PACENTRIC CONNECT, TRAVELER AND WEB by FIMREITE SOFTWARE AS

PaCentric is a software only device intended for viewing of images acquired from CT, MR, CR, US and other DICOM compliant medical imaging systems when installed on suitable commercial hardware. Images and data can be captured, stored, communicated, processed, and displayed within the system and or across computer networks at distributed locations. The device is not intended for clinical viewing of mammography images.

Device Description

PaCentric Web is an Internet application for read-only review of external image deliveries. PaCentric Web facilitates the display and/or transfer of clinical DICOM images and reports to a Web browser. PaCentric is ensuring secure and time-limited access to clinical data. The receiver will only have access to the relevant data for a particular delivery. Using PaCentric, patient data can be delivered to a specific recipient anywhere in the world. PaCentric Web gives a qualified user read-only access to an image delivery. Access is given with a key and password, which must be provided by the Sender. PaCentric Web features commonly used tools and features found on DICOM workstations: Preview image icons from which the user may select images to review in full size; Measurements: Distance, Area, Volume, Angle and ratios. Measurement calibration based on information provided by the relevant DICOM tag. The measurements are performed by having the user select a caliper and marking end points by clicking with a mouse button. The results are being displayed and updated in a results area on the screen; Horizontal and Vertical invert, i.e. flipping the image sideways or upside-down; Color maps. A pixel consists of three sets of values from 0 to 255 that together constitute a color or a gray level. Technically, these RGB values are reduced according to desired color hue. A grayscale image therefore will not lose any details in the image for higher or lower values. This function is mostly used for MONOCHROME1 and MONOCHROME2 images; Window-leveling and Brightness control. These Attributes is only used for Images with Photometric Interpretation (0028,0004) values of MONOCHROME1 and MONOCHROME2. They have no meaning for other Images. When working with DICOM images, the user has the ability to make changes to the displayed images, on a global level, by manipulating the Window Level. Tonal changes to specific areas of an image. Window Center DICOM TAG 0028,1050 and Window Width DICOM TAG 0028,1051 specify a linear conversion from stored pixel values (after any Modality LUT or Rescale Slope and Intercept specified in the IOD have been applied) to values to be displayed. Window Center contains the input value that is the center of the window. Window Width contains the width of the window. Note: The terms "window center" and "window width" are not consistently used in practice, nor were they defined in previous versions of the standard. The definitions here are presented for the purpose of defining consistent meanings for identity and threshold transformations while preserving the common practice of using integral values for center and width. Zoom - Image is downloaded in its original size, but the height and width definition can be adjusted and will therefore function as zoom. Language selection. Default language is based on current location derived from the IP address of the viewer. Simple printable report with preview and selectable fields: Display of patient demographics: Sex, age, date of examination, nationality, operator, weight, referring physician, height, performing physician, body surface area (BSA), location, BP, Sender address, Description, Diagnosis, Comments, Images, selectable signature lines. Ability to display up to eight independent image areas at the same time.

AI/ML Overview

The provided document is a 510(k) Pre-market Notification Summary for PaCentric Web, a software-only device intended for viewing DICOM-compliant medical images. This summary indicates that the device is a picture archiving and communications system (PACS) and workstation.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or device performance metrics for PaCentric Web in the traditional sense of a clinical claims study. Instead, it focuses on the device's adherence to voluntary standards and quality assurance measures applied during development.

The "Test Summary" section lists the following quality assurance measures:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Final acceptance testing (Validation)
Performance testing

While these are testing activities, they are not presented with specific numerical acceptance thresholds or measured performance values (e.g., sensitivity, specificity, accuracy, processing speed, image quality metrics) that would typically be a part of a clinical performance study. The description does not provide quantifiable results that could be placed in a "Reported Device Performance" column.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific details on the sample size used for any test sets, nor does it mention the data provenance (e.g., country of origin of the data, retrospective or prospective) for any testing performed. The "Test Summary" lists various testing phases but without the associated data characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not mention the use of experts to establish ground truth for any test set. The type of device (read-only PACS viewer) suggests that the primary "ground truth" would be the integrity and accurate display of the DICOM images themselves, rather than diagnostic outcomes requiring expert consensus.

