The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET and SPECT scans of the human body including any organ. The volume , linear and angular measurement functions are intended for the evaluation and quantification of turnor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant specified organ image studies, utilizing PC hardware.

Device Description

The V-3D Explorer is a software device for evaluating scanned images of selected human organ. It is an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780, dated November 17, 2000. It is a general software module, designed for use as a part of our V-3D visualization system core technology. The system consists of a V-3D processor and a V-3D viewer in two computer configuration or V-3D processor and V3D viewer in a stand alone one computer configuration. Upon receipt of a multi-slice CT or MR scan image for any selected organ in a DICOM format, the V-3D processor converts the DICOM image data into an internally recognized volume data format using our core software. technology. The V-3D viewer provides interactive orthogonal and multiplanar reformatted 2D and 3D images from the V-3D processor and user can evaluate these images for any abnormality or malformation in specified organs obtained from scanned images. The volume, linear and angular measurement features provided in the software for the evaluation and quantification of organ volume, linear measurements, angular location/displacement for hard and soft tissues as well as internal organ structures for polyp, lesion, mass, tumor, implants, fracture, aneurysms, stenoses etc. The software also supports interactive segmentation of any organ from removing certain structure from display for critical evaluation of selected part of organ. The intended user can use the software device to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant images of any organ, utilizing PC hardware.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Viatronix V3D Explorer:

Summary of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Functional Equivalence	The V3D Explorer software module provided interactive orthogonal and multiplanar reformatted 2D and 3D images from datasets to detect and evaluate known abnormalities or status of organs. The volume, linear, and angular measurement features were used to evaluate and quantify abnormalities or status of internal organ structures.
Accuracy (Phantom Datasets)	Testing on phantom datasets determined its level of accuracy, which correlates perfectly with pre-calculated values.
Reliability & Ease of Use	The product has shown itself to be reliable and easy to use.
DICOM 3.0 Compliance	Capable of evaluating DICOM 3.0 compliant scanned images of any human organs.
Clinical Equivalence (Patient Data)	Evaluation results of both the predicate device and the V3D Explorer device were the same, and no significant differences were detected in the results of evaluation when using scanned images of various patient organs with known abnormalities or status. It was established that the V3D Explorer application is substantially equivalent to the predicate devices in its ability to review, analyze, and evaluate CT/MR scan images to facilitate analysis and evaluation of abnormality or malformation.
Safety & Effectiveness	Concluded to be as safe and effective as the predicate devices and poses no new questions of safety and effectiveness.

Study Information:

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of cases or patients. The document vaguely mentions "various patients organs with known abnormalities or status" for non-clinical tests and "Patients' various organs" for clinical tests.
- Data Provenance: The data used for testing was "Scanned image datasets of various patients organs" and "Patients' scanned organs images." The country of origin is not specified, but it implies retrospective use of existing patient data.
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not specified. The document indicates that "known abnormalities or status" were used, implying a pre-established understanding of the pathologies in the patient data. It doesn't detail how this "known status" was determined for the purpose of the study, nor does it mention a specific number or qualification of experts establishing this ground truth for the test set itself.
Adjudication Method for the Test Set:
- Not explicitly described. The study compares the V3D Explorer against predicate devices, stating that "evaluation results of both predicate device and V3D Explorer device were same and no significant differences were detected." This implies a direct comparison rather than an adjudication process typically used to reconcile expert discrepancies for ground truth.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a formal MRMC comparative effectiveness study is not described. The study performed was a comparison of the device's functionality and output against predicate devices, not an evaluation of human reader performance with and without AI assistance.
- Effect Size: Not applicable, as no MRMC study was performed.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, the non-clinical and clinical tests described appear to be primarily standalone evaluations of the software's ability to process images and provide measurements and visualizations comparable to predicate devices. While the software is intended for use by radiologists and clinicians, the evaluation itself focuses on the software's output, not on how human users integrate the software's output into their diagnostic process or how their performance changes. The phrasing "evaluated various organs using the predicate device and recorded the results" and "evaluated all Patients' various organs using V3D Explorer application, and recorded the results" suggests an assessment of the device's output rather than human performance.
Type of Ground Truth Used:
- The ground truth referenced for the test set is "known abnormalities or status" within patient organ images. For phantom datasets, the ground truth was "pre-calculated values." This implies a combination of expert consensus/clinical diagnosis (for patient data) and empirical measurements (for phantom data). Pathology or outcomes data are not explicitly mentioned as ground truth sources.
Sample Size for the Training Set:
- Not specified. The document describes the V3D Explorer as "an additional image processing option added to our V-3D visualization system for which pre-market clearance was granted by the FDA vide K#002780." It mentions "core software technology" developed in a manner consistent with accepted software development standards and unit/system integration testing. It does not provide details on a specific "training set" in the context of machine learning, as this predates widespread deep learning applications for medical image analysis. The "training" likely refers to standard software development and testing practices rather than machine learning model training.
How Ground Truth for the Training Set Was Established:
- Given that the document describes software developed under standard engineering practices rather than a machine learning model, the concept of a "training set" with ground truth (as understood for AI/ML) is not directly applicable or discussed in the text. The "ground truth" for the software's development likely refers to functional requirements specifications, expected outputs, and successful execution of unit and integration tests against these specifications. For phantom data, "pre-calculated values" would serve as the ground truth.

