INFINITT RT PACS is a software medical device intended to be used for reviewing and assessment of DICOM based datasets which may occur in a radiotherapy environment. It is used by qualified specialist to load and display data generated by different DICOM devices including: RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR and PET. The software can connect to a HIS and provides the radiotherapy specialist with the necessary visualization and image manipulation tools to review, present or compare DICOM, RT related datasets including the geometrical super imposition of 3D plan data. INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Megapixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.

Device Description

Infinitt RT PACS, is a radiation therapy image Management solution dedicated to the oncology department. By using Infinitt RT PACS, the treatment planning system of various vendors can be stored and managed. It also transfers DICOM RT type plan images and information to EMR through HL7or database links.

Infinitt RT PACS, provides the function to acquire and view DICOM data generated from RTP (Radiotherapy Planning) System in the form of DICOM C-Store. Supported data includes CT (Computerized Tomography) DICOM image, DICOM RT PLAN data, DRR (Digitally Reconstruct Radiography) image and DICOM RT-Structure, dose information of DICOM RT-Dose and DVH (Dose-Volume Histogram) data. In addition, it supports Axial, Coronal, Sagittal view to check the location of the corresponding Axial CT image and dose distribution to Coronal, Sagittal View through scout line.

Infinitt RT PACS, provides DICOM conformant services for both short and long-term image storage and retrieval of digital image data. The application uses DICOM as the interface to the external world and enables interoperability between different devices.

Infinitt RT PACS, accepts DICOM association requests for the purpose of storing images and for query and retrieval of images. It also initiates DICOM association requests for the purpose of sending images to an external application entity.

AI/ML Overview

The provided text is a 510(k) summary for INFINITT RT PACS. It outlines the device's intended use, comparison to a predicate device, and a brief mention of non-clinical performance data. However, the document does not contain the detailed information required to answer many of your specific questions about acceptance criteria, study design, sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document states:

"The Validation Test Plan was designed to evaluate output functions, and actions performed by Infinitt RT PACS, 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."

This indicates that a study was performed and acceptance criteria were met, but the specifics of what those criteria were and how the study was conducted (e.g., sample size, expert involvement, ground truth method) are not provided in this public summary.

Therefore, I can only provide limited information based on the text.

Here's a breakdown of what can be inferred and what is not present in the provided document:

Summary of Device Performance and Acceptance Criteria (Based on available information):

The INFINITT RT PACS is a Picture Archiving Communications System (PACS) specifically designed for radiation therapy environments. Its primary function is to review and assess DICOM based datasets, including RT-STRUCTURE, RT-PLAN, RT-DOSE, RT-IMAGE, CR, CT, MR, and PET. It provides visualization and image manipulation tools for review, presentation, or comparison of DICOM and RT-related datasets. The device is not capable of generating new or modified RT plan data.

The document broadly states that the device was assessed and tested, and "passed all predetermined testing criteria" and "demonstrated that the predetermined acceptance criteria were met." However, the specific numerical or qualitative acceptance criteria and the corresponding reported device performance metrics are not detailed in this summary. The performance data section focuses on compliance with standards rather than specific quantitative performance metrics.

Detailed Answers to Your Questions:

A table of acceptance criteria and the reported device performance:
- Not provided in the document. The document states that "predetermined acceptance criteria were met" but does not list those criteria or specific performance results.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided in the document. The document mentions "Validation Test Plan" and "nonclinical testing results" but gives no details on sample size, data origin, or whether the study was retrospective or prospective.
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):
- Not provided in the document. The document mentions "designated individuals performed all verification and validation activities" but does not specify their number, qualifications, or their role in establishing ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided in the document.
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:
- Not applicable/Not provided. This device is a PACS for reviewing, not an AI-assisted diagnostic tool designed to improve human reader performance. The document does not indicate any AI components or MRMC studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable/Not provided. The device is a viewing and management system, not a standalone diagnostic algorithm. The testing described is functional validation of the PACS system itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not provided in the document. The mention of "Validation Test Plan" implies a comparison against some form of expected output or "ground truth," but the nature of this ground truth is not elaborated. Given the device's function as a PACS, the "ground truth" would likely relate to accurate display, retrieval, and manipulation of DICOM data as per specifications, rather than clinical outcomes or pathology.
The sample size for the training set:
- Not applicable/Not provided. This device is a PACS, not an AI model that requires a training set.
How the ground truth for the training set was established:
- Not applicable/Not provided. This device is a PACS, not an AI model that requires a training set.

