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

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 PC compatible computers and hardware components with the Microsoft Windows NT and 2000 operating systems.

The system consists of three product modules namely, RadioDexter™, Dextroscope™ and Dextrobeam™. The modules are described as follows:

RadioDexter™ 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 uses various user selectable industry standard rendering methods and algorithms.

DTI (Diffusion Tensor Imaging) is an add-on module to RadioDexter™. This module allows the user to visualize white matter anatomy in the form of fiber tracks. The intended use of this module is to generate and provide a visual reference of white matter fiber tracks in a 3D virtual reality environment during the process of neurosurgery planning using the Dextroscope™ or during a discussion/collaboration using the Dextrobeam™. It is not intended to be used otherwise.

Dextroscope™ is an interactive console and display system that allows the user to interact with two hands with the 3D images generated by the RadioDexter™ 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 submission describes an "Image Processing System" (RadioDexter™, Dextroscope™, and Dextrobeam™) by Volume Interactions Pte Ltd. This device is for the display and visualization of 3D medical image data from tomographic radiology images. The submission pertains to a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than on presenting results from specific clinical trials or studies designed to meet detailed acceptance criteria.

Therefore, the document does not contain information typically found in a study demonstrating how a device meets acceptance criteria, such as:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods for test sets.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone (algorithm-only) performance results.
Details on the type of ground truth used or the sample size and establishment of ground truth for a training set in a way that would be typical for an AI/ML medical device submission proving performance against acceptance criteria.

The submission is for a device categorized as an "Image Processing System" and "Picture Archiving and Communications System (PACS)." The focus here is on ensuring the device's functionality and safety and technological equivalence to a predicate device, as opposed to demonstrating specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC) that are common for AI/ML-driven diagnostic aids.

Based on the provided text, the following can be extracted and inferred:

Acceptance Criteria and Reported Device Performance:

The submission does not explicitly define acceptance criteria as performance metrics (e.g., sensitivity, specificity, accuracy) would be for an AI/ML diagnostic device.
The "acceptance criteria" in this context are implicitly understood as demonstrating substantial equivalence to the predicate device (K063730).
The device's reported "performance" is that it "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." It also allows users to "spatially manipulate, process to highlight structures and volumes of interest, and measure distances and volumes."
The DTI add-on module's performance is to "visualize white matter anatomy in the form of fiber tracks" and "generate and provide a visual reference of white matter fiber tracks."

Table of Acceptance Criteria and Reported Device Performance (Inferred from Substantial Equivalence):

Acceptance Criterion (Inferred from Substantial Equivalence)	Reported Device Performance
Use same operating principle as predicate device.	Device reads and displays 3D medical image data.
Have same technological characteristics as predicate device.	Device uses various user-selectable industry standard rendering methods and algorithms; runs on commercially available PC compatible computers with Microsoft Windows NT and 2000.
Incorporate similar basic software and hardware design.	System comprises RadioDexter™, Dextroscope™, and Dextrobeam™. Hardware uses industry standard components.
Have same fundamental scientific technology.	(Identical to predicate)
DTI module safety and effectiveness.	DTI module "has been verified and validated according to Volume Interactions' procedures for product design and development. The validation proves the safety and effectiveness of the module." (No specific performance metrics are given for "safety and effectiveness" in the document).

Sample size used for the test set and the data provenance:
- The document does not detail specific "test sets" or their sample sizes as would be typical for performance evaluation of a new algorithm. The validation mentioned for the DTI module likely involved internal testing procedures rather than a large clinical test set.
- Data provenance (country of origin, retrospective/prospective) is not mentioned. The device reads DICOM 3.0 format medical image data, implying it processes medical images from various sources, but the origin of data used for any internal verification/validation is not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The nature of the device (image processing and visualization) means "ground truth" might refer to the accuracy of 3D reconstructions or measurements, rather than diagnostic labels.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not provided.
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:
- This type of study was not mentioned. The device is an image processing and visualization system, not an AI-driven diagnostic aid that would typically undergo such a comparative effectiveness study to measure reader improvement. The DTI module "provides a visual reference" for planning, implying it's a tool for visualization, not a standalone diagnostic interpretation by AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the DTI module provides "visual reference" for human professionals ("intended to be used by qualified and trained medical professionals"). It describes functionality ("generate and provide a visual reference") rather than a standalone diagnostic performance metric. Thus, no standalone performance evaluation in the typical sense of a diagnostic algorithm is mentioned.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided in detail. For an image processing system, ground truth might relate to the accuracy of the 3D reconstructions against the original slice data, or the accuracy of measurements compared to known physical dimensions, or the anatomical correctness of fiber tracks as verified by neuroanatomists. The document only states the DTI validation "proves the safety and effectiveness of the module."
The sample size for the training set:
- This information is not provided. The document predates the widespread regulatory focus on AI/ML training data sets. The DTI module would likely have been developed and "trained" or optimized with a set of DTI images, but no details are given.
How the ground truth for the training set was established:
- This information is not provided.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Volume Interactions Bracco Group. The logo is black and white. The word "Volume" is in large, bold letters, with a hand pointing to the "o" in Volume, which is a sphere made of dots. Below Volume is the word "INTERACTIONS" in smaller, bold letters, and below that is "Bracco Group" in a smaller, non-bold font.

