Vision Series PACS 5.5 is designed and marketed for soft copy reading, communication and storage of studies produced by digital modalities, to include Digital Mammography. Vision Series PACS receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems.

Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.

To support the diagnostic interpretation of Mammography studies, Vision Series PACS will display the full fidelity DICOM image in a non-compressed format. Images will be rendered with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA, on monitors cleared by FDA for use in Digital Mammography. Lossy compressed mammography images and digitized film screen images should not be used for the purpose of primary diagnosis. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Within Vision Series PACS 5.5, the AMICAS Real Time Worklist offers real-time status of radiology activity and provides customizable workflow management capabilities. Communication of critical results is facilitated and documented through optional, and configurable, components within the Real Time Worklist.

Vision Reach is an optional component within the PACS 5.5 offering which provides clinicians secure, proactive communication and access to clinical reports and images.

Order and Report information generated by HIS/RIS and report creation systems are received and displayed in PACS via the transmission of HL7 messaging. For this data. AMICAS is not the creator, but instead the downstream recipient which relies on the validity of data from said systems.

Vision Series PACS must be installed on suitable, commercial-standard hardware. It is the user's responsibility to ensure monitor quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Device Description

AMICAS Vision Series PACS 5.5 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.

AI/ML Overview

The provided text is a 510(k) summary for the AMICAS Vision Series PACS 5.5. It focuses on demonstrating substantial equivalence to a predicate device (AMICAS Vision Series PACS 4.3) rather than detailing specific acceptance criteria and a study to prove meeting those criteria. The submission primarily highlights feature comparisons and general safety considerations.

Therefore, much of the requested information cannot be extracted from this document, as the submission does not include a detailed performance study with specific acceptance criteria as would be found in a clinical trial or performance evaluation for a novel AI device.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not explicitly define acceptance criteria as typically seen for novel device performance (e.g., sensitivity, specificity thresholds). Instead, it presents a comparison of features between the new device and its predicate to demonstrate substantial equivalence.

Feature	Amicas Vision Series PACS 4.3 (predicate)	Amicas Vision Series PACS 5.5	Acceptance Criteria (Implicit)	Reported Performance (Implicit)
Software Only	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Image Measurements	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Multi-planar reformatting	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Volume Rendering	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Maximum Intensity Projection	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Image editing	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Printing	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
DICOM Images	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Lossless JPEG2000 Compression	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Lossy JPEG2000 Compression	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
DICOM Overlay supporting MQSA-requirements	Yes	Yes	Functionality identical to predicate	Achieved (Yes)
Support for all DICOM transfer syntax and photometric interpretations	No	Yes	New functionality added	Achieved (Yes)

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

This information is not provided in the document. The filing mentions "Functional testing is an integral part of Amicas, Inc. Product Development process" and "Amicas Vision Series 5.5 is tested with reference to its Software Requirements Specifications," but gives no details about specific test sets, sample sizes, or data provenance.

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)

This information is not provided in the document. The document refers to "trained and qualified professionals" (radiologists, technologists, and clinicians) as typical users, but not as experts establishing ground truth for testing.

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

This information is not provided in the document.

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 or reported for this submission. The device is a Picture Archiving Communication System (PACS), not an AI-assisted diagnostic tool for which such a study would typically be performed to measure reader improvement. The document mentions "data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems" can be received, but the PACS itself is not presented as an AI-powered diagnostic tool.

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

This information is not applicable/not provided. The device is a PACS, which is an imaging display and management system that always involves a human-in-the-loop for interpretation and diagnosis. It's not a standalone algorithm performing a diagnostic task.

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

This information is not provided in the document. Given the nature of a PACS system, testing would likely focus on functionality, image integrity, and display accuracy, rather than clinical diagnostic ground truth as in a disease detection algorithm.

8. The sample size for the training set

This information is not applicable/not provided. The device is a software system (PACS) for image management and display, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable/not provided. As explained above, the device is not an AI/ML algorithm requiring a training set.

