Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and visualization of 3D medical image data derived from CT and MRI scans. It is intended to be used by qualified and trained medial professionals, after proper installation.

Volume Interactions Pte Ltd's Image Processing System is not intended to be used in direct contact with the patient nor is it intended to be connected to equipment that is used in direct contact with the patient.

Device Description

Volume Interactions Image Processing System reads DICOM 3.0 format medical image data sets (and other formats) and displays 3D image reconstructions of these data sets through various user selectable industry standard rendering methods and algorithms. The clinical users can spatially manipulate, process to highlight structures and volumes of interest, and measure distances and volumes in the 3D image reconstructions. The processed data can be stored either as 3D image data in a proprietary format. or as 2D picture projections of the 3D image data in TIFF image format. The system runs on commercially available IBM PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems.

The system consists of three product modules namely, VizDexter™ 2.0, Dextroscope™ and DextroBeam™. The modules are described as follows:

VizDexter™ 2.0 is software that processes tomographic (e.g.: Computer Tomography, Magnetic Resonance Imaging) data and produces stereoscopic 3D renderings for surgery planning and visualization purposes. The software user selectable industry standard rendering methods and algorithms.

Dextroscope™ is an interactive console and display system that allows the user to interact with two hands with the 3D images generated by the VizDexter™ software. The Dextroscope™ user works seated, with both forearms positioned on armrests. Wearing stereoscopic glasses, the user looks into a mirror and perceives the virtual image within comfortable reach of both hands for precise hand-eye coordinated manipulation. The hardware uses various industry standard components.

DextroBeam™ is an interactive console intended for group collaborative discussions with 3D images using a stereoscopic projection system. The DextroBeam™ system uses the base of the Dextroscope™ as the 3D interaction interface with the virtual objects. The monitor of the Dextroscope™ is replaced by a screen projection system, so instead of looking into the mirror of the Dextroscope™, the user looks at large stereoscopic screen projections while working with the virtual data in reach of his hands. This enables the discussion of 3D data sets with other specialists in stereoscopic 3D. The hardware uses various industry standard components.

AI/ML Overview

The provided text is a 510(k) summary for the Volume Interactions Image Processing System (VizDexter™ 2.0, Dextroscope™, and DextroBeam™). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a study.

Therefore, the document does not contain the acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical validation or standalone performance study would. It primarily compares the technological characteristics and intended use of the new device with existing, legally marketed devices.

However, based on the information provided, here's what can be inferred or explicitly stated regarding the device's nature and the lack of specific performance study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not present specific quantitative acceptance criteria or a direct study measuring device performance against such criteria. The "performance" demonstrated is substantial equivalence to predicate devices in functionality and safety. The tables compare features, not quantitative performance metrics.

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

No information is provided regarding a "test set" in the context of a performance study. The submission relies on a comparison of technological characteristics with predicate devices.

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

Not applicable, as no performance study with a test set requiring ground truth establishment is described.

4. Adjudication Method for the Test Set:

Not applicable, as no performance study with a test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No MRMC study is mentioned in the document. The comparison is between the technological features of the device and its predicates, not a comparative effectiveness study involving human readers with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

No standalone performance study for the algorithm itself (VizDexter™ 2.0) is described in terms of specific performance metrics. The document focuses on the system as a whole, including the human interaction components (Dextroscope™, DextroBeam™). The functions described are image processing and visualization, which inherently involve human interpretation.

7. The Type of Ground Truth Used:

Not applicable, as no performance study is detailed that would require a ground truth for evaluation.

8. The Sample Size for the Training Set:

No information is provided regarding a "training set." The device is an "Image Processing System" that utilizes "industry standard rendering methods and algorithms," implying it's not a machine learning model that would require a dedicated training set in the modern sense.

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

Not applicable, as no training set is mentioned.

In summary:

This 510(k) submission is a "substantial equivalence" filing for an image processing and visualization system from 2002. It focuses on demonstrating that the device has similar technological characteristics and intended use as already marketed devices. It does not present clinical performance data, acceptance criteria, or studies of the kind typically expected for AI/ML-driven diagnostic devices today. The "proof" of meeting acceptance criteria is implicitly through the FDA's determination of substantial equivalence based on the comparison of features and the device's classification as a Picture Archiving and Communications System, where the clinician retains responsibility for interpretation.

Summary

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510(K) Summary

The following safety and effectiveness summary has been prepared pursuant to requirement for 510(K) summaries specified in 21CFR 807.92(a)

Submitter Information

Volume Interactions Pte Ltd 5 Shenton Way, #37-04 UIC Building, Singapore 068808

65 6226962 Phone: + 65 62226215 Facsimile:

Contact Person

John Baby, Process Development Manager, QA/RA

Date Prepared

August 26, 2002

Device Name

Trade Name Dextroscope™, DextroBeam™, VizDexter™ 2.0

Common Name

lmage Processing System

Classification Name

Picture Archiving and Communications System (per 21 CFR 892.2050)

Classification Number

LLZ

Devices to which substantial equivalence is being claimed

The Volume Interactions Image Processing System is substantially equivalent to

510(k)Number	Device Name	Manufacturer
K992654	Plug n View 3D, Version 1.0	Voxar Limited
K002519	Vitrea 2, Version 2.1	Vital Images Inc.

