Xelis Dental 2.0 by Infinitt Healthcare Co.,Ltd.

Xelis Dental 2.0, is a standard PC based software application used for the display and 3D visualization of DICOM medical image files from CT or CBCT. Xelis Dental 2.0, is intended to be used by authorized healthcare professionals such as radiologists, clinicians, refering physicians and other qualified individuals to retrieve, process, review, store, print, distribute images to assist in diagnosis. Xelis Dental 2.0, also provides 3D visualization, 2D analysis and various MPR (Multi-Planar Reconstruction) functions and can be used as a preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software. Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.

Device Description

Xelis Dental 2.0, is a software device used for viewing and manipulating DICOMcompliant images from CBCT (Cone beam computed tomography). Xelis Dental 2.0 is an advanced, easy-to-use dental software providing various tools to dental facilities. Xelis Dental 2.0. provides a practical tool for 3D (three dimensional) and 2D (two dimensional) viewing to optimize dental treatment planning and placement. This stand-alone, Windows-compatible software provides 3D volume rendering (VR), multi-planar reconstruction (MPR) and image segmentation. Xelis Dental 2.0, offers dental implant planning, canal draw, bone density assessment, segmentation and report functionalities. The subject device (Xelis Dental 2.0) is based upon the predicate device, Xelis Dental, (K102684). Xelis Dental 2.0 has updated the software from the predicate to reflect current computer technology and also has a number of new/improved functions. Both the subject device and the predicate are from INFINITT Healthcare Co. Ltd.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Xelis Dental 2.0 device, structured to answer your specific questions.

Based on the provided document, Xelis Dental 2.0 is a Picture Archiving and Communications System (PACS) software, which is traditionally not subject to the same kind of performance studies as AI/CADe medical devices that provide diagnostic interpretations or measurements. The document indicates that this is software for display, 3D visualization, 2D analysis, MPR functions, and pre-operative planning for dental implants. Its premarket notification (K193369) focuses on demonstrating substantial equivalence to a predicate device (Xelis Dental, K102684) rather than proving performance against specific clinical acceptance criteria in a comparative effectiveness study.

The document emphasizes that "The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices."

Therefore, many of your requested items will be "Not Applicable" or refer to general software validation rather than clinical performance for diagnostic accuracy.

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implied from the document)	Reported Device Performance and Evidence
Functional Equivalence	Device functions similarly to the predicate device (Xelis Dental, K102684) in general function, application, and intended use.	Reported: "The subject device and primary predicate are both PACS, which are indicated for dental medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use." Demonstrated through a detailed comparison table.
Safety and Efficacy	Any new/improved functions or technological advancements do not introduce new or increased safety risks and maintain equivalent efficacy.	Reported: "Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices." Specific differences (e.g., Computer platform & OS, Image Layout, Common toolbar edits, Implant report, Annotation List, DICOM Report Send, Arch List, Bone density color map, Canal Thickness, Auto Project Save) are addressed individually, stating no impact on safety or efficacy.
Software Validation	All input functions, output functions, and actions performed by Xelis Dental 2.0 meet predetermined acceptance criteria from a Validation Test Plan.	Reported: "The Xelis Dental 2.0. PACS has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by Xelis Dental 2.0, and followed the process documented in the Validation Test Plan. ... Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."
Regulatory Compliance	Adherence to relevant standards and regulations (e.g., DICOM, risk management, cybersecurity, software lifecycle processes).	Reported: "The following Standards were used to develop Xelis Dental 2.0, and the device has met all the requirements listed in the Standards except for inapplicable requirements: ISO14971, NEMA PS 3.1 - 3.20 (DICOM), IEC 62304, FDA Guidance on Cyber Security, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

Additional Requested Information:

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate clinical test set for diagnostic performance. The validation testing likely involved a set of DICOM images and system functionalities, but specific numbers for "cases" are not provided. The focus is on software functionality and equivalence, not diagnostic accuracy of an AI algorithm on a patient dataset.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing appears to be internal software validation ("assessed and tested at the factory").
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. The approval is for a PACS and visualization software, not a diagnostic AI/CADe device that requires expert-established ground truth for performance evaluation in a clinical context. The "ground truth" for software validation would be adherence to functional specifications and absence of bugs, not a medical diagnosis.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As this is not a clinical study assessing diagnostic performance, an adjudication method for ground truth is not relevant.
If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study was not done. Xelis Dental 2.0 is described as a visualization and planning tool, not an AI or CADe device intended to assist human readers in making a primary diagnosis or as a detection aid where reader improvement would be measured.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. Xelis Dental 2.0 is a software application for human users to review and manipulate images; it is not an "algorithm" with a standalone diagnostic performance claim.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable in the clinical diagnostic sense. The "ground truth" for this device's validation relates to whether the software functions as designed, displays images correctly, and performs its visualization and planning tasks accurately, as per its specifications and intended use. This is validated through internal software testing against requirements.
The sample size for the training set:
- Not Applicable. Xelis Dental 2.0 is not described as an AI/machine learning device that requires a training set. It is a traditional medical imaging software.
How the ground truth for the training set was established:
- Not Applicable. As it’s not an AI/ML device, there's no training set or ground truth in that context.

