparing, cephalogram and tracing on digitized X-ray film, treatment simulation (VTO / STO), chart and analysis, superimposition, photo-film image fusion, growth forecast, and PACS integration (Option). It can be used as a client or standalone software on Microsoft Windows 7 or higher.

AI/ML Overview

The provided document, a 510(k) premarket notification for the "WillCeph" device, contains a limited amount of information regarding acceptance criteria and study details. It explicitly states that "No clinical studies were considered necessary and performed." This means there is no study described in this document that proves the device meets specific acceptance criteria through clinical performance.

However, the document does refer to "Non-Clinical Test Summary" and states that "WillCeph ... was designed and developed according to a software development process and was verified and validated." While it doesn't provide specific numerical acceptance criteria or detailed performance reports, it implies that the device was tested against design specifications.

Based on the available information, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As no clinical study was performed, there are no specific performance metrics reported for device clinical performance. The "acceptance criteria" here would be related to software verification and validation, but the document does not detail these criteria or their fulfillment numerically. The comparison table focuses on technological characteristics and intended use, demonstrating substantial equivalence to a predicate device, rather than explicit performance against predefined criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Software designed and developed according to a software development process	"WillCeph was designed and developed according to a software development process"
Software verified and validated	"was verified and validated"
Substantial equivalence to predicate device in intended use and technological characteristics	Demonstrated through comparison table (see below for details)

Summary of Technological Characteristics (extracted from the comparison table, serving as a basis for substantial equivalence, not performance):

Feature	Proposed Device (WillCeph)	Predicate Device (ORTOMED - K131348)
Intended Use	Specialized dental practices for capturing, storing, and presenting patient images and radiographs, aiding in cephalometric analysis, orthodontic and orthognathic treatment planning, and case follow-up. Results interpreted by trained and licensed dental practitioners.	Same as Proposed Device
Type of Use	Prescription Use	Prescription Use
Modality Support	X-ray	X-ray
Component	Client or Standalone software	Client or Standalone software
Operating System	Windows 7 or higher	Windows 2000/XP, Vista and Windows 7
User Interface	Mouse, Keyboard	Mouse, Keyboard
Image Communication Standard	DICOM	DICOM
Patient Data Management	Patient module for registration and file management; Image module for image management.	GESDEN module for patient registration and file management; GESIMAG module for image management.
Patient Database Engine	My SQL / Microsoft® SQL©	Microsoft® SQL©
Image Measurement	Yes (linear, distance, angle)	Yes (linear, distance, angle)
Matching / Adjustment of Photograph to X-ray	Yes	Yes
Cephalometric Analyses	User-configured analysis; Lateral, Frontal, Models Analyses; Photo studies of soft tissues.	User-configured analysis; Lateral, Frontal, Models Discrepancy Studies; Photo studies of soft tissue.
Treatment Planning, Simulation, and Follow-up	Orthodontic treatment (translate, tip, rotate incisors, reposition molars, rotate mandible); Growth Forecast; Growth simulation on traced x-ray; Superimpose growth tracings; VTO – Visual Treatment Objective; STO – Surgical Treatment Objective (orthognathic surgery); Warping and Morphing.	Orthodontic treatment (translate, tip, rotate incisors, reposition molars, auto-rotate mandible); Arch length discrepancy worksheet; CO/CR Conversion Growth Forecast (Ricketts algorithm); Growth simulation on traced x-ray; Superimpose growth tracings; VTO – Visual Treatment Objective; SVTO – Surgical Visual Treatment Objective (orthognathic surgery); Warping and Morphing.

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

Since "No clinical studies were considered necessary and performed," there is no test set in the traditional sense for clinical performance evaluation. The "test set" would implicitly refer to data used for software verification and validation, but details on sample size, country of origin, or retrospective/prospective nature are not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Given the absence of clinical studies, there is no mention of experts or ground truth establishment for a clinical test set. The document focuses on regulatory compliance through substantial equivalence.

4. Adjudication Method for the Test Set

As no clinical test set is described, no adjudication method is mentioned.

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

No MRMC comparative effectiveness study was performed or described. The document does not discuss human reader performance with or without AI assistance.

6. Standalone Performance

The product, WillCeph, is a standalone software that aids in cephalometric analysis. However, its effectiveness is assessed through substantial equivalence to a predicate device, not through a standalone clinical performance study. The statement "Results produced by the software tools are to be interpreted by trained and licensed dental practitioners" indicates human-in-the-loop, but the core functionality is algorithm-only. The document does not provide standalone performance metrics for the algorithm.

7. Type of Ground Truth Used

As no clinical study was performed, there is no explicit mention of ground truth types (e.g., expert consensus, pathology, outcomes data) for clinical performance evaluation. The "ground truth" for software verification and validation would likely be defined by internal software requirements and specifications.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. This suggests the device's functionality is based on established algorithms and calculations for cephalometric analysis, rather than a machine learning model trained on a large dataset for image interpretation.