4. Adjudication Method for the Test Set

Since the document does not describe a test set requiring ground truth establishment by experts, there is no mention of an adjudication method (such as 2+1, 3+1, or none).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor does it provide an effect size of how much human readers improve with AI vs without AI assistance. This type of study is not typically applicable for a read-only PACS viewer.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The document does not describe a standalone performance study in the context of an algorithm's diagnostic accuracy or performance without human intervention. The device itself is a tool for human viewers, so "standalone performance" in the AI sense is not applicable or discussed.

7. Type of Ground Truth Used

Given that PaCentric Web is a read-only PACS viewer, the "ground truth" would relate to the correct display and measurement capabilities of the software as per DICOM standards, rather than diagnostic "ground truth" like pathology or outcomes data. The document implies that testing focused on system functionality, image display accuracy as per DICOM tags, and the correct execution of features like measurements, window-leveling, and zoom. However, the specific type of ground truth used to validate these functions (e.g., reference measurements on calibrated images, comparison to established DICOM viewers) is not explicitly stated.

8. Sample Size for the Training Set

The document describes PaCentric Web as an "Internet application" and a "software device" for viewing images. It is not an AI/ML device that typically involves a "training set" for model development. Therefore, no information on the sample size for a training set is provided.

9. How the Ground Truth for the Training Set Was Established

As the device is not an AI/ML product developed with a training set, the question of how ground truth was established for a training set is not applicable and therefore not addressed in the document.

Summary of Acceptance Criteria and Study Details (Based only on the provided text):

Feature	Detail Provided in Document
Acceptance Criteria & Performance Table	Acceptance Criteria: The document states "PaCentric Web complies with the voluntary standards as detailed in Section 9." (Section 9 is not provided in the extract). It also lists quality assurance measures: Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Final acceptance testing (Validation), Performance testing. Reported Device Performance: No specific quantitative performance metrics (e.g., accuracy, speed) or pass/fail thresholds are reported in the provided text. The document indicates that these quality measures were "applied to the development."
Test Set Sample Size & Data Provenance	Not specified.
Experts for Ground Truth & Qualifications	Not applicable/Not mentioned. The device is a viewer; expert consensus for diagnostic ground truth is not relevant in the context described.
Adjudication Method	Not applicable/Not mentioned.
MRMC Comparative Effectiveness Study	No, not mentioned.
Standalone Performance Study	No, not mentioned.
Type of Ground Truth Used	Implied to be the integrity and accurate interpretation/display of DICOM image data and associated metadata according to DICOM standards. Specific methods or reference standards for validating these functionalities are not detailed.
Training Set Sample Size	Not applicable (not an AI/ML device).
How Training Set Ground Truth Established	Not applicable (not an AI/ML device).

Summary

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Image /page/0/Picture/0 description: The image shows the text "K100Y37 Fimreite SOFTWARE AS". The text "Fimreite" is in a larger, bold font. There is a partial circle to the right of the text. The text appears to be a logo.

