WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use as a comprehensive solution to view, optimize, and post-process diagnostic medical images as an aid to physicians and other healthcare professionals in the evaluation of digital imaging examinations.

Due to special customer requirements based on the imaging modality and clinical focus, WebPAX can be configured with different combinations of clinical applications which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques such as multi-planar reconstruction (MPR).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using cleared monitors intended for mammography display. MPR is not intended for mammography use.

Not intended for diagnostic use on mobile devices.

Device Description

WebPAX consists of a server, typically located in a hospital data center, and one or more client systems used by technicians and physicians. On the server side, WebPAX is a software-only solution that is installed on customer-supplied hardware, such as dedicated computer server or virtual machine. The server-side software communicates with other DICOM-compliant systems and with end-users via standard Intranet and/or Internet mechanisms. On the client side, technicians and physicians access the WebPAX server using standard Internet web browsers, such as Google Chrome and Internet explorer.

WebPAX provides users with the ability to manage, store, and interpret digital medical images, including the following application specific modules:

. Echocardiography Workstation
Cardiovascular MRI Workstation
3D Post Processing (Multi-Planar Reconstruction)

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Software Verification	WebPAX software meets all requirements described in the Software Requirement Specification. Tested on Google Chrome and Microsoft Internet Explorer 11. All tests passed.
Software Validation - Measurement Accuracy	Accuracy for "WebPAX Measurement Accuracy" (Basic measurements, Echocardiography measurements, Cardiovascular MR measurements) assessed by direct comparison to measurements made using the Predicate Device on the exact same DICOM dataset, image, and location(s). WebPAX met the Acceptance Criteria that accuracy be greater than 98%.
Reader Study - 3D Post Processing	Performance of WebPAX's 3D post processing capability (Multi-Planar Reconstruction) is equivalent to that of the predicate Siemens Leonardo Workstation. All scores for WebPAX were at least a 1 (Excellent) or a 2 (Very good). The performance of WebPAX was comparable to that of the predicate Siemens device.
Functionality Comparison	Compared to predicate Siemens Leonardo: - Basic PACS Functions: Yes (DICOM standard) - Generic Tools (Measurements): Yes (DICOM standard, Basic Geometry) - Specialty Tools: Echocardiography: Yes (DICOM standard; predicate does not offer; testing demonstrated performance met established acceptance criteria) - Specialty Tools: Cardiovascular MRI: Yes (ROI Area times Slice Thickness, ROI Grayscale times Scale Factor, ROI Grayscale versus time) - 3D Post Processing (MPR): Yes (comparable performance demonstrated in reader study)

Study Details

1. Sample sizes used for the test set and the data provenance:

Software Validation Report (Measurement Accuracy): The exact number of DICOM datasets/images used for testing measurement accuracy is not explicitly stated. It mentions "exact same DICOM dataset, image, and location(s) within the image" but not the total count.
Reader Study Report (3D Post Processing): Six DICOM datasets representing typical clinical scenarios were used.
Data Provenance: Not explicitly stated for either test. The "typical clinical scenarios" for the reader study imply a retrospective collection of real patient data, but the specific country of origin or whether it was retrospective/prospective is not provided.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Reader Study Report (3D Post Processing): Three board-certified physicians were used. Their qualification is stated as "who routinely read cardiovascular MRI studies."
Software Validation Report (Measurement Accuracy): For measurement accuracy, the "ground truth" was established by measurements from the predicate device. No human experts were involved in establishing ground truth for this specific test; it was a direct device-to-device comparison.

3. Adjudication method for the test set:

Reader Study Report (3D Post Processing): The text mentions that "All scores for WebPAX were at least a 1 (Excellent) or a 2 (Very good)." This suggests a scoring system, but it does not describe an explicit adjudication method (e.g., 2+1, 3+1 consensus). It implies an independent rating by each physician from which the reported scores were derived and compared.
Software Validation Report (Measurement Accuracy): No adjudication method was applicable as the comparison was directly against the predicate device's output.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

Yes, a multi-reader multi-case (MRMC) comparative effectiveness study was done for the 3D post-processing capability (referred to as a "Reader Study Report").
Effect size of how much human readers improve with AI vs without AI assistance: This study was designed to demonstrate equivalence of the WebPAX's 3D post-processing capability to the predicate device, not to show improvement of human readers with AI assistance. The study assessed the performance of the device's output as judged by human readers, rather than the readers' performance with and without the device. The conclusion was "The performance of WebPAX was comparable to that of the predicate Siemens device."

