interWORKS is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.

Device Description

InterWorks™ is comprised of software modules that can work together to deliver an integrated solution that provides image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations.

The Image Management module that manages your imaging needs for a Radiology Enterprise. All of the different facets are unified under a single system that acquires, distributes, storages, displays and prints medical images. By interVIEW supporting DICOM 3.0 it can Plug-n-Play with other DICOM 3.0 compliant devices with minimal effort. For Practices that are in need of only Tele-Radiology functionality interVIEW TR will meet all the needs.

The Dictation/Transcription module that provides for reliable creation of Radiology reports for your Radiology Enterprise. Reports are created via Voice Recognition with interSCRIBE VR or Digital Dictation with interSCRIBE DD depending upon the individual preferences of the Radiologist and requirements of the Radiology Enterprise. In either case digital files are created by the Radiologist and sent to transcription worklists for transcribing or editing by transcriptionists using interSCRIBE DT. Once the report has been finalized it is electronically signed by the Radiologist and automatically delivered via fax and/or e-mail to referring physicians.

The Radiology Information System module manages your radiology workflow for your Front Desk, Back Office and Clinical operations. All of the different areas of operations are unified under a single system that extends beyond the physical walls to exchange information and perform transactions with important business partners. Most importantly, the rules engine that drives interFLOW can be tailored.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Avreo interWORKS System (K141556):

Overall Assessment: The provided document is a 510(k) summary for a PACS system, not a detailed clinical study report for a diagnostic AI device. Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, and detailed study design for a diagnostic AI is not present. This submission focuses on demonstrating substantial equivalence to a predicate PACS device (K070755) and primarily addresses functional modifications related to image storage.

Acceptance Criteria and Reported Device Performance

The submission does not outline specific numerical acceptance criteria or quantitative performance metrics typically seen for diagnostic AI devices (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device and success in a regression test.

Acceptance Criteria (Implied)	Reported Device Performance
Functional equivalence to predicate device	"interWORKS is as safe and effective as the predicate device"
Technological characteristics equivalent to predicate device	"technological characteristics demonstrate that they are equivalent to the predicate device."
Proper functioning of modified features (lossy compression)	Tested via "regression test"
Compliance with general controls provisions of the Act	FDA's determination of substantial equivalence (implies this)
No adverse effects on image quality for primary interpretation	Lossy compressed mammography images must not be used for primary image interpretations. Mammographic images only interpreted using FDA cleared display.

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document mentions a "regression test" but does not provide details on the number of cases, images, or subjects used in this test.
- Data Provenance: Not specified. It's likely that the "regression test" used internal data or test cases to verify the functionality of the software changes. There's no indication of clinical data from specific countries or whether it was retrospective or prospective.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "regression test" described is a software verification test, not a clinical study requiring expert ground truth for diagnostic accuracy.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical adjudication method is mentioned as this was not a diagnostic accuracy study.
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 comparative effectiveness study was not done. This submission is for a PACS system, not an AI-assisted diagnostic device. The device's primary function is image management, archiving, and display, not automated interpretation or direct assistance in clinical diagnosis beyond providing the images and related information.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. The device itself is a PACS, an infrastructure component, not an algorithm performing a diagnostic task in isolation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of a clinical diagnostic ground truth. For the "regression test," the "ground truth" would be the expected software behavior and output as defined by the system's specifications.
The sample size for the training set:
- Not applicable. This is not a machine learning or AI algorithm development submission, so there is no mention of a "training set."
How the ground truth for the training set was established:
- Not applicable (as above).

Summary

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K 141554
Page 1 of 2

4050 Azalea Drive, N. Charleston, SC 29405

JUL 0222014

510(k) Summary

l. Date Prepared: 02/20/2014

ll. Submitter:

Avreo, Inc.

4050 Azalea Drive

North Charleston, SC 29405

Fax: 843-571-5996

Contact Person: III.

Alison McKee

Marketing Manager

Avreo, Inc.

866-286-8082

IV. Device Name:

Trade Name:	interWORKS
Common Name:	interWORKS
Classification Name:	Picture Archiving and Communications System (PACS) (21 CFR 892.2050, Product Code LLZ)

Predicate Device: V.

K070755

interWORKS

Class II

Decision Date: 05/08/2007

VI. Device Description and Label:

4 Page

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using interSCRIBE DT. Once the report has been finalized it is electronically signed by the Radiologist and automatically delivered via fax and/or e-mail to referring physicians.

VII. Intended Use:

interWORKS is intended to provide a completely scalable PACS solution for hospitals and other related sites, which will distribute, retrieve archive, and display, data and images from a variety of different This also includes the display of structured reports and modality and information systems. mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

Comparison of Characteristics: VIII.

The modified picture archiving and communications systems (PACS) has the following similarities to those which previously received the 510(k) concurrence:

. Have the same indicated use,
. Use the same operating principle,
. Incorporate the same basic development design, and
Incorporate the same basic workflow design. .

The only modifications that were made are:

Ability to store lossy compressed images for non-mammography studies. .
IX. Tests:

Avreo, Inc. follows the 21 CFR 820 for design control. To test the modifications made to interWORKS, we completed a regression test.

×. Conclusion:
Avreo, Inc. believes that sufficient information is included to reach a determination of substantial equivalence. We conclude that the interWORKS is as safe and effective as the predicate device, and that the technological characteristics demonstrate that they are equivalent to the predicate device.

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Image /page/2/Picture/0 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" around the perimeter. Inside the circle is a stylized symbol of an eagle with three stripes extending from its wing.

Public Health Service

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

July 2, 2014

AVREO, INC. ALISON MCKEE 4050 AZALEA DR N CHARLESTON SC 29405

Rc: K141556

Trade/Device Name: Avreo interWORKS System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: L.Z. Dated: June 6, 2014 Received: June 12, 2014

Dear Ms. McKee:

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 10 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 (sec above) into cither 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.

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

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Page 2-Ms. McKee

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

For

Enclosure

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OEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement before,

510{k) Number (if known)

K141556

Device Name Avreo interWORKS System

Indications for Use (Describe)

interWORKS is intended to provide a completely scalable PACS solution for hospitals and other will distribute, retrieve archive, and dinages from a variety of different modality and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammoerablic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA.

Application areas include imaging central reading rooms and any other locations where trained medical professionals would require access or desire patient information or other patient medical information captured in the system.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Michael D. O'Hara

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this Information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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).