Device Description

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Image Processing System Volume Interactions Pte Ltd

stored either as 3D image data in a proprietary format. or as 2D picture projections of the 3D image data in TIFF image format. The system runs on commercially available IBM PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems.

The system consists of three product modules namely, VizDexter™ 2.0, Dextroscope™ and DextroBeam™. The modules are described as follows:

Intended Use

Volume Interactions Pte Ltd's Image Processing System is a medical device for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended to be used by gualified and trained medial professionals, after proper installation.

Comparison of Technological Characteristics

The Volume Interactions Image Processing System is substantially equivalent to Voxar Limited Plug n View 3D, Version 1.0 (K992654) for non measurement features and Vital Images Vitrea 2, Version 2.1 (K002519) for measurements.

Feature	Volume InteractionsImage Processing System(VizDexter ™ 2.0,Dextroscope™,DextroBeam™)	Voxar Plug n View 3D,version 1.0
510(k) number		K992654
Intended use	Intended for the display and3D visualization of medicalimage data derived from CTand MRI scans. It is intendedto be used by qualified andtrained medical professionals,after proper installation.	Intended for use byradiologists, clinicians andreferring physicians toacquire, process, render,review, store, print anddistribute DICOM 3.0complaint image studies,utilizing standard PC
		hardware.
Type of softwareProgram	Stand alone applicationprogram	Stand alone applicationprogram
Software platform used	Windows NT, Windows 2000professional	Windows 95/98/NT
Stereoscopic Interactiveconsole	Dextroscope or DextroBeam	None
Communications	TCP/IP	TCP/IP
Image Format In	DICOM 3.0, Classic SGI, TIFF,RAW	ACR NEMA 2.0, DICOM 3.0
Image Format out	TIFF image format	DICOM 3.0
Image Display	Color CRT orStereoscopic ProjectionSystem	Color/Grayscale, CRT orLaptop LCD
Image Archive	SCSI 10-30 Gbytes, CD-ROM	SCSI 2-20 Gbytes, CD ROM
Printing	No	Printing to standards windowprinters
Prescriptive Device	Prescription use only	Prescription use only
Segmentation byThreshold selection	Yes	Yes (Window level Presets)
MorphologySegmentation Manager	Yes	Yes (Limited)
Segmentation byContour Editor	Yes	Yes (Shape & Sculpt)
Volume Rendering,Triplanar Mode and 3Dview
Simultaneous displayof coronal + saggital+ axial plane	Yes (Triplanar Mode)	Yes (Multi Planar Reformatting(MPR) view)
Translate 3 Planes	Yes	Yes
Display lines ofintersection betweenplanes	Yes (shown as actual 3D planeintersections)	No
Patient orientationLabels	No	Yes
Patient Labels	Yes	Yes
Adjustable text onlabels	Yes	Yes
Borders to highlight"current" plane	Yes	Yes
Resetpan/zoom/orientation	Yes	Yes
Show VolumeRendering andTriplanar viewconcurrently	Yes	Yes (shows Volume Renderingand 3 quadrant views)
Adjustable clipping inTriplanar Mode	Yes	Yes (in 3 quadrant views)
Volume Rendered 3DDisplay mode	Yes	Yes
Polygonal Surfaceobject display mode	Yes	No
Multi-modalityVolume RenderedDisplay mode	Yes	No
MIP Display Mode	No	Yes
Basic Tools
Volume	Yes	Yes
Crop	Yes	Yes (Shape tool)
Cut	Yes	No (only orthogonal cuts)
Pick	Yes	Yes (Selection tool)
Zoom	Yes	Yes
Pitch	Yes	Yes (resolution varies duringimage movement)
View Box	Yes	Unknown
Color andtransparency editing	Yes (Volume Console)	Yes (Active Color Presets)
Image Processing
Rotation	Yes	Yes
Pan	Yes	Yes
Zoom	Yes	Yes
Flip according topatient orientation	Yes (Manual Flipping)	Yes
Opacity	Yes	Yes
Orthogonal clipping	Yes	Yes
Sculpting	Yes (Contour Editor)	Yes (Shape & Sculpt tool)
Window levelprotocols	No	Yes
Image Layout
Show Single Screen	Yes	Yes
Show four quadrantsview (coronal +saggital + axial+ 3D)	No	Yes
Multi-modal volume rendering
3D registration	Yes	No
Multimodal fusion of CT and MR scans	Yes	No
Image Storage
Add captured 3D rendered image to user profiles	Yes (as TIFF files)	Yes
Record movie clips	Yes	Yes
Hardcopy generation
Print to DICOM and NON-DICOM printers	No	Yes
Image Editing Tools	Erase and Restore	Tools for removal of obscuring anatomy
Measurements
Distance	Yes	Yes
Area	No	No
Volume	Yes	Yes
Feature	Volume InteractionsImage Processing System(VizDexterTM 2.0,DextroscopeTM,DextroBeamTM)	Vital Images Vitrea 2,Version 2.1
510(k) number		K002519
Intended use	Intended for the display and 3Dvisualization of medical imagedata derived from CT and MRIscans. It is intended to be usedby qualified and trained medialprofessionals, after properinstallation.	Intended for processing /analyzing 2D/3D images fromCT / MR scanners.
Type of software program	Stand alone applicationprogram	Stand alone applicationprogram
Software platformrequired	Windows NT, Windows 2000professional	Windows NT
Stereoscopic Interactiveconsole	Dextroscope or DextroBeam	None
Medical Image Modalities
All DICOM 3.0recognized modalitieswhere datasets arecomprised of parallel,2D images with knowinter-image spacing	Yes	Yes
Measurements
Distance	Yes	Yes
Area	No	Yes
Volume	Yes	Yes
Interactive contourdefinition of lesions	Yes (Contour Editor)	No
Safety: Clinicianreview/editing of data	Yes (distance and volumemeasurements are displayed,can be modified and beaccepted or rejected byclinician)	Yes (clinician interactivereviews and edits the data)
Data Source	CT/MR scanners	CT/MR scanners
Stereoscopic view	Yes	No
Dextroscope Technology(direct hand access of 3Dobjects using 3D joystickand 3D stylus)	Yes	No