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

Since no training set is mentioned, there is no information on how ground truth for a training set was established.

In summary: The WillCeph device received 510(k) clearance based on demonstrating substantial equivalence to a legally marketed predicate device (ORTOMED - K131348). This means the FDA determined that the device is as safe and effective as the predicate device, primarily through a comparison of their intended use and technological characteristics, and through non-clinical software verification and validation activities (which are not detailed in terms of their criteria or results). No clinical studies or performance data against specific numerical acceptance criteria were deemed necessary or provided in this submission for device clearance.

Summary

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March 21, 2018

Image /page/0/Picture/1 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

HDX WILL CORP. % Myoung-Joon Lee General Manager #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup. Heungdeok-gu Cheongju-si, Chungcheongbuk-do 28161 KOREAN

Re: K172168

Trade/Device Name: WillCeph Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 22, 2018 Received: January 30, 2018

Dear Myoung-Joon Lee:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 D. O'Hara For

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172168

Device Name WillCeph

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/3/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font.

510(k) Summary

[As Required by 21 CFR 807.92]

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

July 12, 2017

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

•	Name of Sponsor:	HDX WILL CORP.
-	Address:	#105, 106, 201, 202, 203, 204, 38,Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,Cheongju-si, Chungcheongbuk-do, 28161, Korea
•	Contact Name:	Myoung-Joon Lee / General Manager
-	Telephone No.:	+82-43-710-7318
-	Fax No.:	+82-43-710-7312
-	Email Address:	mjlee@iwillmed.com
•	Name of Manufacturer:	Same as sponsor

-Address: Same as sponsor

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

Trade Name: WillCeph
Common Name: ● PACS Software
Classification:

Classification Name	System, Image Processing, Radiological
Classification Regulation	21 CFR 892.2050
Product Code	LLZ
Device Class	II
Classification Panel	Radiology

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Image /page/4/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font and is slightly slanted to the right.

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

510(k) Number: K131348 Applicant: ● INFOMED SERVICIOS INFORMATICOS Classification Name: Imaging Processing System ● ● Trade Name: ORTOMED

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

■ Overview

- Description

Cephalometric Analysis & Maxillo-facial Surgical Simulation
Consulting, Diagnosis, Surgical Planning, Analysis, Growth Forecast

- Specification

Patient data management : Patient Database
Various Gallery format & User-defined gallery
Image Fusion & Comparing : Pre / Post Treatment
Cephalogram & Tracing on digitized X-ray film
Treatment Simulation (VTO / STO)
Chart & Analysis / Export into excel file
Superimposition
Photo-Film Image Fusion
Growth Forecast
PACS Integration (Option)

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Image /page/5/Picture/0 description: The image shows the logo for HDX WILL. The logo consists of a green and blue square with the letter 'W' inside, followed by the text 'HDX WILL' in blue. The text is bold and slightly slanted to the right.

■ System Requirements

Client or Standalone
OS : Microsoft Windows 7 or higher
CPU : Intel Core2Duo or higher
Memory : DDR2 2GB or higher
Storage Installation : 100MB free-space

Data storage: depends on size of a data

Monitor : 1024 x 768 or higher
Input device : General keyboard & wheel mouse
Hardware Lock key
OS : Microsoft Windows 7 or higher

Program configuration

Connection method : USB 2.0
Image /page/5/Picture/14 description: The image shows a window with a program's menu. The menu has options such as 'Print' and 'Close'. There is also an 'Exit' button at the bottom of the menu. The number '1' is circled in red twice in the image.

Image /page/5/Picture/15 description: The image shows a software interface, likely for dental or orthodontic analysis, with various panels and data displays. The top section includes menu options such as "Analysis," "Measure," and "Excel," along with methods like "Steiner" and "McNamara Kim." The central area displays a grid of images, including X-rays, photos, and traces, labeled as "Lateral," "Frontal," and "SMV." The left side features patient and study lists, with details like chart number, name, and study date.

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Image /page/6/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in a stylized blue font. The logo is simple and modern, and the colors are bright and eye-catching.

(1) Menu: To print the currently selected screen, or you can exit the program.
(2) Top toolbar: Diagnostic items, measurements, and environment setting is available
(3) Patient editing window:

I) Provides functions such as register new patient, modify, and delete.

II) Selected patient's information of the Study, and the image files can be exported as one output file.
III) Copy the image data in connection with the Will-Master.
(4) Study editing window: Provides functions such as Study registration, modification, deletion and importing/exporting of images.
(5) Output window:

Output the images of the selected Study in the Consultation screen, and provides functions such as Trace, VTO/STO, Growth Forecast, Super Impose, Chart, Gallery, etc.

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Image /page/7/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green and blue square with a white "W" inside, followed by the text "HDX Will" in a bold, blue font. The logo is simple and modern, and the colors are eye-catching.

