Imagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the management, the viewing, the reviewing, the storage and archiving of imaging data, and the related documentations, acquired from a variety of imaging devices. Imagys can also support the management of the imaging parts of a clinical trial workflow including the following steps : quality control, data processing and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical end users are trained medical professionals and clinical trial actors.

The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed Radiography), NM (Nuclear Medecine), PET (Positon Emission Tomography), SC (Secondary Capture), US (Ultrasound), XA (Angiographic), video and more DICOM, or others imaging standards, data accepted by the Imagys solution.

It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and the interpretation monitor specifications are consistent with a clinical diagnostic use of the data.

This device is not indicated for mammography use. Lossy compressed mammography-images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Device Description

Imagys is a computing and software solution designed by experts in medical imaging and telecommunications for the collection, quality control, processing, analysis and visualization of imaging data. Imagys can help to execute olinical trials with secure transfer, management, viewing, printing, storage and archiving of data.

AI/ML Overview

Based on the provided text, the Keosys Imagys device is a Picture Archiving and Communication System (PACS). The 510(k) summary focuses on its functionality for managing, viewing, and archiving medical imaging data, particularly for clinical trials.

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

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

The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., quantitative metrics like sensitivity, specificity, or image quality thresholds) or specific reported device performance metrics in a formal table or detailed section.

The document refers to "specifications that are documented in a Software Test Plan" and mentions "Performance and functional testing are an integral part of Keosys's software development process." However, these specifications and their outcomes are not detailed in this public summary.

Therefore, for this device (a PACS system), the "acceptance criteria" appear to be broadly focused on its ability to:

Collect, quality control, process, analyze, and visualize imaging data.
Securely transfer, manage, view, print, store, and archive data.
Support clinical trial workflows (quality control, data processing, audit trails).
Run on standard PCs and servers compliant with Imagys specifications.
Handle various DICOM and other imaging standards data (CT, MR, CR, NM, PET, SC, US, XA, video).

The "reported device performance" is implicitly that the device meets these functional requirements as evidenced by the FDA's substantial equivalence determination to predicate devices. There are no quantitative performance metrics such as accuracy, precision, or processing speed reported in the document.

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

The document does not specify the sample size of any test set used in a performance study, nor does it provide details on the data provenance (country of origin, retrospective/prospective). It generally discusses "Performance and functional testing" without outlining the datasets used.

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)

The document does not mention the use of experts to establish ground truth for any test set, nor does it specify their number or qualifications. The device is a PACS for data management and visualization, not an AI diagnostic tool requiring expert ground truth for diagnostic accuracy.

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

The document does not describe any adjudication method as no expert evaluation requiring adjudication is mentioned for establishing ground truth on a test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This is consistent with the device being a PACS system for data management, not an AI-powered diagnostic aid meant to improve human reader performance.

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

The document does not describe any standalone algorithm performance testing. The Imagys is described as a "computing and software solution" for data management and visualization, implying human interaction for its intended use, rather than a standalone AI algorithm generating diagnostic outputs.

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

Given that Imagys is a PACS system designed for data management and viewing, rather than a diagnostic tool, the concept of "ground truth" for its performance evaluation would likely relate to the integrity and accuracy of data storage, retrieval, display, and transfer. For example, ensuring that an image stored is identical to an image retrieved, or that image metadata is correctly handled. However, the document does not explicitly define the type of ground truth used for its testing, beyond stating "Imagys is tested according to the specifications that are documented in a Software Test Plan."

8. The sample size for the training set

The document does not mention a training set sample size. This device is a PACS system, which typically relies on software engineering principles and functional testing rather than machine learning training sets.

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

Since no training set is mentioned (as the device is not an AI diagnostic model), there is no information on how ground truth for a training set was established.

Summary

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Image /page/0/Picture/0 description: The image contains the logo for Keosys Medical Imaging. The logo consists of a black circle with a white "K" inside, followed by the word "KEOSYS" in black, block letters. Below "KEOSYS" is the phrase "MEDICAL IMAGING" in smaller, black letters.

K102000

OCT 12 2010

510(k) Summary of Safety and Effectiveness

This summary of safety and effectiveness is provided as part of the Premarket Notification for Imagys in conformance with 21 CFR 807.92.

Date Prepared:	July 2010.
Submitter:	Keosys S.A.S.
	1, impasse Augustin Fresnel, Z.A. du Moulin Neuf, B.P. 227
	44815 Saint-Herblain cedex, FRANCE
Contact name:	Mr. Anthony MOTTIER
Contact Email:	anthony.mottier@keosys.com
Contact Telephone:	00 33 (0)2 40 92 26 13
Contact Fax:	00 33 (0)2 40 92 26 26
Device Trade Name:	Imagys
Device Common Name:	Picture Archiving and Communication System
Device Classification Name:	Picture Archiving and Communication System
Classification Panel:	21 CFR §892.2050
Product code:	LLZ
Device Classification:	Class II
Predicate Devices:

Name	Manufacturer	510(k) number
INTEGRADWeb MPR/MIP	Dynamic Imaging, Inc.	K042313
eFilm Worksattion with Modules	eFilm Medical Inc.	K020995
Visio+ CD Viewer	Keosys S.A.S.	K070606

Device Description:

Indications for Use:

Testing:

Imagys is tested according to the specifications that are documented in a Software Test Plan. Performance and functional testing are an integral part of Keosys's software development process.

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Image /page/1/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird with its wings spread, formed by three overlapping profiles of human faces.

MAR 16 2011

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Anthony Mottier Quality System Manager Keosys S.A.S. I, ImpasseAugustin Fresnel, Z.A. du Moulin Neuf, B.P. 227 Saint-Herblsin, 44815 FRANCE

Re: K102000

Trade/Device Name: Imagys Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 12, 2010 Received: July 15, 2010

Dear Mr. Mottier:

This letter corrects our substantially equivalent letter of October 12, 2010.

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 (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 (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

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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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely Yours,

Mary S Patil

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known):

Device Name: Imagys

Indications For Use:

lmagys (KSNRMAVWRxx, KSNERDxx) is a medical solution for the upload, the secure transfer, the O management, the viewing, the printing, the printing, the storage and archiving of imaging data, and the O related documentations, acquired from a variety of imaging devices. Imaging dual, and the U of the inaging parts of a clinical trial workflow including steps : quality control, data processing C and audit trails. Imagys runs on any standard PC and servers compliant with the Imagys specifications. Typical ( end users are trained medical professionals and clinical trial actors.D 0

The imaging data can be CT (Computed Tomography), MR (Magnetic Resonance), CR (Computed O Radiography), NM (Nuclear Medecine), PET (Positon Emission Roomano), SC (Secondary Capture), US D (Ultrasound), XA (Anglographic), video and more DICOM, or others imaging standards, data accepted by the D Imagys solution.D

It is the user responsibility to check that the ambient luminosity conditions, the images compression ratio and O the interpretation monitor specifications are consistent with a dinical to the data. This device is I not indicated for mammography use. Lossy compressed mammography-images and digitized films area. O images must not be used for primary image interpretations. Mammography images may only handed on a using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical O specifications approved by the FDA.

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, @fficeref-Beviews Concertion (CDFL) ○エレ

(Division Sign-Off)

510K

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Page 1 of 1

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).