Tuvalu

K07/1054

510(k) Summary Of Safety and Effectiveness		MAY 22 2007
RadioDexter™™, Dextroscope™ and Dextrobeam™™
Submitter Information
Manufacturer:	Volume Interactions Pte Ltd1 Kim Seng Promenade #12-01Great World City East TowerSingapore 237994Phone: + 65 62226962 ext 232Facsimile: + 65 62226215
Contact Person:	Michael Sim, Director, Worldwide Operations
Summary Date:	9th April 2007
Device NameCommon Name:	Image Processing System
Trade Name:& Model No.	RadioDexter™™ 1.0, Dextroscope™™ MK10, Dextrobeam™ MK3 &MK4
Classification Name:	Picture Archiving and Communications System (per 21 CFR892.2050)
Classification Number:	LLZ

Intended Use

Predicate device

Trade Name & Model No.:	RadioDexter™ 1.0, Dextroscope™ MK10,Dextrobeam™ MK3 & MK4
510(k) number:	K063730

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Image /page/1/Picture/0 description: The image shows the logo for Volume Interactions, a Bracco Group company. The logo features the word "Volume" in a bold, sans-serif font, with a graphic of a hand touching a dotted sphere in place of the "o". Below "Volume", the word "INTERACTIONS" is written in a smaller, sans-serif font. Underneath "INTERACTIONS" is the text "Bracco Group".

Device Description

The system consists of three product modules namely, RadioDexter™, Dextroscope™ and Dextrobeam™. The modules are described as follows:

DTI (Diffusion Tensor Imaging)

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Image /page/2/Picture/0 description: The image shows a logo for Volume Interactions, a Bracco Group company. The logo features the word "Volume" in bold, with a hand pointing towards a sphere made of interconnected lines. Below "Volume" is the word "INTERACTIONS" in a smaller, sans-serif font, and below that is "Bracco Group" in a similar font.

Substantial Equivalence

The Image Processing System in this submission remains unchanged as previously received 510(k)063730, in the following aspects:

Use the same operating principle .
Have the same technological characteristics .
Incorporate similar basic software and hardware design .
Have the same fundamental scientific technology .

The only differences are as follows:

Intended Use

The following statement has been removed from the intended use:

"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."

The device's input is derived from tomographic radiology images and the data format of the input is in either DICOM 3.0 or other common imaging formats (classic SGI formats. TIFF, Raw volume chunk or slices). It is clear that the input is not derived from patients directly which is why our company finds it redundant to highlight that there is no direct patient contact and connection to equipment that is used in direct contact with the patient. Removal of the statement does not affect the safety and effectiveness of the device as this does not change the system in terms of performance, design and technological characteristics.

DTI (Diffusion Tensor Imaging)

DTI has been verified and validated according to Volume Interactions' procedures for product design and development. The validation proves the safety and effectiveness of the module.

Conclusion

In summary, the Image Processing System (Dextroscope™, Dextrobeam™ with RadioDexter™ ) described in this submission are, in our opinion, substantially equivalent to the predicate device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Michael Sim Director, Worldwide Operations Volume Interactions Pte Ltd 1 Kim Seng Promenade #12-01 Great World City East Tower SINGAPORE 237994

MAY 2 2 2007

Re: K071054

Trade/Device Name: Image Processing System (Dextroscope™ MK10. Dextrobeam™ MK3 and MK4, and RadioDexter™ 1.0) Regulation Number: 21 CFR §892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 9, 2007 Received: April 16, 2007

Dear Mr. Sim:

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 (Premarket Approval), 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.

Image /page/3/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo, with the word "Centennial" underneath. The text "FDA Centennial" is in a stylized font. The text "Health is Confidence Protected" is around the perimeter of the logo.

Protecting and Promoting Public Health

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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 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address

http://www.fda.gov/cdrh/industry/support/index.html

Sincerely yours,

Nancy C. Brogdon

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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INDICATION FOR USE STATEMENT

510(k) Number

KD71054

Image Processing (Dextroscope™ MK10, Device Name System . . Dextrobeam™ MK3 and MK4, RadioDexter™ 1.0)

Indication for Use

Over-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Per 21CFR 801 Subpart D) .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancyc brogdon
(Division Sign Off)

(Division Sign-Off Division of Reproductive, Abdominal, a 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).