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

Yes, the "Software Validation Report" for measurement accuracy serves as a standalone performance assessment. The WebPAX's measurement functionalities (Basic measurements, Echocardiography measurements, Cardiovascular MR measurements) were directly compared against the predicate device's measurements for the same DICOM data, without human interpretation in the loop for this specific test.

6. The type of ground truth used:

Software Validation Report (Measurement Accuracy): The ground truth was effectively established by the measurements provided by the predicate device.
Reader Study Report (3D Post Processing): The ground truth was expert consensus/evaluation (based on the physicians' scores of 'Excellent' or 'Very Good' for the WebPAX output). While not explicit "ground truth" in the sense of a definitive diagnosis, their assessment of the post-processing quality acted as the reference.

7. The sample size for the training set:

The document does not provide information regarding the sample size for any training set. This device appears to be a PACS system with post-processing capabilities, not necessarily a deep learning AI model that requires a distinct "training set." The performance tests focused on verification, validation of measurements, and a reader study comparing it to a predicate.

8. How the ground truth for the training set was established:

As no information on a training set is provided, this question cannot be answered from the document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized representation of a human figure with three faces in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

Auqust 17, 2016

Heart Imaging Technologies, LLC % Robert M. Judd, Ph.D. President 5003 Southpark Drive, Suite 140 DURHAM NC 27713

Re: K152949 Trade/Device Name: WebPAX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 27, 2016 Received: August 1, 2016

Dear Dr. Judd:

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 O'Hara

For

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

Enclosure

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Indications for Use

510(k) Number (if known) K152949

Device Name WebPAX

Indications for Use (Describe)

Not intended for diagnostic use on mobile devices.

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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510(k) Summary - K152949

Identification of Submitter

Address:	Heart Imaging Technologies, LLC5003 Southpark Drive, Suite 140Durham, NC 27701
Registration Number:	3005107869
Contact Person:	Robert M. Judd, Ph.D.PresidentTelephone: 919-384-5044FAX: 866-457-3694
Date of Preparation:	July 29, 2016
Identification of Device
Trade Name:	WebPAX
Common Name:	Picture archiving and communications system
Regulation Number:	892.2050
Device Class:	II

LLZ

Predicate Devices

Product Code:

PREDICATE DEVICE 1:

Manufacturer:	Siemens Medical Solutions, Inc.
Trade Name:	LEONARDO syngo Cardiology Workstation
Common Name:	Picture archiving and communications system (PACS)
Regulation Number:	892.2050
Device Class:	II
Product Code:	LLZ
510k Number:	K042203

PREDICATE DEVICE 2:

Manufacturer:	Heart Imaging Technologies, LLC
Trade Name:	WebPAX
Common Name:	Picture archiving and communications system (PACS)
Regulation Number:	892.2050
Device Class:	II
Product Code:	LLZ
510k Number:	K051325

Description of Device

(PACS)

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standard Intranet and/or Internet mechanisms. On the client side, technicians and physicians access the WebPAX server using standard Internet web browsers, such as Google Chrome and Internet explorer.

WebPAX provides users with the ability to manage, store, and interpret digital medical images, including the following application specific modules:

. Echocardiography Workstation
Cardiovascular MRI Workstation
3D Post Processing (Multi-Planar Reconstruction)

Indications for Use

Not intended for diagnostic use on mobile devices.