In conclusion, the provided FDA 510(k) summary for INFINITT RT PACS confirms that non-clinical testing was performed and "predetermined acceptance criteria were met," leading to a determination of substantial equivalence. However, the details of these criteria, the study design, sample sizes, expert involvement, and ground truth methodologies are not included in this public summary document. This document primarily focuses on the device's functionality, its comparison to a predicate device, and compliance with relevant standards and regulations.

Summary

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Image /page/0/Picture/10 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services-USA. To the right of the symbol, the text "FDA U.S. FOOD & DRUG ADMINISTRATION" is displayed in blue. The word "FDA" is in a larger, bolder font compared to the rest of the text.

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

February 13, 2020

Re: K193498

Trade/Device Name: INFINITT RT PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: October 31, 2019 Received: December 17, 2019

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 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

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) K193498

Device Name Infinitt RT PACS

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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	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 contains 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, gray letters. The logo is simple and professional, and it is likely used to represent the company's brand.

K193498

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: December 9, 2019

II. DEVICE

Name of Device: Infinitt RT PACS 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: ProKnow DS (K182855), by ProKnow LLC, 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 sphere on the left side, with the word "INFINITT" in large, bold, blue letters to the right of the sphere. Below the word "INFINITT" is the word "Healthcare" in a smaller font size.

INFINITT RT PACS, is intended for reviewing purposes only and is not capable to generate new or modified RT plan data. Users of INFINITT RT PACS, should be trained medical professionals including, radiologists, oncologists, physicians, medical technologists, and dosimetrists. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA cleared monitor that offers at least 5 Mega-pixel resolution and meets other technical specifications reviewed and accepted by FDA. INFINITT RT PACS, is not intended for diagnostic image review on mobile devices.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject device and predicate are both PACS, which are indicated for 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 subject device has no negative impact on the device safety or efficacy and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.

