ExamVue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians.

The software is a software package used with general purpose computing hardware to receive, store, distribute, process and display images and associated data throughout a clinical environment. The software performs digital image processing, measurement, communication and storage. This device is not indicated for use in mammography.

ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.

Device Description

The ExamVue PACS is a software solution for the storage, sharing, display and viewing for diagnosis of medical images. It consists of two software components, a central database and server software that holds, receives and distributes images, and a viewer program that can be installed on multiple computers for viewing. modifying, making measurements on, and displaying the images in the database.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called "ExamVue PACS." This document primarily focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through a clinical study.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment from a clinical study are not present in the provided document.

However, I can extract the information that is available and indicate what is missing.

Missing Information Disclaimer: The provided document is a 510(k) summary and FDA clearance letter. It is a regulatory submission focused on demonstrating substantial equivalence to existing devices, not a detailed report of a clinical performance study with specific acceptance criteria and outcome metrics for a novel AI device. As such, most of the information required to answer your prompt, particularly regarding the performance evaluation of an AI (which this PACS is not explicitly), specific acceptance criteria, sample sizes, expert ground truthing, and MRMC studies, is not contained within this regulatory submission. The document states that "Software Verification and Validation documentation for ExamVue PACS, as well as bench and clinical testing, have been provided in this submission," but these details are not part of the publicly available text provided.

Here's an attempt to answer your prompt based only on the provided text, highlighting the missing information.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present specific quantitative performance acceptance criteria or report performance metrics in the way a clinical study for a diagnostic AI would. Instead, it demonstrates "substantial equivalence" based on functional characteristics and intended use.

Here's a table reflecting the functional equivalence points made in the document, which serve as the implicit "criteria" for substantial equivalence:

Characteristic / "Acceptance Criteria" (Implicit)	ExamVue PACS Performance (Reported as "Yes" for functionality)	Outcome / Status (relative to predicates)
Intended Use (as described)	Image management for trained professionals, including processing, measurement, communication, storage. Not for mammography. Supports CR and DX DICOM.	Substantially Equivalent (same as predicates)
Performance Standard	21 CFR 892.2050	Meets standard (same as predicates)
Operating System Requirements	Windows 7, 8, or 10	Different specifies, but "does not represent a substantial difference"
Image Archive	Yes	Equivalent (same as predicates)
Image Transfer (DICOM 3.0 Standard)	Yes	Equivalent (same as predicates)
Image Display	Yes	Equivalent (same as predicates)
Patient Search	Yes	Equivalent (same as predicates)
Distance and Angle Measurements	Yes	Equivalent (same as predicates)
Window Level Adjustment	Yes	Equivalent (same as predicates)
Zoom and Magnify Functions	Yes	Equivalent (same as predicates)
Line Profile and Histogram	Yes	Equivalent (same as predicates)
DICOM Directory Reading	Yes	Equivalent (where predicates also "Yes") / Improved (where predicate "No")
DICOM Query/Retrieve	Yes	Equivalent (where predicates also "Yes") / Improved (where predicate "No")
DICOM Import	Yes	Equivalent (same as predicates)
DICOM CD Burn	Yes	Equivalent (same as predicates)
DICOM Print	Yes	Equivalent (same as predicates)
DICOM Tag	Yes	Equivalent (same as predicates)
Display Patient Information Editing	Yes	Equivalent (same as predicates)

Study Proving Acceptance Criteria:

The "study" proving the device meets its (implicit) acceptance criteria for substantial equivalence is the 510(k) submission process itself, which includes:

Comparison with Predicate Devices: A detailed comparison chart (Exhibit 1) highlighting functional similarities.
Software Verification and Validation (V&V): Stated that "Software Verification and Validation documentation for ExamVue PACS, as well as bench and clinical testing, have been provided in this submission." Specific details of this V&V are not provided in the public summary.

