The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of patient screening for detection of colon cancers, polyps, masses, and other lesions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cecum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the entire colon, and also includes a reporting facility to enhance workflow for patient screening. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive print and distribute colon image studies utilizing PC hardware.

Device Description

The Viatronix V3D Colon contains all of the required hardware and software components to provide interactive 3D and 2D views of diagnostic CT and MR scan images of the colon. The views include both inner and outer surface 3D volume rendered images as well as orthogonal and multiplaner reformatted 2D images. This ability to view the dataset in different perspectives from which it was acquired is performed by first transferring DICOM images from the MR or CT scanners to the Viatronix V3D Colon, which automatically identifies regions of interest and displays thesc regions to the user in the above mentioned views. The user can then navigate freely within the dataset/region of interest or follow automatically computed paths to fly through the colon or around the outside of the colon structure. Measurements of the size of colon polyps, masses or lesion can be made for patient screening and for planning treatment.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Viatronix V3D Colon, revision 1.3, based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Preamble Goals
Accurate 3D model of the entire colon is generated	Verified
Fly-through in the 3D model for the entire colon is possible	Verified
Viewing 2D and MPR images of the entire colon is possible	Verified
Measurements are accurate (using phantom)	Verified
Ability to fly through and visualize the entire colon	Demonstrated
Ability to visualize and measure polyps, masses and lesions for patient screening to detect colon cancers	Demonstrated
Clinical Study Performance (Colorectal Neoplasia Screening in Asymptomatic Adults)
Virtual Colonoscopy (VC) Sensitivity for 10mm adenomatous polyps	93.8%
Virtual Colonoscopy (VC) Sensitivity for 8mm adenomatous polyps	93.9%
Virtual Colonoscopy (VC) Sensitivity for 6mm adenomatous polyps	88.7%
Virtual Colonoscopy (VC) Specificity for 10mm adenomatous polyps	96.0%
Virtual Colonoscopy (VC) Specificity for 8mm adenomatous polyps	92.2%
Virtual Colonoscopy (VC) Specificity for 6mm adenomatous polyps	79.6%
Detection of malignant polyps (2 total)	Both detected on VC

Note on Acceptance Criteria: The document primarily lists "goals of clinical testing" rather than explicit numerical acceptance criteria for all aspects. For sensitivity and specificity, the reported values can be considered the demonstrated performance against assumed implicit acceptance thresholds for a diagnostic tool in this context.

Study Details

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

Sample Size: A total of 1233 asymptomatic adults.
Data Provenance: US Government's Department of Defense Medical Centers (United States). The study was prospective, as it involved subjects undergoing both virtual colonoscopy and optical colonoscopy on the same day.

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

The document implies that the "Results" section of the major clinical study (8.1) references data where Optical Colonoscopy (OC) served as a comparator for sensitivity and specificity. However, it does not explicitly state the number of experts who established the ground truth from OC, or their qualifications.
For the "Initial Clinical tests" (8.2), a single radiologist reviewed the clinical data.
- Qualifications of Radiologist (8.2): Experienced with predicate devices.

3. Adjudication Method for the Test Set:

For the main clinical study (8.1), the document mentions a comparison with optical colonoscopy. One paragraph states: "Two polyps were malignant; both were detected on VC and one was missed on OC before the results on VC were revealed." This implies a potential sequential or blinded review process where OC findings were known post-VC review, but a formal adjudication method (like 2+1) is not explicitly detailed.
For the "Initial Clinical tests" (8.2), the review was performed by a single radiologist, suggesting no formal adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

No, a formal MRMC comparative effectiveness study aiming to measure the effect size of human readers with vs. without AI assistance is not described.
The main clinical study (8.1) compares the device's performance (VC) directly against Optical Colonoscopy (OC) in terms of sensitivity and specificity, effectively comparing the AI-assisted diagnostic pipeline (VC reviewed by an unnamed number of readers) to the gold standard (OC). It does not isolate the improvement from AI assistance to a human reader.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No, the studies described do not appear to be standalone algorithm-only performance evaluations.
The device is a "system for the display and visualization" intended for use by "Radiologists, Clinicians and referring Physicians." The clinical study evaluated "Virtual Colonoscopy (VC) ... by patient," which implicitly involves human interpretation of the V3D Colon output. The "Initial Clinical tests" section explicitly states that a radiologist reviewed the rendering.

6. The Type of Ground Truth Used:

For the main clinical study (8.1): Optical Colonoscopy (OC) findings were used as the primary ground truth. This is a form of clinical/procedural ground truth.
For the non-clinical tests (7): Phantoms with structures of known size and distance were used. This is a form of physical phantom ground truth.

7. The Sample Size for the Training Set:

The document does not specify a sample size for the training set. It discusses the development process ("developed in a manner consistent with accepted standards for software development, including test protocols") and testing, but not the data used to train the AI/algorithm component of the system.