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

WillCeph is intended for use by specialized dental practices for capturing, storing and presenting patient images and radiographs and to aid in cephalometric analysis, orthognathic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.

7. Technological Characteristics [21 CFR 807.92(a)(6)]

There are no significant differences in the technological characteristics of this device compared to the predicate device which adversely affect safety or effectiveness. Provided below is a table summarizing and comparing the technological characteristics of the WillCeph and the predicate device:

	Proposed Device	Predicate Device
K Number	Not known	K131348
Model Name	WillCeph	ORTOMED
Manufacturer	HDX WILL CORP.	INFOMED SERVICIOS INFORMATICOS
Classification Name	System, Image Processing, Radiological	System, Image Processing, Radiological
Regulatory Number	21 CFR 892.2050	21 CFR 892.2050
Product Code	LLZ	LLZ
Classification	II	II
Intended Use	WillCeph is intended for use by specializeddental practices for capturing, storing andpresenting patient images and radiographsand to aid in cephalometric analysis,orthodontic and orthognathic treatmentplanning and case follow-up. Resultsproduced by the software tools are to beinterpreted by trained and licensed dentalpractitioners.	ORTOMED is intended for use byspecialized dental practices for capturing,storing and presenting patient images andradiographs and to aid in cephalometricanalysis, orthodontic and orthognathictreatment planning and case follow-up.Results produced by the software tools areto be interpreted by trained and licenseddental practitioners.
Type of Use	Prescription Use	Prescription Use
Modality Support	X-ray	X-ray
Component	Client or Standalone software	Client or Standalone software
Operating System	Windows 7 or higher	Windows 2000/XP, Vista and Windows 7
User Interface	Mouse, Keyboard	Mouse, Keyboard
ImageCommunicationStandard	DICOM	DICOM
Patient DataManagement	Patient module for patient registration andfile management.Image module for image management.	GESDEN module for patient registrationand file management.GESIMAG module for image management.
Patient DatabaseEngine	My SQL / Microsoft® SQL©	Microsoft® SQL©
	Proposed Device	Predicate Device
ImageMeasurement	Yes (linear, distance, angle)	Yes (linear, distance, angle)
Matching /Adjustment ofPhotograph to X-ray	Yes	Yes
CephalometricAnalyses	In addition to user-configured analysis,standard orthodontic tracing analysesinclude:- Lateral Analyses- Frontal Analyses- Models Analyses- Photo studies of soft tissues	In addition to user-configured analysis,standard orthodontic tracing analysesinclude:- Lateral Analyses- Frontal Analyses- Models Discrepancy Studies- Photo studies of soft tissue
TreatmentPlanning,Simulation andFollow-up	Orthodontic treatment- Translate, tip and rotate incisors,reposition molars, rotate mandible- Growth Forecast- Growth simulation on a traced x-ray ortracing overlaid on photograph- Superimpose one or more growthtracings over original tracingVTO – Visual Treatment ObjectiveSTO – Surgical Treatment Objective(orthognathic surgery)Warping and Morphing	Orthodontic treatment- Translate, tip and rotate incisors,reposition molars, auto-rotate mandible- Arch length discrepancy worksheet- CO/CR Conversion Growth Forecast(Ricketts algorithm)- Growth simulation on a traced x-ray ortracing overlaid on photograph- Superimpose one or more growthtracings over original tracingVTO – Visual Treatment ObjectiveSVTO – Surgical Visual Treatment Objective(orthognathic surgery)Warping and Morphing

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Image /page/8/Picture/0 description: The image shows the logo for Hoxwill. The logo consists of a square with a green top half and a blue bottom half, with a white "W" in the center. To the right of the square is the text "Hoxwill" in blue, with the letters connected to each other.

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Image /page/9/Picture/0 description: The image shows the logo for HDX Will. The logo consists of a green square with a white "W" inside, followed by the text "HDX Will" in blue. The text is in a bold, sans-serif font and is slightly slanted to the right.

Non-Clinical Test Summary

WillCeph contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.

Software information is provided in accordance with FDA guidance: the content of premarket submissions for software contained in medical devices, issued on May 11, 2005.

Clinical Test Summary:

No clinical studies were considered necessary and performed.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

WillCeph has the similar technical characteristics with the predicate devices are intended for use by specialized dental practices for capturing and presenting patient images and radiographs and to aid in cephalometric analysis, orthodontic and orthognathic treatment planning and case follow-up. Results produced by the software tools are to be interpreted by trained and licensed dental practitioners.

The subject and primary predicate device share the same intended use, type of use, modality support and image communication standard. They also share equivalent operating systems. Therefore, WillCeph is substantially equivalent to legally marketed predicate device with respect to indications for use and technology characteristics.

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

In according with the Federal Food & Drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification HDX WILL CORP, concludes that the WillCeph is substantially equivalent in safety and effectiveness to the predicate devices as described herein.

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).