The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.

The 3Dnet Suite provides several levels of functionality to the user:

basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP, MinIP, measurements, annotations, reporting, distribution etc.
tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc.
Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, targeted measurement and visualization, including colon screening which is indented for the screening of patients for colonic polyps, tumors and other lesions using tomographic colonography.

Device Description

The 3Dnet Suite is a software device for evaluating scanned images of selected human organ. The basic visualization module of 3Dnet Suite is Examiner.

The Examiner allows the processing, review, analysis, communication and media interchange of multi dimensional digital images acquired from a variety of imaging devices.

It provides multi-dimensional visualization of digital images to aid clinicians in their analysis of anatomy and pathology. The 3Dnet user interface follows typical clinical workflow patterns to process, review and analyze digital images including:

Retrieve image data over the network via DICOM
Select images for closer examination from a gallery of 2D and 3D views
Interactively manipulate an image in real time to visualize anatomy and pathology
Annotate, tag, measure and record selected views
Output selected views to DICOM and JPEG files or expert views to another DICOM device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the 3Dnet Suite device:

Acceptance Criteria and Device Performance for 3Dnet Suite

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for the 3Dnet Suite, a medical image processing software system. As such, the "acceptance criteria" are primarily established through a comparison of functionalities and a demonstration that the new device performs those functions equivalently and safely. Formal, quantitative performance metrics with specific thresholds (like accuracy, sensitivity, specificity percentages) are not explicitly stated as distinct acceptance criteria that the device must meet in a numerical sense. Instead, the acceptance criteria are implicitly met by:

Matching/exceeding functionalities of predicate devices.
Demonstrating accurate processing and visualization of medical images.
Ensuring the software operates reliably and consistently.
Adhering to software development standards.

The study described is a non-clinical test performed for the determination of substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (from "Discussion of non-clinical tests")
Functional Equivalence: Display 2D/3D visualization of DICOM compliant medical image data (CT, MRI, Ultrasound).	The application provided interactive orthogonal and multiplanar reformatted 2D and 3D image from datasets to detect and evaluate known abnormalities or status of organs.
Accurate Measurement & Analysis: Provide measurement tools (volume, linear, angular) for analysis of observed structures.	The volume, linear and angular measurements features, provided in the software, were used to evaluate and quantify any abnormality of organs or status of any internal organ structures. Accuracy correlated "perfectly" with pre-calculated values for phantom datasets.
Reliability & Usability: Operate reliably, be easy to use, and capable of evaluating DICOM compliant scanned images.	The product has shown itself to be reliable, easy to use and capable of evaluating DICOM compliant scanned images of any human organs.
Software Quality: Developed consistent with accepted standards for software development.	The 3Dnet Suite has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols.
DICOM Conformance: Validate DICOM functionality with other compliant applications and tools.	The DICOM functionality with regards to DICOM SOP classes as stated in the DICOM conformance statement was validated with a number of other DICOM compliant applications and DICOM validation tools as part of the development and testing process.
Safety & Effectiveness: Pose no new questions of safety or effectiveness compared to predicate devices.	"We conclude from these tests that 3Dnet Suite is substantially equivalent to the predicated devices in its ability to evaluate any human organs." and "3Dnet Suite does not raise any new questions of safety or effectiveness."

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

Sample Size: "Scanned image datasets of various patient organs with known abnormalities or status" and "phantom datasets." The exact number of patient datasets or phantom datasets is not specified in the provided text.
Data Provenance:
- Patient Data: "Patients Image Data in our installations in Europe." This indicates a European origin. The text does not explicitly state if this data was retrospective or prospective, but the phrasing "known abnormalities or status" suggests it was existing, retrospective data used for testing.
- Phantom Data: Origin not specified, but likely internally generated or standard phantoms.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth on the patient or phantom datasets. It refers to "known abnormalities or status" for patient data and "pre-calculated values" for phantom data, implying an established ground truth, but the method of establishment or the experts involved are not detailed.

4. Adjudication Method for the Test Set

The document does not specify any formal adjudication method (e.g., 2+1, 3+1). The testing appears to be an internal verification process against "known" or "pre-calculated" ground truth.

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

No, a MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through functional comparison and non-clinical testing, not a comparative study with human readers with and without AI assistance.

