Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing 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.

Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user.

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 4.3 is software intended to create and display twodimensional and three-dimensional images of anatomy from a series of digitally acquired images.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for K062477:

Noteworthy Observation: This 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (Amicas Light Beam Diagnostic Workstation) based on technological characteristics and functional equivalence, rather than a typical performance study with quantitative acceptance criteria against a clinical ground truth. The "Testing" section describes a software verification process inherent to the product development, not a clinical validation study against a pre-defined performance metric.

1. Table of Acceptance Criteria and Reported Device Performance

Criteria Category	Acceptance Criteria (as implied or stated)	Reported Device Performance
Functional Equivalence to Predicate	All features of the predicate device (Amicas LightBeam Workstation) must be present in the new device (Amicas Vision Series PACS 4.3). Specific features include: - Software Only - Image Measurements - Multi-planar reformatting - Volume Rendering - Maximum Intensity Projection - Image editing - Printing - DICOM Images (Lossless JPEG2000 & Lossy JPEG2000 Compression)	The device (Amicas Vision Series PACS 4.3) includes all specified features present in the predicate device. Additionally, it has new features not present in the predicate, such as "DICOM Overlay supporting MQSA-requirements" and "DICOM Printing." The table clearly shows "Yes" for all listed predicate features in the new device.
Compliance with Software Requirements	The device is tested with reference to its Software Requirements Specifications.	The device undergoes functional testing as an integral part of Amicas's "VDEV" (Vision Development Elaboration Validation) product development process, with an independent verification of completeness of deliverables and testing reports by the Compliance Department. (No specific quantitative performance metrics are provided for this testing in the summary).
Image Display Fidelity (Mammography Specific)	For diagnostic interpretation of Mammography studies: - Display full fidelity DICOM image in a non-compressed format. - Render images with patient and clinical information clearly displayed as part of the DICOM Overlay as required by MQSA. - Display on monitors cleared by FDA for use in Digital Mammography (at least 5Mpixel resolution and other FDA-accepted technical specifications). - Lossy compressed mammography images and digitized film screen images should not be used for primary diagnosis.	The device's "Indications For Use" explicitly state its design to meet these requirements. It specifies rendering full fidelity DICOM images in non-compressed format for mammography, displaying DICOM Overlay per MQSA, and requiring FDA-approved 5Mpixel+ monitors. It also states that lossy compressed mammography images should not be used for primary diagnosis. (The document asserts compliance via statement of intended use and features, rather than specific test results).
DICOM Compatibility	Receives images acquired from DICOM-compliant medical imaging systems, data from FDA-cleared Computer-Aided Detection systems and other FDA-cleared Image processing systems. Formats and delivers images over a network to an FDA-cleared DICOM printer.	The "Indications For Use" state that it "receives images acquired from DICOM-compliant medical imaging systems" and "formats and delivers images over a network to a FDA-cleared DICOM printer." The technological characteristics also list "DICOM Images" (with compression types) and "DICOM Printing."
User Responsibility/Safety	Users must ensure: - Image quality, display quality, environmental lighting, and other factors are consistent with clinical application. - Understanding of image manipulation tools to avoid obscuring anatomy. - Access to patient data is limited to authorized, trained, and qualified individuals. - Monitor quality, ambient light conditions, and image compression ratios are consistent with the clinical application.	The device includes cautionary statements in the user's guide and the 510(k) summary emphasizes the user's responsibility for these aspects, implying the device is safe when used appropriately under these conditions.

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

Sample Size: Not specified. The document refers to "Functional testing" and "Software Requirements Specifications" but does not detail the size or nature of the test dataset (e.g., number of images, cases).
Data Provenance: Not specified. Given the nature of the submission (software functional equivalence), it's highly likely that testing involved synthetic data, internal test cases, or a limited set of de-identified clinical images, but no details are provided regarding origin or prospective/retrospective collection.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified. It's implied that "trained and qualified professionals" (radiologists, technologists, clinicians) would eventually use the system, but their involvement in establishing test set ground truth is not detailed.

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

Adjudication Method: Not specified. Given the focus on functional software testing rather than clinical performance evaluation, a formal clinical adjudication method is unlikely to have been applied in the context of this submission.