8. How the Ground Truth for the Training Set was Established:

The document does not provide information on how ground truth was established for any training set, as a training set is not explicitly discussed.

Summary

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APR 1 9 2004

EXHIBT #1 5 pages

510(K) SUMMARY

This summary of 510(k) safety and effective4ness information is being submitted in accordance with the requirements of SMDA 0990 and 21 CFR § 807.92.

The assigned 510(k) number is: K040126

Submitter's Identification 1.

Viatronix, Inc. 25 East Loop Road Suite 204 Stony Brook, NY 11790 Establishment Registration # 2438935 Contact: Michael Meissner

Date Summary Prepared:

January 15, 2004

2. Name of Device:

Viatronix V3D Colon, revision 1.3

3. Predicate Device Information:

G.E. Navigator, 510(k) # K954355. This system is an add-on to the Advantage ત્વ. Windows Workstation. Many features in the manual reference the base workstation manuals. Therefore, some of the following references are to the Advantage Windows Manuals. (892.1000, Product Code LNH)
b. Siemens Realtime 3D Diagnostic Workstation, 510(k) # K973010. The trade name of this device is 3D Virtuoso. (892.2050, Product Code: 90LLZ)

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Voxar VC Model 1.0, 510(k) # K012072. The trade name of this device is Voxar C. Colonscreen. (892.2050, Product Code: 90LLZ)
Vital Images Vitrea 2, Version 2.1, 510(k) # K002519. (892.2050, Product Code: dl. 90LLZ)
Viatronix Visualization System, 510(k) # K002780. This system name is e. sometimes abbreviated as VVS. (892.2050, Product Code: 90LLZ)

4. Device Description:

ડ. Intended Use:

The Viatronix V3D Colon is a system for the display and visualization of 3D and 2D medical image data of the colon derived from DICOM 3.0 compliant CT and MR scans, for the purpose of patient screening for detection of colon cancers, polyps, masses and other Icsions. It provides functionality for display, measurement and electronic cleansing to assure complete visualization of the colon from rectum to cccum and vice versa for both prone and supine views. It generates a centerline for guided interactive navigation and fly through of the cntire colon, and also includes a reporting facility to enhance workflow for patient screening. It is intended for use by Radiologists, Clinicians and referring Physicians to process, render, review, archive, print and distribute colon image studies utilizing PC hardware.

6. Comparison to Predicate Devices:

The Viatronix V3D Colon Module (V3D Colon) utilizes the same technological characteristics as the five predicate devices. All provide multi-view user interfaces with combinations of 2D and 3D views correlated together for enhanced visualization. All provide measurement tools fro analysis of the observed structures; allow adjustment to virtual lighting parameters to emphasize

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details, and provide window/level adjustment of the 2D Views to cnhance features.

V3D Colon and all five predicates, provide external 3D views. Only G.E. Navigator, 3D Virtuoso, Vitrca 2, and VVS provide endolunimal 3D views. As with Vitrea 2, Voxar VC, and VVS, the V3D Colon Module utilizes direct volume rendering for all of its 3D views, including transparent volume images and visible surface views. While 3D Virtuoso provides volume rendered images, in some cases there is initial surface extraction. G.E. Navigator utilizes surface extraction techniques for all 3D views. For changing the mapping to opacity during translucent views, V3D Colon is similar to Siemens 3D Virtuoso, Voxar VC. Vitrea 2. and VVS devices because all use the same technique of volume rendering.

With V3D Colon, the user may choose between automatic path planning or interactive flight control. The G.E. Navigator also automatically plans a path, but requires the user to build the path in many short segments by pressing a button for each step. In essence, the V3D Colon Module performs the Navigator "auto step and align" function multiple times until the end of the organ is found. Vital Images Vitrea 2 allow the user to move forward by dragging the mouse forward keeping the viewpoint within the hollow of the organ by bouncing off the walls. VVS and V3D Colon also restrict the view to the hollow of the organ by bouncing off the walls in a similar way.

Siemens 3D Virtuoso performs semi-automatic segmentation by calculating each step of the segmentation process, allowing the user to view the results and then interactively adjust any incorrect features. The V3D Colon Module is similar, but performs the complete segmentation before requiring the user to interact with the system to adjust the results.

G.E. Navigator, Voxar VC, VVS, and V3D Colon are specifically designed to streamline the typical colon examination. They provide the ability to load both supine and prone datasets at the same time. Thy also allow the setting of landmarks (points of interest), reviewing these in an organized fashion, and the entering of comments specific to each landmark.

We conclude that the subject device, the Viatronix V3D Colon, is as safe and effective as its predicate devices and poses no new questions of safety and effectiveness.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence is as follows:

Testing was conducted using phantoms with structures of a known size and distance from the start inserted into the phantom. The person using the system did not have advance knowledge as to the number of structures nor their size and

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location. An indcpendent reviewer then compared the test results with the actual phantoms and made an assessment as to accuracy.

