Keosys Medical Imaging Suite (KSWVWR) is intended to be used by trained medical professionals included, but not limited to, radiologists, nuclear medicine physicians and physicists.

Keosys Medical Imaging Suite is a software application intended to aid in diagnostic and evaluation of medical image data. Although this device allows the visualization of mammography images, it is not intended as a tool for primary diagnosis in mammography.

Keosys Medical Imaging Suite can be used for display, process, temporarily store, print and also create and print reports from 2D and 3D multimodal DICOM medical image data. The imaging data can be Computed Tomography (CT), Magnetic Resonance (MR), Radiography X (CR, DX, XRF, MG), Nuclear Medecine (NM) including planar imaging (Static, Whole body, Dynamic, Gated) and tomographic imaging (SPECT, Gated SPECT), Positon Emission Tomography (PT), Ultrasound (US).

Keosys Medical Imaging suite provides tools like rulers, markers or region of interests (e.g. it can be used in an oncology clinical workflow for tumor burden assessment or therapeutic response evaluation).

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.

Device Description

Keosys' Advanced Medical Imaging Software Suite (aka Viewer, aka KSWVWR) is a multimodality diagnostic workstation for visualization and 3D post-processing of Radiological and Nuclear Medicine medical images. It includes dedicated applications for the therapeutic response evaluation process in a multi-vendor, multi-modal and multi time-points context. The solution also includes the latest recommendations for SUV calculation.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and details about the study, as requested.

Note: The provided document is a 510(k) summary for the "Advanced Medical Imaging Software Suite (KSWVWR)". It outlines the device's indications for use and compares it to predicate devices. However, it does not contain detailed acceptance criteria, specific study results, or information about sample sizes, ground truth establishment methods, or expert qualifications for a performance study. The document primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a standalone performance study report. Therefore, many of your requested points cannot be directly addressed from this text.

1. Table of Acceptance Criteria and Reported Device Performance

As noted, the document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a study. The focus is on functionality and equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to display, process, temporarily store, print, and create reports from 2D and 3D multimodal DICOM medical image data.	Stated as a core function and intention of the device.
Support for various imaging modalities (CT, MR, Radiography X, NM, PET, US).	Stated as compatible with these modalities.
Provision of tools like rulers, markers, or regions of interest.	Stated as a feature (e.g., for tumor burden assessment).
Software functionality and performance as described in specifications.	"Performance and functional testing are an integral part of Keosys's software development process." (No specific results provided).
Substantial equivalence to predicate devices regarding intended use, diagnostic aid, display/manipulation/fuse tools, and multi-modality support.	Claimed substantial equivalence based on a comparison of technical characteristics.

2. Sample size used for the test set and the data provenance

The document does not provide details on a specific "test set" with sample sizes or data provenance (e.g., country of origin, retrospective/prospective) for a performance study. The testing mentioned is part of the general software development process.

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

This information is not provided in the document.

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

The document does not describe an MRMC comparative effectiveness study where human readers used the AI. The device is a "viewer" and "software application intended to aid in diagnostic and evaluation." It provides tools but is not explicitly an "AI" in the sense of providing automated diagnostic suggestions or classifications to be compared with human performance with/without its assistance. It enables the display and manipulation of images and provides measurement tools.

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

The document describes the device as a "software application intended to aid in diagnostic and evaluation of medical image data" and that it "provides tools like rulers, markers or region of interests." It is a diagnostic workstation for visualization and 3D post-processing, and its use is by "trained medical professionals." This implies a human-in-the-loop device. There is no mention of a standalone algorithm performance study.

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

This information is not provided in the document.

8. The sample size for the training set

The document does not describe any machine learning or AI components that would historically require a "training set" in the context of supervised learning, nor does it mention a sample size for such.

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

Not applicable, as no training set is described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

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

June 21, 2016

KEOSYS SAS % Ms. Laurence Boy-Machefer Regulatory Affairs and Ouality Assurance Manager 13 Impasse Serge Reggiani, B.P. 10222 Saint Herblain cedex, 44815 FRANCE

Re: K160334

Trade/Device Name: Advanced Medical Imaging Software Suite (KSWVWR) Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 13, 2016 Received: May 16, 2016

Dear Ms. Boy-Machefer:

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. 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 (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 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.

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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 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oolo

Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160334

Device Name

Advanced Medical Imaging Software Suite (KSWVWR)

Keosys Medical Imaging Suite (KSWVWR) is intended to be used by trained medical professionals included, but not limited to, radiologists, nuclear medicine physicians and physicists.

Magnetic Resonance (MR), Radiography X (CR, DX, XA, XRF, MG), Nuclear Medecine (NM) including planar imaging (Static, Whole body, Dynamic, Gated) and tomographic imaging (SPECT), Positon Emission Tomography (PT), Ultrasound (US).

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

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Image /page/3/Picture/1 description: The image is a logo for Keosys Medical Imaging. The logo consists of a large blue circle with a white "K" inside of it. To the right of the circle is the word "KEOSYS" in blue, with the words "MEDICAL IMAGING" underneath it in a smaller font.

510(k) Summary of Safety and Effectiveness

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

Date Prepared:	January 2016.
Submitter:	Keosys S.A.S.
	13, impasse Serge Reggiani, B.P. 10222
	44815 Saint-Herblain cedex, FRANCE
Contact name:	Ms. Laurence Boy-Machefer
Contact Email:	laurence.boy-machefer@keosys.com
Contact Telephone:	00 33 (0)2 53 59 12 90
Contact Fax:	00 33 (0)2 53 59 12 91
Device Trade Name:	Advanced Medical Imaging Software Suite (KSWVWR)
Device Common Name:	Viewer
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
Myrian	Intrasense	K113620
MIM 5.2	MIM Software	K103576
XD	Mirada	K101228
Hermes Medical ImagingSoftware Suite v5.4	Hermes Medical Solutions AB	K140269
Imagys	Keosys S.A.S	K102000

I) Device Description:

II) Indications for Use:

Keosys Medical Imaging Suite (KSWVWR) is intended to be used by trained medical professionals included, but not limited to, radiologists, nuclear medicine physicians and physicists.

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III) Comparison of the technical characteristics between the device and its predicate devices:

The intended use of the Viewer and the Substantial Equivalent devices are similar with regard to the following points:

all of the devices are providing tools to aid the physician in the diagnosis of patient,
all of the devices support display, manipulation and fuse tools,
all of the devices can use medical images from multiple modalities as SPECT, PET, etc.

The indications for use of the Viewer and SE devices are similar for the reasons expressed in the above point.

The target population is globally the same for all the devices.

All of the devices can be used inside the medical environment (within the "intended use" and the "indications for use" limits). Systems requirements differs only slightly.

The devices are not using any energy apart from the electrical needs for the computer power supply. Moreover, there's no energy delivered.

The Viewer and SE devices are all software components which rely on some human factors represented by the user of the device.

The general design of all the devices software appears to be identical, based on available data.

All of the devices have specific manufacturer's software methods and software to address the performance and functional testing.

IV) Testing:

Keosys Medical Imaging Advanced Software Suite 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.

Image /page/4/Picture/15 description: The image contains the logo for Keosys Medical Imaging. The logo features a large, stylized letter "K" in blue, followed by the word "KEOSYS" in a similar blue font. Below "KEOSYS" are the words "MEDICAL IMAGING" in a smaller font, also in blue. The overall design is clean and professional, suggesting a company in the medical technology field.

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).