Functionality	Subject DeviceINFINITT RT PACS	Predicate DeviceProKnow DS(K182855)	If different, Impact on Safety and orEfficacy
HardwareRequirements	OS: Windows 7 or higherProcessor: Intel Core i5or higherMemory: 4GM or moreGraphic card:1920x1080, 32bpp	OS: Windows 7, 10,and macOS HighSierraProcessor: DualCore2.2+ GHz Intel orequivalent processorMemory: 8GBGraphic card: WebGLcompatible graphiccard1280x800 effectivedisplay resolution(1900x1080recommended)	Yes, there are differences in the computerrequirements which are dependent uponsoftware development and implementation.The differences do not raise any newpotential safety risks and therefore, webelieve there is no impact on safety orefficacy for the subject device.
Enterprisedistribution ofimages and datavia Internet orIntranet	Yes	Yes	No differences
NetworkingCommunicationsProtocol - DICOM3.1	Yes	No	Yes, there are differences. The subjectdevice uses the DICOM 3.1 FDA recognizedstandard for network communications anddevice interoperability. The differences donot raise any new potential safety risks andtherefore, we believe there is no impact onsafety or efficacy for the subject device.
Functionality	Subject DeviceINFINITT RT PACS	Predicate DeviceProKnow DS(K182855)	If different, Impact on Safety and orEfficacy
ImageCompression	No compression	No compression	No differences
Supported DICOMStandard SOPClasses	CT Image StorageMR Image StoragePET Image StorageRT Dose StorageRT Structure Set StorageRT Plan StorageRT Ion Plan StorageRT Image StorageSecondary CaptureImage Storage	CT Image StorageMR Image StorageRT Dose StorageRT Structure SetStorageRT Plan StorageRT Ion Plan StorageSpatial Registration	Yes, there are differences in the supportedDICOM SOP Classes. The subject devicecomplies with the FDA recognized DICOMStandard and has been tested. The productfunctions are explained in labeling and doesnot raise any new potential safety risks andtherefore, we believe there is no impact onsafety or efficacy for the subject device.
Worklist	Search FilterSearch CriteriaExamined Patient HistoryPatient ListLatest Plan List	Patient ListFilter WorkspaceFilter PatientPatient Collection	Yes, the difference is how the data isretrieved. This does not raise any newpotential safety risks and therefore, webelieve there is no impact on safety orefficacy for the subject device.
Image DisplayFunction	Slice NavigationWindow/LevelZoomZoom to SelectionPanReset	Slice NavigationWindow/LevelZoomZoom to SelectionZoom to FitPanProbe	There are differences where the subjectdevice does not have the exact features ofthe predicate. The subject device has beenvalidated and features and functions aredocumented in the device labeling. Thedifferences do not raise any new potentialsafety risks and therefore, we believe thereis no impact on safety or efficacy for the subject device.
Annotation/Measurement	Yes	No	The subject device supportsannotation/measurement. The subjectdevice has been validated and features andfunctions are documented in the devicelabeling. The difference does not raise anynew potential safety risks and therefore, webelieve there is no impact on safety orefficacy for the subject device.
Multi-PlanarReformation	Axial, Sagittal, Coronal	Axial, Sagittal, Coronal	No differences
3D VolumeRendering	Yes	No	The subject device supports 3D VolumeRendering, has been validated and featuresand functions are documented in the devicelabeling. The difference does not raise anynew potential safety risks and therefore, webelieve there is no impact on safety orefficacy for the subject device.
Image CaptureTool	Yes	No	The subject device supports an ImageCapture Too, has been validated, andfeatures and functions are documented inthe device labeling. The difference does notraise any new potential safety risks and
Functionality	Subject DeviceINFINITT RT PACS	Predicate DeviceProKnow DS(K182855)	If different, Impact on Safety and orEfficacy
Contouring Tool	No	Yes	therefore, we believe there is no impact onsafety or efficacy for the subject device.The subject device does not support aContouring Tool. The subject device hasbeen validated and features and functionsare documented in the device labeling. Thedifference does not raise any new potentialsafety risks and therefore, we believe thereis no impact on safety or efficacy for thesubject device.
Display ROI	Yes	Yes	No differences
Plan Information	Yes	Yes	No differences
Beam Information	Yes	Yes	No differences
Display DoseDistribution	Yes	Yes	No differences
Isodose LevelSetting	Yes	Yes	No differences
Dose VolumeHistograms	Yes	Yes	No differences
Scorecards	Yes	Yes	No differences
Plan Summation	Dose Composition basedon the image fusion	Dose Compositionbased on the spatialregistration	The difference on how each device handlesPlan Summation. The subject device hasbeen validated and the difference does notraise any new potential safety risks andtherefore, we believe there is no impact onsafety or efficacy for the subject device.
Plan Comparison	Yes	No	The subject device supports PlanComparison, has been validated andfeatures and functions are documented inthe device labeling. The difference does notraise any new potential safety risks andtherefore, we believe there is no impact onsafety or efficacy for the subject device.
DisplayDRR/Portal/Simulator Image	Yes	No	The subject device supportsDRR/Portal/Simulator Image, has beenvalidated and features and functions aredocumented in the device labeling. Thedifference does not raise any new potentialsafety risks and therefore, we believe thereis no impact on safety or efficacy for thesubject device.
HIS Interface	Yes	No	The subject device supports HIS Interface.The subject device has been validated andfeatures and functions are documented inthe device labeling. The difference does notraise any new potential safety risks andtherefore, we believe there is no impact onsafety or efficacy for the subject device.

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Image /page/5/Picture/0 description: The image shows the logo for INFINITT Healthcare. The logo consists of a blue circular emblem on the left, followed by the word "INFINITT" in large, bold, blue letters. Below "INFINITT" is the word "Healthcare" in a smaller, lighter font.

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Image /page/6/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-colored letters.

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Image /page/7/Picture/0 description: The image shows the logo for Infinit Healthcare. The logo consists of a blue sphere on the left, with the word "INFINITT" in large, bold, blue letters to the right of the sphere. Below the word "INFINITT" is the word "Healthcare" in smaller, lighter blue letters.

VII. PERFORMANCE DATA

Nonclinical Testing:

The Infinitt RT PACS, has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by Infinitt RT PACS, 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, Infinitt RT PACS, was found to have a safe and effectiveness profile that is similar to the predicate device.

The following Standards were used to develop Infinitt RT PACS, 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 Infinitt RT PACS, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject 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.

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).