510(k): Abbreviated Pre-market Notification Submission

5 510(k) Summary

As required by section 807.92{c}

DEC - 3 2010

510(k) owner'sname:	Fimreite Software AS
Address:	Torggata 26, 3181 Horten, Norway
Phone:	(47) 93 21 56 27
Contact person:	Svein Fimreite
Date of preparation:	29 October 2010
Name of Device	PaCentric Web
Trade Name:	PaCentric Web
Common Name:	Picture Archiving and Communications Systems and Workstation
Classification Name:	21 CFR 892.2050 System, Image Processing, Radiological
Predicate Device:	K062488 iQ-System PACS
Device Description:	PaCentric Web is an Internet application for read-only review of external imagedeliveries.
	PaCentric Web facilitates the display and/or transfer of clinical DICOM imagesand reports to a Web browser. PaCentric is ensuring secure and time-limitedaccess to clinical data. The receiver will only have access to the relevant datafor a particular delivery. Using PaCentric, patient data can be delivered to aspecific recipient anywhere in the world.
	PaCentric Web gives a qualified user read-only access to an image delivery.Access is given with a key and password, which must be provided by theSender.
	PaCentric Web features commonly used tools and features found on DICOMworkstations:
	• Preview image icons from which the user may select images to review infull size
	• Measurements: Distance, Area, Volume, Angle and ratios. Measurementcalibration based on information provided by the relevant DICOM tag. Themeasurements are performed by having the user select a caliper andmarking end points by clicking with a mouse button. The results are beingdisplayed and updated in a results area on the screen.
	• Horizontal and Vertical invert, i.e. flipping the image sideways or upside-down.
	• Color maps. A pixel consists of three sets of values from 0 to 255 thattogether constitute a color or a gray level. Technically, these RGB valuesare reduced according to desired color hue. A grayscale image thereforewill not lose any details in the image for higher or lower values. Thisfunction is mostly used for MONOCHROME1 and MONOCHROME2 images.
	• Window-leveling and Brightness control. These Attributes is only used forImages with Photometric Interpretation (0028,0004) values of
	MONOCHROME1 and MONOCHROME2. They have no meaning for otherImages.
	When working with DICOM images, the user has the ability to makechanges to the displayed images, on a global level, by manipulating theWindow Level. Tonal changes to specific areas of an image. Window CenterDICOM TAG 0028,1050 and Window Width DICOM TAG 0028,1051 specifya linear conversion from stored pixel values (after any Modality LUT or
	Rescale Slope and Intercept specified in the IOD have been applied) to
	values to be displayed. Window Center contains the input value that is thecenter of the window. Window Width contains the width of the window.Note: The terms "window center" and "window width" are not consistentlyused in practice, nor were they defined in previous versions of thestandard. The definitions here are presented for the purpose of definingconsistent meanings for identity and threshold transformations whilepreserving the common practice of using integral values for center andwidth.• Zoom - Image is downloaded in its original size, but the height and widthdefinition can be adjusted and will therefore function as zoom.• Language selection. Default language is based on current location derivedfrom the IP address of the viewer.• Simple printable report with preview and selectable fields: Display ofpatient demographics: Sex, age, date of examination, nationality, operator,weight, referring physician, height, performing physician, body surfacearea (BSA), location, BP, Sender address, Description, Diagnosis,Comments, Images, selectable signature lines• Ability to display up to eight independent image areas at the same time
Intended Users:	Intended users PaCentric Web include radiologists, specialists includingcardiologists, surgeons, chiropractors, dentists and other trained medicalprofessionals who have a need for reviewing clinical data acquired at someother geographic location.
Intended Use:	PaCentric Web is a software device intended for viewing of images acquiredfrom CT, MR, CR, DR, US and other DICOM compliant medical imaging systemswhen installed on suitable commercial standard hardware.Images and data can be captured, stored, communicated, processed, anddisplayed within the system and or across computer networks at distributedlocations.The device is not intended for clinical viewing of mammography images.
Technology:	PaCentric Web use the same functional scientific technology as its predicatedevices including a transfer protocol based on Query/Retrieve within theDICOM standard. In addition, PaCentric uses secure transfer protocols withVeriSign Class 3 Extended Validation SSL CA HTTP with Privacy TLS 1.0, AES with128 bit encryption (High); RSA with 1024 bit exchange for internetcommunication.
Test Summary:	PaCentric Web complies with the voluntary standards as detailed in Section 9.The following quality assurance measures were applied to the development:• Risk Analysis• Requirements Reviews• Design Reviews• Testing on unit level (Module verification)• Integration testing (System verification)• Final acceptance testing (Validation)• Performance testing
Conclusion:	Fimreite Software AS considers features of PaCentric Web substantiallyequivalent to those of the predicate device, but believes that PaCentric shouldbe considered a device with Moderate Level of Concern.

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510(k): Abbreviated Pre-market Notification Submission

Image /page/1/Picture/1 description: The image shows the logo for "Fimreite SOFTWARE AS". The word "Fimreite" is in bold, and the words "SOFTWARE AS" are in a smaller font size below the word "Fimreite". To the right of the word "Fimreite" is a partial circle with three dots inside of it.

・

. .

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Mr. Svein Fimreite Managing Director Fimreite Software AS Torggata 26. Horten. 3181 NORWAY

DEC - 3 2010

Re: K100837

Trade/Device Name: PaCentric Web Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 28, 2010 Received: November 9, 2010

Dear Mr. Fimreite:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Dan

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Fimreite SOFTWARE AS. The word "Fimreite" is in bold, black letters, with "SOFTWARE AS" in smaller letters below. To the right of the word "Fimreite" is a partial circle with three dots inside.

510(k): Abbreviated Pre-market Notification Submission

4 Indications for Use Statement

510(k) Number: K100837

Device Name: PaCentric Web

Indications for Use:

Prescription Use YES (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use NO

(21 CFR 801 Subpart C)

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

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

Division Sign

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K K160837

Fimreite Software AS Torggata 26, 3181 Horten, Norway

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).