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: No, an MRMC comparative effectiveness study was not done.
Effect Size: Not applicable, as no such study was conducted or reported. This device is a PACS system designed for image display and management, not an AI-assisted diagnostic tool.

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

Standalone Performance Study: Not applicable in the traditional sense of an AI algorithm. This device is a Picture Archiving Communication System (PACS), which is a display and management tool. Its "performance" is primarily defined by its functionality, compatibility, and compliance with imaging standards, rather than autonomous diagnostic accuracy. The testing described is against software requirements, not clinical ground truth for diagnostic accuracy.

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

Type of Ground Truth: Not explicitly stated as clinical ground truth. The "Testing" section refers to verification against "Software Requirements Specifications." This implies that the ground truth for testing was the expected behavior and output as defined by the software's functional requirements documents, rather than a clinical gold standard (e.g., pathology, expert consensus on disease presence).

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a PACS software, not an AI/ML model that undergoes a training phase.

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

Ground Truth for Training Set Establishment: Not applicable, as this is not an AI/ML device requiring a training set.

Summary

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K.062477

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

Date prepared:	August, 22 2006
Submitted by:	Amicas, Inc. OCT 27 200620, Guest St.Boston, MA 02135
Contact:Contact email:Contact Telephone:Contact Fax:	Patrice Nedelecpnedelec@amicas.com617-779-7858 or 617-372-1331617-783-7209 or 806-313-1214
Device Trade Name:Device Common Name:Regulation number:Device Classification:Name:Predicate Device:Predicate Device Manufacturer:	Amicas Vision Series PACS 4.3Picture Archiving Communication System (PACS)892.2050Class IIAmicas Vision Series PACSAmicas Light Beam Diagnostic WorkstationAMICAS Inc.20 Guest StreetBoston, MA 021235
Predicate Device 510(k) number:Date received:Decision date:Decision:Panel Code Device reviewed by:Panel Code Device classified by:Product Code:Regulation number:Device Classification:	K02297009/06/200211/22/2002Substantially equivalentRadiologyRadiologyLLZ892.2050Class II

Device Description and intended use:

AMICAS Vision Series PACS 4.3 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 4.3 are radiologists, technologists and clinicians.

Part B: Administrative Information - Section A: 510(k) Summary of Safety and effectiveness Page 1 of 3

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Feature	Amicas LightBeamWorkstation(predicate)	Amicas Vision SeriesPACS 4.3
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 JPEG2000	Yes	Yes
Compression
Lossy JPEG2000 Compression	Yes	Yes
DICOM Overlay supporting	No	Yes
MQSA-requirements
DICOM Printing	No	Yes

Technological characteristics:

General Safety Considerations

Amicas Vision Series 4.3 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 4.3, 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 4.3 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 known as "VDEV" (Vision Development Elaboration Validation), also included in this filing (see section G).

The Amicas Compliance Department, per process, independently verifies completeness of all deliverables -to include testing reports and assessment of safety and effectivenessbefore issuing release authorizations.

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

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Image /page/3/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" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or forms, possibly representing health, people, and services.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT 2 7 2006

Ms. Patrice J.C. Nedelec Director, Compliance AMICAS, Inc. 20 Guest Street, Suite 200 BOSTON MA 02135

Re: K062477

Trade/Device Name: AMICAS Vision Series PACS 4.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 23, 2006 Received: August 24, 2006

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 black and white logo. The logo is circular and contains the text "1906-2006" at the top. Below the text is the letters "FDA" in a bold font. Below the letters is the word "Centennial" in a cursive font. There are three stars below the word "Centennial".

Protecting and Promoting Public Health.

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Page 2 -

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 (OS) 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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: AMICAS Vision Series PACS 4.3

Indications For Use:

Vision Series PACS 4.3 is designed and marketed for soft copy reading, communication, printing 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.

Vision Series PACS formats and delivers images over a network to a FDA-cleared DICOM printer as requested and defined by the user.

Prescription Use (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)

David h. Lyynn

Division of Reproductiv and Radiological Device 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).