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Image Processing System

Volume Interactions Pte Ltd

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Discussion of similarities and differences

The software module VizDexter™ 2.0 of the Volume Interactions Image Processing System utilizes similar technological characteristics as the predicate devices. All provide multiview user interfaces with combinations of 2D and 3D views correlated together for enhanced visualization. All provide measurement tools for analysis of the observed structures (volumes); and allow virtual lighting parameters to emphasize details.

VizDexter™ 2.0 and all predicates, provide 3D views. As with Vitrea 2 and Voxar Plug n View 3D, VizDexter 2.0 utilizes direct volume rendering for all its 3D views, including transparent volume images and visible surface views. For changing the mapping to opacity during translucent views, VizDexter 2.0 is similar to Voxar Plug n View 3D and Vitrea 2.

VizDexter™ 2.0 has functions of multi-modal volume rendering and a registration facility, which are not present in Plug n View 3D and Vitrea 2.

Volume Interactions Image Processing System and all predicates use identical technology to manipulate and display the 2D image views of the data sets (industry standard mouse and keyboard and a computer monitor). VizDexter™ 2.0 differs from all predicates however in the user interface utilized to manipulate the 3D image data, and in the display of the 3D image data. The user interfaces of the Dextroscope and the DextroBeam utilize an industry standard 3D tracker to position and orient the 3D image data with both hands, for ease of manipulation. The display of the 3D data is achieved by wearing stereoscopic glasses to view the 3D images of a computer monitor through a normal mirror (Dextroscope ™) or to view the 3D images displayed by a stereoscopic projector (DextroBeam ™). Voxar Plug n View 3D and Vital Images Vitrea 2.0 do not provide stereoscopic display nor hand controlled 3D trackers and follow the conventional keyboard and mouse interface for 2D and 3D interactions.

Technological characteristics

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.

Conclusion

We conclude that the Volume Interactions Image Processing System (VizDexter™ 2.0, Dextroscope™ and DextroBeam ™) is substantially equivalent to its predicate devices in its ability to render 3D images for use in medical analysis. In comparison of the predicate devices Volume Interactions Image Procession System provides a user interface that utilizes both hands to manipulate the 3D image data, and a stereoscopic display to view the 3D image data, which the predicate devices do not provide.

Regarding safety and effectiveness, Volume Interactions Pte Ltd is an ISO 9001;2000 certified company. All processes are controlled and monitored. Risk management including risk analysis, verification and validation tests. and evaluation by hospitals control potential hazards in both software and hardware. The level of concern for the Volume Interactions Image Processing System is minor.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 25 2002

Mr. John Baby Process Development Manager Volume Interactions, Pte., Ltd. 5 Shenton Way #37-04 UIC Building 068808 SINGAPORE

Re: K022938

Trade/Device Name: VizDexter Version 2.0; Dextroscope MK8; Dextrobeam MK3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ

Dated: August 30, 2002 Received: September 4, 2002

Dear Mr. Baby:

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 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); 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.

Image /page/7/Picture/12 description: The image shows a partial view of a logo or seal, focusing on the upper left quadrant. A portion of the text "DEPARTMENT OF..." is visible, arranged vertically along the left edge. To the right of the text, there are three stylized, curved lines that appear to be a design element of the logo. The overall impression is that the image captures a fragment of an official emblem or seal.

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This letter will allow you to begin marketing your device as described in your 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Snogdon

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 2.

510(k) Number: Ko 2 2938

Device Name:

lmage Processing System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Oerist A. Seymour

(Division Sign-Off) Division of Reproductive, Abdomina anc Padiological Devices 5 ! (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).