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

Yes, a standalone study was done. The "discussion of non-clinical tests" describes the device's performance against "known abnormalities or status" and "pre-calculated values" using phantom and patient datasets without mention of human interaction in the direct performance evaluation. The device is designed for physicians to use, but the testing described here evaluates the software's inherent ability to process, visualize, and measure.

7. The Type of Ground Truth Used

For Patient Data: "Known abnormalities or status" (e.g., presence, location, and characteristics of polyps, tumors, or other lesions). This implies a clinical ground truth likely established by expert interpretation or, potentially, pathology/surgical findings, though not explicitly stated.
For Phantom Data: "Pre-calculated values." This is an objective, engineered ground truth based on the design specifications of the phantom.

8. The Sample Size for the Training Set

The document does not mention a training set or its sample size. This device is described as an "Image processing system" or "Medical Image Processing software system" which provides visualization and analysis tools. There is no indication that it employs machine learning or AI that would require a distinct training set in the modern sense. The "development" and "testing process" mentioned relate to software engineering principles rather than AI model training.

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

As no training set is mentioned for an AI/ML context, this question is not applicable. The software development process mentioned involves "unit and system integration testing protocols," which use "known abnormalities or status" (for patient data) and "pre-calculated values" (for phantom data) as verification and validation ground truth.

Summary

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OCT 2 7 2006

Medicine in Three Dimensions

510(k) SUMMARY

This summary of 510(k) safety and efficiency information is been submitted in accordance with the requirements of SMDA 1990 and 21 CFR $807.92.

The assigned 510(k) number is ........................

1. Submitter's identification:

Biotronics3D Ltd. 31 Ferry Street Isle of Dogs Docklands London E14 3DT UK

Contact: Dr Haralambos Hatzakis, Managing Director.

Date Summary prepared: 15 May 2006.

2. Name of Device

a) Device trade name: 3Dnet Suite.
b) Device common name: Medical Image Processing software system.
c) Classification name: LLZ Image processing system Class II, CFR 21 892.2050.

3. Predicate Device Information:

Predicate Device #1: Bio-Vascular, Inc., Advanced Diagnostic Viewer (ADV), 510(k) #K963697

Predicate Device #2 : Voxar Limited, Plug n View, version 1.0, 510(k) #K992654

4. Device Description :

The 3Dnet Suite is a software device for evaluating scanned images of selected human organ. The basic visualization module of 3Dnet Suite is Examiner.

The Examiner allows the processing, review, analysis, communication and media interchange of multi dimensional digital images acquired from a variety of imaging devices.

Retrieve image data over the network via DICOM ﮯ
Select images for closer examination from a gallery of 2D and 3D views -
-Interactively manipulate an image in real time to visualize anatomy and pathology
Annotate, tag, measure and record selected views -

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Output selected views to DICOM and JPEG files or expert views to another DICOM device.

5. Indications for use:

The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.

The 3Dnet Suite provides several levels of functionality to the user:

basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP. MinIP, measurements, annotations, reporting, distribution etc.
tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, = grayscale VR slab. 3D volume review, path definition and boundary detection etc.
Specialist tools and workflow enhancements for specific clinical applications which provide target workflows, custom UI, targeted measurement and visualization, including colon screening which is indented for the screening of patients for colonic polyps, tumors and other lesions using tomographic colonography.

6. Comparison to predicate devices:

The 3Dnet Suite utilizes the same technological characteristics as the two predicate devices. All provide multi-view user interfaces with combinations of 2D and 3D views correlated together for enhanced visualization. All provide window/level adjustment of the 2D and 3D views to enhance features, provide measurement tools for analysis of the observed structures, provide region of interest tools to isolate specific features and provide annotation tools to help indicate and describe findings.

All devices support the DICOM protocol for the communication of images with other medical devices.