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

Sample Size: Not specified in the provided document. The mention of "bench and clinical testing" is made, but no numbers are given for patient cases or images in any test set.
Data Provenance: Not specified. It does not mention the country of origin of data or whether it was retrospective or prospective.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The device is intended for "trained professionals, including physicians, radiologists, nurses and medical technicians," but this refers to the users of the PACS, not necessarily the experts defining ground truth for a performance study.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified. Given this is a PACS submission focused on functional equivalence, a formal adjudication process for diagnostic performance ground truth (like 2+1 or 3+1 for AI) is not detailed.

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

MRMC Study: Not mentioned or implied. This device is a PACS, essentially an image management system. It is not presented as an AI-powered diagnostic aid that would assist human readers in improving their diagnostic accuracy or efficiency. Therefore, an MRMC study comparing human readers with and without "AI assistance" is not relevant to this type of device and is not reported.

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

Standalone Performance: Not applicable and not discussed. The ExamVue PACS is a fundamental image management system (software for receiving, storing, displaying images, etc.), not a diagnostic algorithm itself. Its "performance" is in its ability to correctly handle and display images and associated data according to DICOM standards and without defects, not in generating an AI-driven diagnosis.

7. The Type of Ground Truth Used

Type of Ground Truth: Not explicitly stated as "expert consensus," "pathology," or "outcomes data." For a PACS system, the "ground truth" would likely relate to the integrity of image data, successful transmission and storage, accurate display of DICOM tags, and correct functioning of measurement tools, rather than medical diagnostic truth. It implies functional verification and validation.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable and not reported. This device is not an AI algorithm that undergoes a "training phase" on a dataset. It's a software system.

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

Ground Truth for Training Set Establishment: Not applicable. As it's not an AI/ML algorithm requiring a training set, the concept of establishing ground truth for training data does not apply. The development process would involve software engineering best practices, verification, and validation against functional requirements.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 17, 2017

JPI Healthcare Solutions, Inc. % Mr. William Little Product Manager 52 Newtown Plaza PLAINVIEW NY 11803

Re: K162868 Trade/Device Name: Exam Vue PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: March 3, 2017 Received: March 7, 2017

Dear Mr. Little:

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 (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); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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) K162868

Device Name ExamVue PACS

Indications for Use (Describe)

Exam Vue PACS is an image management system intended to be used by trained professionals, including physicians, radiologists, nurses and medical technicians.

ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality types via DICOM: CR and DX.

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

February 28th, 2017.

1. Company and Correspondant Making the Submission:
  Name: JPI Healthcare Co., LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: +82-2-2108 - 2580 (Ext. 500-504) Fax: +82-2-2108-1180 Contact: John Lim Website: http://www.jpi.co.kr/
1. Identification of Device

Classification Name:	Imaging Processing System, Radiological
Common Name:	Picture Archiving and Communication System (PACS)
Trade/Proprietary Name:	ExamVue PACS

3. Predicate Device

Manufacturer:	Vieworks Co, Ltd
Device:	QXLink
510(k) Number:	K092081
Classification Name:	Imaging Processing System, Radiological
Common Name:	Picture Archiving and Communication System (PACS)
Regulatory Number:	21 CFR 892.2050
Regulatory Class:	II
Product Code:	90 LLZ

Manufacturer:	Televere
Device:	Tigerview Professional
510(k) Number:	K061035
Classification Name:	Imaging Processing System, Radiological
Common Name:	Picture Archiving and Communication System (PACS)
Regulatory Number:	21 CFR 892.2050
Regulatory Class:	II
Product Code:	90 LLZ

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Product Classification Names and Citations 4.

Classification Name:	Imaging Processing System, Radiological
Common Name:	Picture Archiving and Communication System (PACS)
Regulatory Number:	21 CFR 892.2050
Regulatory Class:	II
Product Code:	90 LLZ

న్. Description:

1. Indication for use
  ExamVue PACS is an image management system intended to be used by trained professionals, including but not limited to physicians, nurses and medical technicians.

ExamVue PACS supports receiving, sending, printing, storing and displaying studies received from the following modality type via DICOM: CR and DX.

