VelocityAIS (VelocityAI) is a stand-alone software product that provides the physician a means for comparison of medical imaging data from multiple DICOM conformant imaging modality sources. It allows the display, annotating, volume rendering, registration and fusing of medical images as an aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties. VelocityAIS (VelocityAI) is not intended for mammography diagnosis.

Device Description

Version 2.0 of VelocityAIS, also marketed as VelocityAI with this version, is a stand-alone software product that provides medical image processing designed to facilitate the oncology or other clinical specialty work flow by allowing the comparison of medical imaging data from different modalities, points in time, and/or scanning protocols. The product provides users with the means to display, co-register and fuse medical images from multiple modalities including PET, SPECT, CT, and MR, draw Regions of Interest (ROI), calculate, and report relative differences in pixel intensities, Standardized Uptake Value (SUV) or other values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices. Version 2.0 of the product contains the additional features of: Automated deformable registration. Anatomical atlas based segmentation tools. Operating systems compatibility with MicroSoft Windows XP Home and Professional (Service Pack 2), MicroSoft Vista Home and Professional, Linux (CentOS) and MacOSX (Leopard). VelocityAIS (VelocityAI) is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.

AI/ML Overview

The provided document is a 510(k) Pre-Market Notification Summary for the VelocityAIS (also "VelocityAI") software, version 2.0. This document primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific clinical study with granular performance metrics and acceptance criteria for a novel device function.

Here's a breakdown of the requested information based on the provided text, and explicit statements about what is not available in this document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not explicitly defined as quantitative performance criteria in this submission.	"Verified and validated that the VelocityAIS (VelocityAI) software meets its functional specifications and performance requirements."

Explanation: The document states that the software "meets its functional specifications and performance requirements" but does not provide a table of quantifiable acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, processing speed) or specific numerical performance results. The core of this 510(k) is about demonstrating substantial equivalence to existing predicate devices, implying that its performance is equivalent or better without introducing new safety/effectiveness concerns.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not mentioned in the provided text.
Data Provenance: Not mentioned in the provided text. The document describes the software's capabilities with "medical imaging data from multiple DICOM conformant imaging modality sources" but does not specify the origin or nature of the data used for verification/validation.
Retrospective/Prospective: Not mentioned in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not mentioned in the provided text. The document focuses on software functionality and comparison to predicate devices, not on the details of a clinical reader study or the establishment of ground truth by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not mentioned in the provided text.

5. 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

Not mentioned in the provided text. This 510(k) summary does not describe an MRMC comparative effectiveness study or the impact of AI assistance on human readers. The device is described as "medical image processing designed to facilitate the oncology or other clinical specialty work flow" and providing "a means for comparison of medical imaging data," but it doesn't quantify improvements in human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the device as a "stand-alone software product" that provides image processing capabilities, implying its functionality without direct human intervention in its core processing. However, it's an "aid during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties," meaning human experts interpret the output.
Performance of the algorithm only (e.g., specific metrics for deformable registration or segmentation accuracy): Not explicitly detailed in the provided text. The claim is general: "verified and validated that the VelocityAIS (VelocityAI) software meets its functional specifications and performance requirements."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not mentioned in the provided text.

8. The sample size for the training set

Not mentioned in the provided text. The document does not describe the training of any AI/ML models, though it mentions "Automated deformable registration" and "Anatomical atlas based segmentation tools" which could imply the use of such models.

9. How the ground truth for the training set was established

Not mentioned in the provided text.

In summary, the provided 510(k) document is a regulatory submission focused on substantial equivalence. It confirms that the manufacturer verified and validated the software's functional specifications and performance requirements. However, it does not contain the detailed clinical study information (e.g., specific acceptance criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness study results) that is typically found in a clinical validation report for a device with advanced diagnostic capabilities. This type of information is often provided in more detailed validation reports or during later clinical trials, which are not part of this initial 510(k) summary for a "Picture Archiving and Communication System (Medical Imaging Software)" with image processing features.

Summary

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JUN 2 0 2008

Pre-Market Notification 510(k) Summary

1. Sponsor Information:

Company Name & Address:	Velocity Medical Solutions, LLC75 Fifth Street, Suite 221, Atlanta, GA 30309
Contact Person:	Timothy Fox, Ph.D.
Contact Title:	President
Contact Phone Number:	404-272-9217
Contact Fax Number:	404-873-8326
Date of Summary:	April 4, 2008
Device Name and Classification:
Common and Usual Name:	Picture Archiving and Communication System(Medical Imaging Software)
Proprietary Name:	VelocityAIS or VelocityAI
Classification Name:	Image Processing System, Radiology(21 CFR § 892.2050)
Performance Standards:	No applicable performance standards have been issuedunder section 514 or under section 513(b) of the FoodDrug and Cosmetic Act.

Predicate Device(s): 3.

Velocity Medical Solutions. Velocity AIS (K070248) GE Medical Systems, Advantage Windows CT/PET Fusion (K010336) GE Medical Systems, Volume Viewer Plus (K041521) MIMvista Corp., MIMVista (K071964)

4. Description of Device:

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values within those regions, and import and export results to and from commercially available radiation treatment planning systems and PACS devices.

Version 2.0 of the product contains the additional features of:

Automated deformable registration .
Anatomical atlas based segmentation tools .
Operating systems compatibility with MicroSoft Windows XP Home and . Professional (Service Pack 2), MicroSoft Vista Home and Professional, Linux (CentOS) and MacOSX (Leopard).

VelocityAIS (VelocityAI) is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.

Indications for Use: in

Comparison with Predicate Device(s): 6.

The VelocityAIS (VelocityAI) software is substantially equivalent to the predicate devices identified. It is similar in characteristics, materials, features, has similar technological features, intended use and indications for use as the predicates, and does not pose any new issues of safety and effectiveness.

Non-Clinical Performance Summary: 7.

Velocity Medical Solutions has verified and validated that the VelocityAIS (VelocityAl) software meets its functional specifications and performance requirements.

8. Conclusions:

In summary, Velocity Medical Solutions, LLC, is of the opinion that the modified VelocityAIS (VelocityAI) does not introduce any new potential safety risks, is as effective, and performs as well as devices currently on the market, and concludes that the product is substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles an eagle or bird.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2008

Velocity Medical Solutions, LLC % Mr. Paul Sumner Vice President of Regulatory Quality & Clinical Systems Arkin Consulting Group, LLC 1733 Canton Lane MARIETTA GA 30062

Re: K081076

Trade/Device Name: VelocityAIS (also "VelocityAI") Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 21, 2008 Received: May 23, 2008

Dear Mr. Sumner:

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 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.

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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 Center for Devices and Radiological Health's (CDRH's) 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely vours.

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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Indications for Use Statement

510(k) Number (if known): K070248 Ko81076

VelocityAIS (also "VelocityAl") Device Name:

Indications For Use:

Prescription Use XX (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number K 081076

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).