Performance Testing

The following test reports have been provided in support of substantial equivalence:

1. Software Verification Report
  The purpose of this report is to demonstrate that the WebPAX software meets all of the requirements described in the Software Requirement Specification. Testing was conducted with clients running on the two supported web browsers: Google Chrome and Microsoft Internet Explorer 11. All tests passed.
1. Software Validation Report
  The purpose of this report was to validate the performance of the following WebPAX image analysis functionalities: Basic measurements, Echocardiography measurements, and Cardiovascular MR measurements. Testing was conducted with clients running on the two supported web browsers: Google Chrome and Microsoft Internet Explorer 11. [Note: Some functionalities are only available with the Google Chrome browser, and thus were only tested with that browser].

For all Software Validation tests for which the Predicate Device offered the same functionality, the "WebPAX Measurement Accuracy" was assessed by direct comparison to measurements made using the Predicate Device on the exact same DICOM dataset, image,

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and location(s) within the image. In all cases WebPAX met the Acceptance Criteria that accuracy be greater than 98%.

1. Reader Study Report
  The purpose of the Reader Study was to demonstrate that the 3D post processing capability of WebPAX 9.3 is equivalent to that of the predicate Siemens Leonardo Workstation (K042203). Three board-certified physicians who routinely read cardiovascular MRI studies were asked to evaluate six DICOM datasets that represent typical clinical scenarios. All scores for WebPAX were at least a 1 (Excellent) or a 2 (Very good). The performance of WebPAX was comparable to that of the predicate Siemens device.

Substantial Equivalence Discussion

The following table compares WebPAX to the predicate device:

FEATURE	WebPAX	PredicateDevice(SiemensLeonardoK042203)	Comments
Basic PACS Functions
TCP/IP network connectivity	Yes	Yes	DICOM standard
DICOM storage class provider (SCP)	Yes	Yes	DICOM standard
DICOM storage class user (SCU)	Yes	Yes	DICOM standard
Digital image storage	Yes	Yes	DICOM standard
Image visualization	Yes	Yes	DICOM standard
Generic Tools
Distance Measurements	Yes	Yes	DICOM standard
ROI Area Measurements	Yes	Yes	DICOM standard
ROI Grayscale Measurements	Yes	Yes	DICOM standard
Angle Measurements	Yes	Yes	Basic Geometry
Specialty Tools: Echocardiography
Doppler Velocity	Yes	No	DICOM standard
Deceleration Time	Yes	No	DICOM standard
Velocity-Time Integral	Yes	No	DICOM standard
Stress Echo Display	Yes	No	DICOM standard
Specialty Tools: Cardiovascular MRI
Volumes/Mass	Yes	Yes	ROI Area times Slice Thickness
Hyperintensity	Yes	Yes	ROI Area times Slice Thickness
Velocity Encoding	Yes	Yes	ROI Grayscale times Scale Factor
Time-Intensity Curves	Yes	Yes	ROI Grayscale versus time
T2 and T2* Decay	Yes	No	ROI Grayscale versus time
T1 Recovery	Yes	No	ROI Grayscale versus time
3D Post Processing
Multi-Planar Reconstruction	Yes	Yes	For WebPAX, based on WebGL

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Both the WebPAX and Siemens Leonardo devices provide generic PACS functionalities with common measurement tools and basic image processing.

Both devices also provide specialty tools for Cardiovascular MRI that allow assessment of cardiac volumes, masses, blood flow velocities, and time-intensity curves. The performance of these functions for both devices were directly compared. WebPAX also provides users with the ability to fit a monoexponential curve to MRI T2(*) and/or T1 grayscale data based on well-established techniques. WebPAX additionally provides specialty tools for Echocardiography. Although the Siemens Leonardo does not provide Echocardiography functions, all of these are an integral part of the DICOM standard itself and testing demonstrated that performance met established acceptance criteria.

Both devices provide multi-planar reconstruction (MPR) techniques that allow the user to re-slice 3D data into directions other than the original imaging planes. The underlying technology used by WebPAX to achieve this, namely WebGL, is different than that used by the Siemens Leonardo, but a reader study demonstrated equivalent performance.

Summary of Substantial Equivalence

No significant differences were detected when comparing measurements and post-processing results made using the candidate WebPAX system with those of the predicate devices. We conclude that the WebPAX system is substantially equivalent.

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).