Summary

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EXHIBIT #1 4 pages

510(K) SUMMARY

K022739

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: ____________________________

1. Submitter's Identification:

Viatronix Inc. 25 East Loop Road Suite 203/ 204 Stony Brook, NY 11790 Establishment Registration number- 2438935

Contact: Baman Pattanayak, Director of QA/RA

Date Summary Prepared:

August 05, 2002

2. Name of the Device:

a) Device trade name: Viatronix V3D Explorer, revision 1.0 b) Device common name: Medical Image processing software system c) Classification name: 90LLZ- Image Processing system

3. Predicate Device Information:

Predicate Device #1: G.E. Navigator, 510(k) # K954355. This system is an add-on to the Advantage Windows Workstation. Many features in the manual reference the base workstation manuals.

Predicate Device #2: Vital Images Vitrea 2, Version 2.1, 510(k) # K002519.

Predicate Device #3: Viatronix Visualization System, 510(k) # K002780. This system name is sometimes abbreviated as VVS.

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4. Device Description:

5. Indications for Use:

The Viatronix V3D Explorer is intended to be used for the display and 2D/3D visualization of medical image data derived from CT, MRI, PET and SPECT scans of the human body including any organ. The volume , linear and angular measurement functions are intended for the evaluation and quantification of tumor or selected organ volume/linear measurements, angular location/ displacement, study/ analysis and evaluation of both hard and soft tissues as well as other internal organ structures for polyp, lesion, mass, implants, fracture, aneurysms, stenoses etc or evaluation of any abnormality / malformation in specified organs obtained from scanning. It also supports the interactive segmentation of any organ by removing certain structure(s) from display for critical evaluation of selected part(s) of organ. It is intended for use by radiologists. clinicians and referring physicians to acquire, process, render, evaluate, archive, print and distribute DICOM 3.0 compliant specified organ image studies, utilizing PC hardware.

6. Comparison to Predicate Devices:

The Viatronix V3D Explorer Module (V3D Explorer) utilizes the same technological characteristics as the three 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

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features, provide measurement tools for analysis of the observed structures, provide region of interest selection tools to isolate specific features, provide annotation tools to help indicate and describe findings, and provide integrated reporting to distribute the findings.

V3D Explorer and all three predicates provide external 3D views. As with Vitrea 2 and VVS, the V3D Explorer Module utilizes direct volume rendering for all of its 3D views, including transparent volume images and visible surface views. G.E. Navigator utilizes surface extraction techniques for all 3D views. For changing the mapping to opacity during translucent views, V3D Explorer is similar to Vitrea 2 and VVS devices because all use the same technique of volume rendering.

We conclude that the subject device, the Viatronix V3D Explorer, 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 Determination of Substantial Equivalence are as follows:

Scanned image datasets of various patients organs with known abnormalities or status were used as input for testing of software functionalities in accordance with a test protocol. The V3D Explorer software module provided interactive orthogonal and multiplanar reformatted 2D and 3D images from datasets to detect and evaluate the known abnormalities or status of organs. The volume, linear and angular measurement features provided in the software were used to evaluate and quantify any abnormality of organs or status of any internal organ structures.

The V3D Explorer Module has been developed in a manner consistent with accepted standards for software development, including both unit and system integration testing protocols. Testing on 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 3.0 compliant scanned images of any human organs.

We conclude from these tests that V3D Explorer module is substantially equivalent to the predicate devices in its ability to evaluate any human organs.

8. Discussion of Clinical Tests\Evaluations Performed:

Tests and validations on Patients' various organs were performed per protocol. Loaded Patients' scanned organs images to the predicate device. Evaluated various organs using the predicate device and recorded the results of evaluation and quantification.

Same scanned organ images were loaded into the Viatronix V3D Explorer application. Evaluated all Patients' various organs using V3D Explorer application, and recorded the results of evaluation and quantification.

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Evaluation results of both predicate device and V3D Explorer device were same and no significant differences were detected in the results of evaluation.

In conclusion, it was established that the V3D Explorer application is substantially equivalent to the predicate devices.

9. Conclusions:

The Viatronix V3D Explorer has the same intended use and similar technological characteristics as the GE Navigator (K # 954355) Vital Images Vitrea 2, Version 2.1 (K # 002519) and Viatronix Visualization System ( K# 002780). Moreover, tests and validations using Patients' Image data and non-clinical tests performed demonstrated that the Viatronix V3D Explorer application is substantially equivalent to the predicate devices in its ability to review, analyze and evaluate CT/ MR scan images of various organs to facilitate analysis and evaluation of abnormality or malformation in organs by a trained physician. The Viatronix V3D Explorer application does not raise any new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a logo with a stylized bird figure inside a circle. The bird figure is composed of three curved lines, representing the body, wings, and tail. The circle surrounding the bird contains text, which appears to be the name of an organization or department. The text is arranged along the circumference of the circle, with the bird figure positioned in the center.

Public Health Service

od and Drug Administration rporate Boulevard

6 2002

Viatronix, Inc. c/o Jeff D. Rongero Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709

Re: K022789

Trade/Device Name: Viatronix V3D Explorer Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: Class II Product Code: 90 LLZ Dated: August 20, 2002 Received: August 22, 2002

Dear Mr. Rongero:

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. Iisting 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.

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Page 2

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,

Henry C. Brigdon

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

Page of

510(k) Number (if known):

Device Name: Viatronix V3D Explorer

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K022789

Prescription Use OR Over-The-Counter Use

(Per 21 CFR 801.109) (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).