1. Comparison with Predicate Device:
  JPI Healthcare Co., Ltd, believes that the ExamVue PACS is substantially equivalent to the predicate devices, TigerView Professional and QXLink

All three devices have the same basic structure (a central server database and associated viewers), function (the storage, display and diagnosis of DICOM images) and follow the DICOM protocol. They have similar intended uses, and provide similar suites of tools to fulfil their function.

The ExamVue PACS differs from the predicate devices is user interface and compatible operating systems. We believe this does not represent a substantial difference between the two devices, as the change in system requirements reflect the change in computer technology since the release of the predicate device, and the user interface presents the same essential data and supports similar workflow as the predicate device.

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8. Safety, EMC and Performance Data

Safety testing and documentation was performed in accordance with IEEE 1012-2012, Standard for System and Software Verification and Validation.

Software Verification and Validation documentation for ExamVue PACS, as well as bench and clinical testing, have been provided in this submission.

1. Conclusions:
  In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that ExamVue PACS is safe and effective and substantially equivalent to predicate devices as described herein.

A detailed comparison supporting this conclusion can be found in Exhibit 1, Substantial Equivalence Chart below.

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EXHIBIT 1

SUBSTANTIAL EQUIVALENCE CHART

Characteristics	ExamVue PACS	TigerViewProfessional	QXLink
Manufacturer	JPI HealthcareSolutions, Inc	Televere Systems	Vieworks Co, Ltd
510K Number	K162868	K001035	K092081
Intended use.	ExamVue PACS isan imagemanagement systemintended to be usedby trainedprofessionals,includingphysicians,radiologists, nursesand medicaltechnicians.The software is asoftware packageused with generalpurpose computinghardware to receive,store, distribute,process and displayimages andassociated datathroughout aclinicalenvironment. Thesoftware performsdigital imageprocessing,measurement,communication andstorage. This deviceis not indicated foruse inmammography.ExamVue PACSsupports receiving,sending, printing,	TigerViewProfessional is aclinical softwareapplication thatreceives images anddata from variousimaging sources(eg., radiographicdevices, digitalvideo capturedevice, and genericimage devices suchas scanners). Inaddition, TigerViewProfessionalenables the storageof clinical notes andclinical exam data.It is intended toacquire, display,edit(e.g., resize,adjust contrast,crop, annotate, etc.),review, store, print,and distributeimages usingstandard PChardware	The QXLink is adevice that providesone or morecapabilities relating tothe acceptance,transfer, display,storage, and digitalprocessing of medicalimages. The softwarecomponents providefunctions forperforming operationsrelated to imagemanipulation,enhancement, orquantification.DICOM3.0 standard. It cantransfer imagesprocessed inPACS and printimages with a filmprinter compatiblewith DICOM 3.0 byusing DICOM andNetwork systems.
	storing anddisplaying studiesreceived from thefollowing modalitytypes via DICOM:CR and DX.
Performance Standard	21 CFR 892.2050	21 CFR 892.2050	21 CFR 892.2050
Operating SystemRequirements	Windows 7 orWindows 8 orWindows 10	Windows BasedOperating Systems	Windows BasedOperating Systems
Image Archive	Yes	Yes	Yes
Image Transfer	(DICOM 3.0Standard)	(DICOM 3.0Standard)	(DICOM 3.0Standard)
Image Display	Yes	Yes	Yes
Patient Search	Yes	Yes	Yes
Distance andAngleMeasurements	Yes	Yes	Yes
Window LevelAdjustment	Yes	Yes	Yes
Zoom andMagnify Functions	Yes	Yes	Yes
Line Profile andHistogram	Yes	Yes	Yes
DICOM DirectoryReading	Yes	No	Yes
DICOMQuery/Retrieve	Yes	No	Yes
DICOM Import	Yes	Yes	Yes
DICOM CD Burn	Yes	Yes	Yes
DICOM Print	Yes	Yes	Yes
DICOM Tag	Yes	Yes	Yes
DisplayPatientInformationEditing	Yes	Yes	Yes

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The intended use and environment of the device is the same as the predicate devices, with only minor differences in features that are not integral to the function of the device. For this reason, we believe it is substantially equivalent 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).