The HealthMyne PACS software is a Picture Archiving and Communications System (PACS) intended to be used as a Digital Imaging and Communications in Medicine (DICOM) and non-DICOM information and data management system. The HealthMyne PACS software displays, processes, stores, and transfers medical data from original equipment manufacturers (OEMs) that support the DICOM (including DICOM-RT) standard, with the exception of mammography. It provides the capability to store images and patient information from OEM equipment, and perform filtering, digital manipulation and quantitative measurements.

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, and physicians. It is intended to provide image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Device Description

HealthMyne PACS accesses the information in real-time so that current patients and images are available to a clinician. The clinician can filter and search the patient and image metadata to find the desired patient(s) and/or image(s). The clinician can view the images in various hanging protocol layouts. The layouts contain viewports of the slices within the image set, each annotated with patient information. Within the viewports the clinician can manipulate the image using standard tools: scroll, pan, zoom, window and level, and view the location of the slice in other viewports.

AI/ML Overview

Here's a summary of the acceptance criteria and the study information based on the provided text, where available:

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

The provided text does not explicitly list quantitative acceptance criteria for the HealthMyne PACS system (e.g., minimum accuracy, processing speed, etc.). The "Summary of Studies" section generally states that the device "has undergone verification and validation to confirm its functional performance" and "conformance to the following FDA recognized industry standards applicable to PACS devices." It does not provide specific performance metrics against defined criteria.

Therefore, a table of acceptance criteria and reported device performance cannot be generated from this document.

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

The document does not specify the sample size used for any test set, nor does it provide information on data provenance (country of origin, retrospective/prospective). It only mentions "non clinical testing conformance to the following FDA recognized industry standards."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not mention any experts used to establish ground truth for a test set or their qualifications. The nature of the device (a PACS system for managing and displaying images, not for diagnosis) suggests that human expert ground truth for interpretation might not be the primary focus of its validation, compared to, for example, a diagnostic AI algorithm.

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

The document does not describe any adjudication method.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted based on the provided text. The device is a PACS system, not an AI-assisted diagnostic tool designed to directly improve human reader performance for diagnosis.

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

The device itself, HealthMyne PACS, is a "software-only medical device that can manage OEM medical diagnostic images." Its intended use states it "provides image and related information that is interpreted by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings." This indicates it is a standalone system in its function as a PACS, but its output requires human interpretation. The testing described is "non clinical testing conformance to... industry standards" rather than a performance study of diagnostic output.

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

Given the nature of the device as a PACS for managing and displaying images, the concept of "ground truth" as typically applied to diagnostic AI algorithms (e.g., pathology for cancer detection) is not directly applicable. The "ground truth" for verifying this device would likely be related to the accuracy of image display, storage, manipulation, and transfer according to DICOM and other technical standards, rather than clinical diagnostic ground truth. The document mentions "conformance to the following FDA recognized industry standards applicable to PACS devices: DICOM standard for medical diagnostic images, SMPTE display, and the JPEG2000 image standard." This suggests the "ground truth" for testing was adherence to these technical specifications.

8. The sample size for the training set

The document does not mention any training set size. As a PACS system, it primarily manages and displays existing data, rather than being an AI model that learns from a training set in the conventional sense.

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

Not applicable, as no training set or its ground truth establishment is mentioned.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure with three faces in profile, stacked on top of each other, resembling a bird-like shape.

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

August 20, 2015

Healthmyne, Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW BUFFALO, MN 55313

Re: K152186

Trade/Device Name: Healthmyne PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: LLZ Dated: August 4, 2015 Received: August 5, 2015

Dear Mr. Job:

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 devicerelated 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/ResourcesforYou/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,

Robert A Ochs

Robert Ochs, Ph.D. Acting 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) K152186

Device Name HealthMyne PACS

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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Summary of Safety and Effectiveness/510k Summary

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h).