The Viatronix V3D Colon has been developed in a manner consistent with accepted standards for software development, including test protocols. Testing on phantom objects has determined its level of accuracy; which is substantially equivalent to that of its predicate devices. The product has shown itself to be reliable, easy to use and capable of rendering useful 3D medical images.

Discussion on Clinical Tests/Evaluations Performed 8.0

8.1 Clinical study to screen for Colorectal Neoplasia in Asymptomatic Adults

An independent clinical study was performed using Viatronix V3D Colon to screen for Colorectal Neoplasia in Asymptomatic adults at US Government's Department of Defense Medical Centers. This independent study was funded by the US Government. A total of 1233 asymptomatic adults underwent same day virtual colonoscopy using V3D Colon and optical colonoscopy. The Sensitivity and specificity of Virtual Colonoscopy (VC) and the sensitivity of Optical Colonoscopy (OC) were calculated. The study report is published in the New England Journal of Medicinc on December 4, 2003, VOL. 349, NO 23. A copy of this study report is Attached in exhibit # 5.

Results: Virtual Colonoscopy (VC) sensitivity by patient for adenomatous polyps was 93.8% , 93.9%, and 88.7% for size thresholds of 10, 8, and 6 mm, respectively. At the same polyp size thresholds, Optical Colonoscopy (OC) sensitivity by patient for adenomatous polyps was 87.5%, 91.5%, and 92.3%, respectively. VC specificity by patient for adenomatous polyps of same threshold sizes was 96.0% , 92.2% and 79.6% respectively. Two polyps were malignant; hoth were detected on VC and one was missed on OC before the results onVC were revealed.

Conclusions: CT virtual colonoscopy with a 3D emphasis is an accurate screening mcthod for detection of colorectal neoplasia in asymptomatic averagerisk adults and compares favorably with optical colonoscopy in terms of the detection of clinically relevant lesions.

8.2 Initial Clinical tests :

Clinical tests on patients were done to verify that the system performs as intended with a broad sampling of input data. Each patient was assessed as to whether the core functionality of the Viatronix V3D Colon permitted fly through and visualization. Comparisons were made with optical endoscopy to give a qualitative judgment as to its ability to visualize structures. Comparisons to its predicate devices were also made as to its quality and effectivencss. Results:

The Clinical data was reviewed by a radiologist who determined that the rendering was accurate and medically useful. The radiologist was experienced with the predicate devices and found it substantially equivalent in essential

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features with improvements in the speed of rendering and the ease of performing segmentation.

Conclusions:

We conclude from these tests that the Viatronix V3D Colon is substantially equivalent to its predicate devices in its ability to render 3 D images for use in medical diagnostics. In comparison to optical endoscopy, the Viatronix V3D Colon is able to visualize structures of similar size and shape.

Attached as Exhibit #5 is our "Clinical Test Plan" which details tests performed, includes sample test forms, includes completed test forms (raw data) and outlines apparatus employed for optical endoscopy, with the following documents attached:

System Clinical Test Results (Phantom Studies) .
System Clinical Test Results (Visualization of Polyps) .
System Clinical Test Results (Human Studies) .

Clinical studies were performed under IRB (Institutional Review Board) overview, which include Patient Consent Forms, in accordance with 12 CFR Part 52.

This document is included in Exhibit # 5.

In summary, we conclude that we met our goals of clinical testing as follows:

Verified that an accurate 3D model of the entire colon is generated 0
Verified that fly through in the 3D model for the entire colon is possible 마
Verified that viewing 2D and MPR images of the entire colon is possible 사
4 Using a phantom, verified that measurements are accurate
Demonstrated the ability to fly through and visualize the entire colon ()
Demonstrated the ability to visualize and measure polyps, masses and lesions for 4 patient screening to detect colon cancers

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 9 2004

Mr. Baman Pattanayak Regulatory Consultant Viatronix, Inc. 25 East Loop Road, Suite 204 STONY BROOK NY 11790

Re: K040126 Trade/Device Name: Viatronix V3D Colon, revision 1.3 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Codc: 90 LLZ Dated: January 15, 2004 Received: January 23, 2004

Dear Mr. Pattanayak:

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 cither 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.

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 linited 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 the 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" (21CFR Part 807.97) you may obtain. 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. Brydon.

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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Image /page/7/Picture/0 description: The image shows the word "VIATRONIX" in a bold, sans-serif font. The letters are black, and there is a small, stylized graphic above the "V" that resembles a grid or network. The word appears to be slightly distressed or aged, with some minor imperfections or wear on the letters.

25 East Loop Road Suite 201 Stony Brook, New York 11790 TELEPHONE: 1-866-887-4636 FAX: 631-444-9701

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Exhibit B

INDICATIONS FOR USE

10401228 510(k) Number (if known):

Device Name: Viatronix V3D Colon, revision 1.3

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)

Daniel A. Lynn

(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devices 040126 510(k) Number

Over-The-Counter Use (Optional Format 1-2-96)

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).