Company	Biotronics3D	Voxar Limited	Bio-Vascular, Inc.
System	3Dnet Suite	Plug n View, version1.0	Advanced DiagnosticViewer (ADV)
510(k) no:		K992654	K963697
Function:	• 2D/3D image viewing• Segmentation• Measurements• Data Analysis• Multi-Planarreformatting (MPR)	• 2D imageviewing• Measurement• Multi-Planarreformatting(MPR)	• Display• Segmentation• ManualMeasurements• Data analysis• Archive

Substantial Equivalence Comparison Chart

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	Volume rendering Maximum Intensity Projection (MIP) Image Editing Printing	Volume rendering Maximum Intensity Projection (MIP) Image Editing Printing
Intended Use:	Display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.	Display and 3D visualization of medical image data derived from CT and MRI scans.	Create 2D,3D images of the anatomy for clinician viewing analysis
Data Source:	MR,CT,3D US scanners	MR, CT, NM, CR, and US Scanners	MR, CT Scanners
Physical Characterization:	Software package Operates on off the self hardware Windows operating system DICOM compatible	Software package Operates on off the self hardware Windows operating system DICOM compatible	Software package Operates on off the self hardware Windows operating system DICOM compatible

We conclude that the subject device, the 3Dnet Suite, is as safe and effective as the predicate devices and poses no new questions of safety and effectiveness.

7. Discussion of non-clinical tests performed for the determination of substantial equivalence are as follows:

Scanned image datasets of various patient organs with known abnormalities or status used as input for testing of software functionalities in accordance with a test protocol. The application provided interactive orthogonal and multiplanar reformatted 2D and 3D image from datasets to detect and evaluate the known abnormalities or status of organs. The volume, linear and angular measurements features, provided in the software, were used to evaluate and quantify any abnormality of organs or status of any internal organ structures. The 3Dnet Suite has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols. Testing of phantom datasets has determined its level of accuracy, which correlates perfectly with pre-calculated values. The product has shown itself to be reliable, easy to use and capable of evaluating DICOM compliant scanned images of any human organs. We conclude from these tests that 3Dnet Suite is substantially equivalent to the predicated devices in its ability to evaluate any human organs.

1. Conclusions:

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Biotronics 3D

The 3Dnet Suite has the same indented use and similar technological characteristics as the Bio-Vascular, Inc., Advanced Diagnostic Viewer (ADV), (#K963697) and Voxar Limited, Plug n View 3D, version 1.0 (#K992654). Moreover, test and validations using Patients Image Data in our installations in Europe and non-clinical tests performed in-house demonstrated that the 3Dnet Suite is substantially equivalent to the predicate devices in its ability to review, and evaluate DICOM scan images of various organs to facilitate analysis and evaluation of abnormality or malformation in organs by a trained user. The DICOM functionality with regards to DICOM SOP classes as stated in the DICOM conformance statement was validated with a number of other DICOM compliant applications and DICOM validation tools as part of the development and testing process. 3Dnet Suite does not raise any new questions of safety or effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and is oriented to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

OCT 2 7 2006

Biotronics 3D. Ltd. % Ms. Patricia L. Murphy Official Correspondent KEMA Quality B.V. 4377 County Line Road CHALFONT PA 18914

Re: K063107

Trade/Device Name: 3Dnet Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 4, 2006 Received: October 11, 2006

Dear Ms. Murphy:

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 commerco 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, Or Lovecs and 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. TToe general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulter vi on.

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 affective 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/4/Picture/10 description: The image is a circular logo or seal. The text "1906-2006" is at the top of the circle. The letters "FDA" are in the center of the circle. The word "Centennial" is below the letters. Three stars are below the word "Centennial".

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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy Cbrogdon

Nancy C. Brogdon Director, Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2 -

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Indications for Use

510(k) Number (if known):

Device Name: 3Dnet Suite

Indications For Use:

The 3Dnet Suite is intended to be used by physicians for the display of 2D/3D visualization of DICOM compliant medical image data, such as CT, MRI, and Ultrasound scans.

The 3Dnet Suite provides several levels of functionality to the user:

basic analysis tools they use on a daily basis such as 2D review, orthogonal multiplanar reconstructions (MPR), oblique MPR, curved MPR, Slab MPR AvgIP, MIP, MinIP, measurements, annotations, reporting, distribution etc.
tools for in-depth analysis, such as segmentation, endoscopic review, color VR slab, grayscale VR slab, 3D volume review, path definition and boundary detection etc.
Specialist tools and workflow enhancements for specific clinical applications ﺖ which provide target workflows, custom U1, measurement and visualization. including colon screening which is indented for the reviewing of patients for colonic polyps, tumors and other lesions using tomographic colonography.

Prescription Use X (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Seaman

(Division Sign-Off) Page 1 of 1 Division of Reproductive, Abdomin 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).