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.

Infinitt Healthcare Co., Ltd. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

April 14, 2020

Re: K193369

Trade/Device Name: Xelis Dental 2.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: March 7, 2020 Received: March 11, 2020

Dear Mr. Alletto:

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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or post marketing 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

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health 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) K193369

Device Name Xelis Dental 2.0

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 INFINITT Healthcare. The logo consists of a blue sphere with a white wave design on the left, followed by the word "INFINITT" in large, bold, blue letters. Below the word "INFINITT" is the word "Healthcare" in smaller, gray letters.

K193369

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

I. SUBMITTER

Mr. Sang Wook Cho Chief Quality Officer, Research and Development Center INFINITT Healthcare Co. Ltd. 12F Daerung Post Tower III, 27 Digital-ro 34-gil, Guro-gu, Seoul, 08378, South Korea Tel: +82-2-2194-1631 Fax: +82-2-6969-5455 Email: bigmouse@infinitt.com

Date Prepared: November 14, 2019

II. DEVICE

Name of Device: Xelis Dental 2.0 Common or Usual Name: Picture Archiving Communications System Classification Name: system, image processing, radiological (21 CFR 892.2050) Requlatory Class: II Product Code: LLZ

III. PREDICATE DEVICES

Primary Predicate Device: Xelis Dental, K102684, by INFINITT Healthcare Co. Ltd., CFR 892.2050, Product Code LLZ.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

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Image /page/4/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo features a blue globe-like icon on the left, followed by the word "INFINITT" in bold, blue letters. Below "INFINITT" is the word "Healthcare" in a smaller, lighter font.

preoperative software application used for the planning and verification of dental implants. There is no population and age restrictions for patients using this software.

Xelis Dental 2.0, is not intended for use with or for the primary diagnostic interpretation of Mammography images.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject device and primary predicate are both PACS, which are indicated for dental medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use. Any differences between the predicate and the new device has no impact on safety or efficacy of the new device and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.