Company	HealthMyne, Inc.918 Deming WayMadison, WI 53717
Contact	Sigrid SchoepelDirector of Regulatory AffairsTelephone: 608-833-2610Email: sigrid.schoepel@healthmyne.com
Preparation Date	June 15, 2015, Revised July 17, 2015
Trade Name	HealthMyne PACS
Classification	Class II per 21 CFR 892.2050Picture Archiving and Communications System
Product Code	LLZ

Marketed Devices

HealthMyne PACS is a new software-only medical device that can manage OEM medical diagnostic images that are compatible with the DICOM standard. It performs functions similar to those currently available in the Horizon Medical Imaging software cleared for marketing via 510(k) K043146 by McKesson Medical Imaging Company.

Device Description

Intended Use

The client software is designed to run on standard personal and business computers. The product is intended to be used by trained medical professionals, including but not limited to radiologists, oncologists, and physicians. It is intended to provide image and related information that is interpreted

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by a trained professional to render findings and/or diagnosis, but it does not directly generate any diagnosis or potential findings.

Comparison with Predicate

HealthMyne PACS performs many diagnostic image management picture archiving and communications functions available in the predicate device as shown in the following comparison chart. Its intended uses are similar to those of the predicate.

Element	Predicate - McKesson (K043146)	Submission - HealthMyne
Device Name	Horizon Medical Imaging	HealthMyne PACS (HM PACS)
510(k) owner	McKesson Medical Imaging Company	HealthMyne, Inc.
Supportsmammography	Yes.	No.
OperatingSystem	The product uses a client-serverarchitecture utilizing Windows andweb-based platforms.	The product uses a client-serverarchitecture utilizing Windows andLinux platforms.
Image storage/compression	Supports JPEG200 and compression.	Supports JPEG2000 and compression.
DICOMcompliant	Yes.	Yes.
Worklists	Yes.	Yes
Filter and searchcapabilities	Yes.	Yes.
Ability to searchstudies	Yes. Specific searchable fields.	Yes. Dynamic (freeform) search andmatching. Also customizable, indexedsearch parameters.
View study-relateddocuments	Yes. Can view reports/documents.	Yes. Presentation states and RT Struct(regions of interest)
Priority "stat"studies	Yes. Customizable priority settings andemail notification.	Yes. Studies with a DICOM priority tag("Stat" studies) are given priority order(top of the list) in the exam view.
Manage pushedstudies	Yes. Configurable whether studies fromother systems can be sent to thisproduct.	Yes. This product supports only pushedstudies. No studies originate within thisproduct.
View current andprior studies atthe same time	Yes. Called anchor (labeled with an A)study and reference (labeled with an R)study.	Yes. Called current study and priorstudy. Prior studies have a large“PRIOR" label in each viewport.
Open studieswith no digitalimages	Yes	No
Re-organizeseries in a study(for viewing)	Yes. Has a thumbnail view and aviewport selector to choose whichviewport to populate. Can save theorder.	Yes. Has a thumbnail view with theability to drag and drop the thumbnailinto a viewport. Cannot save the order.
Element	Predicate - McKesson (K043146)	Submission - HealthMyne
Display all studyimages in oneviewport	Yes. Can choose to make a viewportshow all images within a study.	No.
Create separatedisplays	Yes. Can select to show just a singleseries in a set of windows.	Yes. Can display a viewport as a singleviewport, can select a viewport layoutand add series to it.
Cycle throughseries	Yes. Can show the "next" and"previous" sets of series.	Yes. Can show the "next" and"previous" sets of series.
Image displaymodes	Yes. Static and cine.	Yes. Static and manual cine.
Select images	Yes. There is an active image indicatorand the active image can be chosen.Can flag/bookmark an image.	Yes. There is an active image indicator.The active image can be chosen or isautomatically set based on tool use.
Delete images	Yes. With the right permission andfrom the client/web software.	Yes. Only with PACS admin privilegesand from the admin console.
Sort images	Yes. Can choose a sort order in theviewport layout.	Yes. Sorting and grouping are bysystem-defined rules.
Copy images	Yes. Can copy an image to theclipboard.	No.
