Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.

Digitized film screen images must not be reviewed for primary image interpretation.

Mammographic images must not be interpreted using this system.

Device Description

3viseon/surgery™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital Mammograms). 3surgery is an advanced 2D and 3D visualization solution that enables surgeons to quickly and reliably prepare for various types of surgery, by combining 2D scan slices into comprehensive 3D models of the patient.

The software device should not be used during a surgical procedure.

3viseon/surgery™ works with all major medical image formats and can access multiple data stores, across networks or on CD-ROM / DVD. The software runs on any modern Windows based computer with a 3D graphics card that meets the minimum requirements, eliminating the need for specialized hardware.

AI/ML Overview

Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and supporting study for the 3viseon/surgery™ device:

Important Note: The provided 510(k) document is a summary of safety and effectiveness, and primarily focuses on establishing substantial equivalence to predicate devices. As such, it does not contain detailed information about specific performance acceptance criteria or a dedicated study demonstrating the device meets those criteria in the way a more comprehensive study report or clinical trial would. The 510(k) process for this type of device (Picture Archiving Communications System, Image Processing) often relies on demonstrating that the new device's technological characteristics and intended use are similar enough to existing legally marketed devices, implying similar safety and effectiveness without requiring extensive new performance data.

Therefore, the answers below will reflect the information available in the provided document, and will explicitly state when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided 510(k) summary, specific numerical acceptance criteria and corresponding reported device performance metrics are not explicitly stated. The document focuses on comparing the new device's features and intended use to predicate devices to establish substantial equivalence.

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the provided 510(k) summary. The summary focuses on functional similarities and capabilities with predicate devices rather than quantifiable performance metrics against pre-defined criteria.	Not explicitly stated in the provided 510(k) summary for direct comparison against performance acceptance criteria. The document highlights features like 2D review, MPRs, vascular measurements, etc., but doesn't provide quantitative results demonstrating their performance.

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

This information is not provided in the 510(k) summary. There is no mention of a specific test set, its sample size, or the provenance of any data used for performance evaluation.

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 510(k) summary. No details are given about a test set, ground truth establishment, or the involvement of experts in such a process.

4. Adjudication Method for the Test Set

This information is not provided in the 510(k) summary. As no test set for performance evaluation is described, an adjudication method is also not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and 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 done or is not reported in this 510(k) summary. The device, 3viseon/surgery™, is described as a "software based application for picture archiving and communications system" and "advanced 2D and 3D visualization solution." Its purpose is to prepare 3D models and provide various visualization tools for surgeons. The summary explicitly states: "Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals." This indicates it's a visualization and processing tool, not an AI-assisted diagnostic or interpretation tool meant to augment human reader performance in a diagnostic task.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done

A standalone performance evaluation of the algorithm was not done or is not reported in this 510(k) summary. Given the device's function as an imaging and visualization tool (i.e., PACS software) where "Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals," a standalone performance study in the context of diagnostic accuracy would not be applicable or expected for this type of device classification.

7. The Type of Ground Truth Used

This information is not provided in the 510(k) summary. As no specific performance study with a test set is discussed, the type of ground truth used is not mentioned.

8. The Sample Size for the Training Set

This information is not provided in the 510(k) summary. The document does not describe the use of machine learning or AI that would typically involve a training set. The device is presented as a software application for image processing and visualization.

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

This information is not provided in the 510(k) summary. As no training set is discussed, the method for establishing its ground truth is also not mentioned.

Summary of the Study Information:

The provided 510(k) summary for 3viseon/surgery™ primarily focuses on demonstrating substantial equivalence to predicate devices (VOXAR 3D ENTERPRISE, MODEL 6.1 and 3VISEON) by outlining its technological characteristics and intended use. The document does not describe a specific performance study with defined acceptance criteria, test sets, or ground truth methodologies. The device's classification as a "Picture Archiving Communications System" and "System, Image Processing" indicates its role as a tool for managing, processing, and visualizing medical images, rather than an AI-driven diagnostic aid that would typically require extensive performance studies against ground truth. The submission likely relied on design controls, software validation, and a comparison of features to establish equivalence, rather than a prospective clinical performance study.

Summary

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JAN 2 4 2008

K072653

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: November 24, 2007

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Ernst-Jan Viergever Manager R&D 3mensio Medical Imaging BV Jan Steenlaan 3 3723 BS Bilthoven Netherlands Email: ernstjan viergever@3mensio.com

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name: 3viseon/surgery™ Common Name: Picture Archiving Communications System 892.2050 LLZ Device Classification: Name: System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name	System, ImageProcessing,Radiology	System, ImageProcessing,Radiology
Regulation Number	892.2050	892.2050
510(k) Number	K060505	K043097
Device Name	VOXAR 3DENTERPRISE,MODEL 6.1	3VISEON
Product Code	LLZ	LLZ
Decision	SUBSTANTIALLYEQUIVALENT(SE)	SUBSTANTIALLYEQUIVALENT(SE)
Classification Advisory Committee	Radiology	Radiology
Review Advisory Committee	Radiology	Radiology

Device Description: 21 CFR 807 92(a)(4)

The software device should not be used during a surgical procedure.

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510(k) Summary of Safety and Effectiveness

Indications for Use: 21 CFR 807 92(a)(5)

3viseon/surgery™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners). Images and data are captured, stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Image tools are available such as 2D review, orthogonal Multi Planar Reconstructions (MPRs), oblique MPRs, curved/cross-curved MPRs, slab MPRs, AvelP MIP, MinIP, vascular measurements, annotations, reporting, distribution, etc. Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals. Digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must not be interpreted using this system.

Technological Characteristics: 21 CFR 807 92(a)(6)

3viseon/sugery™ is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification 3viseon/sugery™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

3viseon/sugery™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an emblem. The emblem depicts a stylized image of three human profiles facing right, overlaid with three parallel lines that resemble the wings of a bird.

2 4 2008 JAN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3mensio Medical Imaging BV c/o Carl Thomas, Consultant OTech, Inc. 1600 Manchester Way DENTON TX 76210

K072653. Re:

Trade/Device Name: 3viseon/surgery" Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 13, 2008 Received: January 17, 2008

Dear Mr. Thomas:

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 (PMA), 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.

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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 yours,

Nancy C Brogdon

Nancv 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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510(k) Number: K072653

Device Name: 3viseon/surgery™

Indications for Use:

Only DICOM, for presentation images will be captured for display and diagnosis. Analysis of images and diagnosis is not performed by the software but by physicians or trained professionals.

Digitized film screen images must not be reviewed for primary image interpretation.

Mammographic images must not be interpreted using this system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR - Over-The-Counter Use

(21 CFR 807 Subpart C)

thom Whay

Division of Reproductive. Ab 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).