Functionality	Subject DeviceXELIS DENTAL2.0	XELIS DENTALK102684Predicate	If different, Impact on Safety and orEfficacy
Computer platform & OS(minimum requirements)	Microsoft Windows7/ Windows 10(32bit & 64 bit)Professional. IBMcompatibleMemory: 8GB ormoreDisk: 2GB free harddisk space	MicrosoftWindows XP/Vistaor higher (32bit &64 bit)Professional IBMcompatibleMemory: 1GBDisk: 200MB freehard disk space	Difference: Computer technologyadvancements since 2010 and does notraise any new potential or increasedsafety risks. Therefore, we believe there isno impact on safety or efficacy of thesubject device.
Enterprise distribution ofimages and data via Internet orIntranet	Yes	Yes	No differences
Networking CommunicationsProtocol - DICOM 3.0	Yes	Yes	No differences
Image Compression:	No compression orLossless	No compressionor Lossless	No differences
Standard Interfaces - Ethernet	Yes	Yes	No differences
Image Storage- Server & on-board hard disk size &compression dependent. Canstore to Short- or Long-TermArchives	Yes	Yes	No differences
Multi-Planar Reformation(MPR) - MPR into any classicplanes (axial, sagittal, coronal,oblique planes) and curved andfree-draw planar reformation.3D image reformation on VR,MIP/MinIP	Yes	Yes	No differences
Image Layout	Yes	No	Difference: The subject device can beconfigured for various user views, e.g. 1up to 4 up including panoramic views. Theadding of these features befits User
Functionality	Subject DeviceXELIS DENTAL2.0	XELIS DENTALK102684Predicate	If different, Impact on Safety and orEfficacy
			viewing and does not modify existing risksor raise any new potential safety risks.Therefore, we believe there is no impacton safety or efficacy of the subject device.
Draw lines or arrows	Yes	Yes	No differences
Write text	Yes	Yes	No differences
Measure distance, angle andarea.	Yes	Yes	No differences
Print image	Yes	Yes	No differences
Common tools for zoom pan,windowing, rotate invert, VOI(Volume of Interest), textoverlay reset all	Yes	Yes	No differences
Common toolbar edits (toolshow/hide)	Yes	No	Difference: The common toolbar can beshown or hidden and also be customizedby the User. The features and functions ofthe Xelis Dental2.0 are described inlabeling so the user will be aware of thesystem functionality. The difference doesnot raise any new or additional potentialsafety risks and therefore, we believethere is no impact on safety or efficacy forthe subject device.
MIP/MinIP –maximum/minimum intensityprojection	Yes	Yes	No differences
Dental volume reformatfunction, such as arch/curve,drawing nerve-canal, axis andresliced based on dental arch	Yes	Yes	No differences
Implant planning, whichprovides simulations of implantplacement, bone-structureanalysis and location of themandibular canal	Yes	Yes	No differences
Reporting - save, DICOM send,or print to standard Windowsprinters	Yes	Yes	No differences
Real size printing	Yes	Yes	No differences
Report PDF export	Yes	Yes	No differences
Template based report	Yes	Yes	No differences
Implant report	Yes	No	Difference: The User can define a defaultreport template and implant reporttemplate, which is populated withpredetermined information as selected bythe User. The feature is described inlabeling so the user will be aware of thesystem functionality. The difference doesnot raise any new or potential safety risksand therefore, we believe there is noimpact on safety or efficacy for the subjectdevice.
Functionality	Subject DeviceXELIS DENTAL2.0	XELIS DENTALK102684Predicate	If different, Impact on Safety and orEfficacy
CD/DVD/USB-burning	Yes	Yes	No differences
Project save	Yes	Yes	No differences
Annotation List function	Yes	No	Difference: This feature will enable theUser to check and manage theinformation of annotations drawn on theimage shown in the layout. Selecting anitem in the list moves the images to thelocation where the annotation is drawn.The feature is described in labeling so theuser will be aware of the systemfunctionality. The difference does notraise any new or potential safety risks andtherefore, we believe there is no impacton safety or efficacy for the subjectdevice.
DICOM Report Send	Yes	No	Difference: Reports can be sent as PDFDICOM format. The feature is describedin labeling so the user will be aware of thesystem functionality. The difference doesnot raise any new or potential safety risks andtherefore, we believe there is noimpact on safety or efficacy for the subjectdevice.
Arch List function	Yes	No	Difference: Images can be analyzed bymaking a Cross-sectional View setting thevertical plane along the curve of the arch.The feature is described in labeling so theuser will be aware of the systemfunctionality. The difference does notraise any new or potential safety risks andtherefore, we believe there is no impacton safety or efficacy for the subjectdevice.
Bone density color map	Yes	No	Difference: Colors can be assigned todifferent bone density and viewed. Thefeature is described in labeling so the userwill be aware of the system functionality.The difference does not raise any new orpotential safety risks and therefore, webelieve there is no impact on safety orefficacy for the subject device.
Canal Thickness function	Yes	No	Difference: The Nerve Drawing function isuseful when consulting patients. XelisDental offers Canal Draw and CanalManager functions. The feature isdescribed in labeling so the user will beaware of the system functionality. Thedifference does not raise any new orpotential safety risks and therefore, webelieve there is no impact on safety orefficacy for the subject device.
Auto Project Save function	Yes	No	Difference: Automatically save theworking state. Auto-saved items can beviewed in the worklist and can beconfigured in detail through options. Thefeature is described in labeling so the user will be aware of the system functionality. The difference does not raise any new or potential safety risks and therefore, we believe there is no impact on safety or efficacy for the subject device.
Functionality	Subject DeviceXELIS DENTAL2.0	XELIS DENTALK102684Predicate	If different, Impact on Safety and orEfficacy
			will be aware of the system functionality.The difference does not raise any new orpotential safety risks and therefore, webelieve there is no impact on safety orefficacy for the subject device.

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Image /page/5/Picture/0 description: The image is a logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left and the word "INFINITT" in large, bold, blue letters on the right. Below the word "INFINITT" is the word "Healthcare" in smaller, gray letters. The circular graphic appears to be a stylized representation of a globe or sphere with a curved line running through it.

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Image /page/6/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue sphere with a wave-like design on the left, followed by the word "INFINITT" in large, bold, blue letters. Below "INFINITT" is the word "Healthcare" in smaller, lighter blue letters.

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Image /page/7/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left, followed by the word "INFINITT" in large, bold, blue letters. Below the word "INFINITT" is the word "Healthcare" in smaller, lighter blue letters. The logo is simple and professional, and the blue color scheme gives it a sense of trust and reliability.

VII. PERFORMANCE DATA

Nonclinical Testing:

The Xelis Dental 2.0. PACS has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate input functions, output functions, and actions performed by Xelis Dental 2.0, and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

Summary:

Based on the performance as documented in the Validation Testing. Xelis Dental 2.0, was found to have a safe and effectiveness profile that is similar to the predicate device.

The following Standards were used to develop Xelis Dental 2.0, and the device has met all the requirements listed in the Standards except for inapplicable requirements:

. ISO14971:2007/(R)2010 (Corrected 4 October 2007), Medical devices -Applications of risk management to medical devices, FDA FR Recognition # 5-40.
. NEMA PS 3.1 - 3.20 (2016, Digital Imaging and Communications in Medicine (DICOM) Set, FDA FR Recognition # 12-300.
IEC 62304:2006, Medical device software - Software life cycle processes, FDA FR Recognition # 13-32.
. FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
. FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005

VIII. CONCLUSIONS

The 510(k) Pre-Market Notification for Xelis Dental 2.0, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The new device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise

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Image /page/8/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue circular graphic on the left, followed by the word "INFINITT" in large, bold, blue letters. Below "INFINITT" is the word "Healthcare" in a smaller font, also in blue. The logo is clean and professional, suggesting a company in the healthcare industry.

any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.

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).