Summary

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K073526

510(k) Summary of Safety and Effectiveness - as required by 21 CFR part 807.92

Date prepared:	December 12 2007
Submitted by:	Amicas, Inc.20, Guest St.Boston, MA 02135MAR 12 2008
Contact:	Patrice Nedelec
Contact email:	pnedelec@amicas.com
Contact Telephone:	617-779-7858 or 617-372-1331
Contact Fax:	806-313-1214
Device Trade Name:	Amicas Vision Series PACS 5.5
Device Common Name:	Picture Archiving Communication System (PACS)
Regulation number:	892.2050
Device Classification:	Class II
Name:	Amicas Vision Series PACS
Predicate Device:	Amicas Vision Series PACS 4.3
Predicate Device Manufacturer:	AMICAS Inc.20 Guest StreetBoston, MA 021235
Predicate Device 510(k) number:	K062477
Date received:	08/24/2006
Decision date:	10/27/2006
Decision:	Substantially equivalent
Panel Code Device reviewed by:	Radiology
Panel Code Device classified by:	Radiology
Product Code:	LLZ
Regulation number:	892.2050
Device Classification:	Class II

Device Description and intended use:

AMICAS Vision Series PACS 5.5 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.

Typical users of Vision PACS Series 5.5 are radiologists, technologists and clinicians.

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Feature	Amicas Vision SeriesPACS 4.3 (predicate)	Amicas Vision SeriesPACS 5.5
Software Only	Yes	Yes
Image Measurements	Yes	Yes
Multi-planar reformatting	Yes	Yes
Volume Rendering	Yes	Yes
Maximum Intensity Projection	Yes	Yes
Image editing	Yes	Yes
Printing	Yes	Yes
DICOM Images	Yes	Yes
Lossless JPEG2000Compression	Yes	Yes
Lossy JPEG2000 Compression	Yes	Yes
DICOM Overlay supportingMQSA-requirements	Yes	Yes
Support for all DICOM transfersyntax and photometricinterpretations	No	Yes

Technological characteristics:

General Safety Considerations

Amicas Vision Series 5.5 software and the computer platform that it is installed on together constitute a system for the interpretation of medical image data by trained and qualified professionals. It is the user's responsibility to ensure that image quality, display quality, environmental lighting and other possible distractions are consistent with the clinical application. Refer to the instruction manuals for your specific computer and display hardware for information regarding installation, calibration and additional safety issues.

Amicas Vision Series 5.5, as its predicate, includes tools for enlarging, highlighting and obscuring portions of an image relative to other portions. Inappropriate application of these tools can result in the obscuration of important anatomy and contribute to an erroneous interpretation. It is the user's responsibility to understand the effect of image manipulation tools and to apply in a manner consistent with the clinical application. The user must review the cautionary statements in the User's guide.

Be sure to limit access to patient data to authorized individuals who are fully trained and qualified to use this equipment.

Part B: Administrative Information - Section A: 510(k) Summary of Safety and effectiveness Page 2 of 3

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Testing:

Amicas Vision Series 5.5 is tested with reference to its Software Requirements Specifications, as documented in the Verification Procedure included in this 510(k) filing.

Functional testing is an integral part of Amicas, Inc. Product Development process, also included in this filing (see section G, Quality Procedure 0019).

The Amicas Quality Assurance Team, per process, independently verifies completeness of all deliverables -to include testing reports and assessment of safety and effectivenessbefore issuing release advisories.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is relatively small compared to the eagle symbol.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAR 1 2 2008

Mr. Patrice J. C. Nedelec Director of Quality AMICAS, Incorporated 20 Guest Street BOSTON MA 02135

Re: K073526

Trade/Device Name: AMICAS Vision Series PACS 5.5 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: December 13, 2007 Received: December 17, 2007

Dear Mr. Nedelec:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/3/Picture/10 description: The image is a circular logo or emblem. It commemorates the centennial of the FDA from 1906-2006. The central design features the letters 'FDA' in a stylized font, with the word 'Centennial' written below. Three stars are arranged beneath the word 'Centennial'. The text around the circle reads 'Food and Drug Administration Centennial'.

Protecting and Promoting Public Health.

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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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K073524

and the comments of the country of the country of the country of the country of the country of the county of the country of the country of the country of the country of the c

Device Name: AMICAS Vision Series PACS 5.5

Indications For Use:

Vision Series PACS imports images and render said images, upon request, within the AMICAS LightBeam Diagnostic Workstation utilizing both lossless (reversible) and lossy (irreversible) compression.

Vision Reach is an optional component within the PACS 5.5 offering which provides clinicians secure, proactive communication and access to clinical reports and images.

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Prescription Use __ レ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Arun Thaker

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) 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).