Scrolling throughslices	Yes. Linked series are scrolled together.Can perform "power scrolling" to movethrough slices quickly.	Yes. Linked series are scrolled together.Can "swipe" on a scroll bar to movethrough slices quickly. Can lock/unlockscrolling through every image.
Zoom in/out	Yes. Default settings and can zoominteractively.	Yes. Default settings and can zoominteractively.
Magnify an area	Yes. Can select an area of an image andzoom on just that area.	No, though a similar tool allows a userto magnify a region interactively.
Pan an image	Yes	Yes
Standardviewport layouts	Yes. Viewport layouts that areindependent of any modality orcommon features of series.	Yes. Viewport layouts that areindependent of any modality orcommon features of series.
Custom layouts	Yes.	No. Viewport layouts and hangingprotocols are factory-default.
Labels	Yes. There are labels in the viewport forpatient, study, and image information.Can toggle the display on/off.	Yes. There are labels in the viewport forpatient, study, and image information.
Orientationlabels	Yes.	Yes.
Cross-referenceindicator	Yes. There are cross-reference lines toindicate intersection.	Yes. There is a cutline in linkedviewports to indicate intersection.
View DICOMdata	Yes. You can view the DICOMinformation about the patient andstudy, and the pixel information.	Yes. You can view the DICOMinformation about the patient, study,and current image.
Create MPRimages	Yes. Images can be saved only in theadvanced version of the product.	No. MPRs from the external source aresupported/displayed.
Element	Predicate - McKesson (K043146)	Submission - HealthMyne
Window/leveldetermination	Determined by the product's lookuptables (5 variations), the scanner'slookup table, or a histogram.	Determined by a lookup table function(linear) and the W/L values of theimage. If the image has a customlookup table or a fixed W/L, thosesettings are used instead of allowingchanging of W/L.If no W/L, then a histrogram is used.
Window/levelacross series	Yes. W/L settings can be applied toselected images, series, or all visible.	Yes. W/L settings are applied to theactive image and any linked images.
Window/levelpresets	Yes. Factory-default and customer-defined.	Yes. Factory default.
Adjustwindow/level	Yes. Can interactively adjust thewindow and level.	Yes. Can interactively adjust thewindow and level.
Post-processingof images	Yes. Can sharpen/smooth imagesexcept for mammography.	No. No post-processing.
Annotation	Yes. Can add temporary (per session) orpermanent annotations.	Yes. Display only.
Measuring tools	Yes. Linear, scale, angles, and pixelintensity of a point.	Yes. Pixel intensity and location.
Storepresentationstates	Yes. Can group and save visualizationsettings.	No. Only display of presentation states.
Detectimage/patientissues	Yes. Has a "QA" feature to indicatepatient mismatch/image issues.	Yes. Can view patients and studies witherrors.
Print reports	Yes.	No.
Custom hangingprotocols	Yes.	No. Comes with factory-default hangingprotocols.
Custom filters	Yes. Can set filters to affect the studieslisted.	Yes. Can set filters to affect the studieslisted.
Set reading state	Yes. Ability to set study status.	Yes. Can mark a study as read.
Custom searchgroups	No.	Yes. Can set "codes" to index elementsfor searching (for example, referringphysician or sets of exam types) forfaster auto-complete during search.
Display radiationtherapyinformation	Yes. Supports DICOM RT information.	Yes. Supports DICOM RT structures.

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Summary of Studies

The HealthMyne PACS software has undergone verification and validation to confirm its functional performance. Non clinical testing conformance to the following FDA recognized industry standards applicable to PACS devices: DICOM standard for medical diagnostic images, SMPTE display, and the JPEG2000 image standard.

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Conclusion

It is the opinion of HealthMyne, Inc. that HealthMyne PACS software is substantially equivalent to similar image management options available in the predicate device. HealthMyne PACS does not include any new indications for use with regards to the management of medical diagnostic images, nor does use of this software result in any new potential hazards.

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).