(35 days)
VelocityAIS 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 is not intended for mammography diagnosis.
VelocityAIS 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. VelocityAIS is used as a stand-alone application on recommended Off-The-Shelf (OTS) computers supplied by the company or by the end-user.
Here's a breakdown of the acceptance criteria and the study information for K070248 (Velocity AIS), based on the provided text:
Important Note: The provided document is a 510(k) summary for a pre-market notification, not a detailed study report. As such, it primarily focuses on establishing substantial equivalence to predicate devices and demonstrating that the software meets its functional specifications. It does not contain extensive details about clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy, reader studies, or detailed ground truth methodologies that would be typical for a device making a diagnostic claim based on AI.
Acceptance Criteria and Reported Device Performance
The document does not explicitly present specific numerical "acceptance criteria" for diagnostic performance (e.g., sensitivity, specificity, AUC) or a comparative table of "reported device performance" against such criteria.
Instead, the core of the acceptance criteria for this 510(k) is based on:
- Functional Specifications and Performance Requirements: The device must meet its own defined functional specifications and performance requirements.
- Substantial Equivalence: The device must be demonstrated as "substantially equivalent" to legally marketed predicate devices, meaning it is similar in characteristics, materials, features, technological features, intended use, and indications for use, and does not pose any new issues of safety and effectiveness.
The reported device "performance" is implicitly stated as:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Functional Specifications | Velocity Medical Solutions has verified and validated that the VelocityAIS software meets its functional specifications and performance requirements. |
| Safety and Effectiveness | "does not introduce any new potential safety risks, is as effective, and performs as well as devices currently on the market" (referring to predicate devices). |
| Substantial Equivalence | Similar in characteristics, materials, features, technological features, intended use, and indications for use as the predicates; does not pose any new issues of safety and effectiveness. |
Study Details (Based on available information)
Given the nature of the 510(k) summary, specific details about "studies" in the context of diagnostic accuracy or deep learning models are limited. The provided text describes primarily the verification and validation (V&V) of the software's functional specifications and its comparison to predicate devices, rather than a clinical performance study as one might expect for a new diagnostic AI.
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2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any "test set" in the context of diagnostic performance. The document only mentions "medical imaging data from multiple DICOM conformant imaging modality sources."
- Data Provenance: Not specified. No mention of country of origin or whether the data was retrospective or prospective.
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3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. There is no mention of experts or ground truth establishment for a diagnostic test set. The validation seems to be primarily functional.
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4. Adjudication method for the test set:
- Not specified. This is not applicable given the lack of detail on a diagnostic test set and ground truth establishment.
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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:
- No, an MRMC comparative effectiveness study is not mentioned or described. The device is characterized as aiding "during use by diagnostic radiology, oncology, radiation therapy planning and other medical specialties," but no study on human reader improvement with or without AI assistance is detailed.
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6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document states, "VelocityAIS is a stand-alone software product." This implies independent functionality. However, it's not a "standalone performance study" in the sense of an algorithm making a diagnostic claim without human oversight. Its stated use is "as an aid" for physicians, suggesting a human-in-the-loop model for clinical decision-making. No metrics for standalone diagnostic accuracy are provided.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the context of clinical or diagnostic performance. The ground truth refers to whether the software meets its internal "functional specifications and performance requirements," rather than a clinical truth.
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8. The sample size for the training set:
- Not applicable/not specified. This device predates the widespread use of deep learning in medical imaging diagnostics for which a "training set" of patient data would be a primary concern. Its function involves image display, co-registration, fusion, ROI drawing, and calculation, which are rule-based software functionalities, not statistical learning from a large training dataset.
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9. How the ground truth for the training set was established:
- Not applicable/not specified, for the same reasons as #8. Ground truth for training would not be relevant for this type of software as described.
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Pre-Market Notification 510(k) Summary
MAR 0 1 2007
Sponsor Information: 1.
Contact Person:
Contact Title:
Company Name & Address:
Velocity Medical Solutions, LLC 1118 Zimmer Drive, Atlanta, GA 30306
Timothy Fox, PhD President 404-272-9217 Contact Phone Number: 404-873-8326
Date of Summary:
Contact Fax Number:
January 24, 2007
Velocity AIS
2. Device Name and Classification:
Common and Usual Name:
Proprietary Name:
Classification Name:
Performance Standards:
Picture Archiving and Communication System (Medical Imaging Software)
Image Processing System, Radiology (21 CFR § 892.2050)
No applicable performance standards have been issued under section 514 or under section 513(b) of the Food. Drug and Cosmetic Act.
3. Predicate Device(s):
GE Medical Systems, Advantage Windows CT/PET Fusion (K010336) GE Medical Systems. Volume Viewer Plus (K041521) MIMvista Corp., MIMviewer (K062163)
4. Description of Device:
VelocityAIS 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.
Velocity Medical Solutions, LLC
VelocityAIS SSE Page 1 of 2
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VelocityAIS 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: ડ.
VelocityAIS is a software package 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 is not intended for mammography diagnosis.
Comparison with Predicate Device(s): 6.
The VelocityAIS is substantially equivalent to the predicate devices (MIMvista Corp MIMviewer , GE Medical Advantage Windows CT/PET Fusion and GE Medical Volume Viewer Plus). VelocityAIS 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 software meets its functional specifications and performance requirements.
Conclusions: 8.
In summary, Velocity Medical Solutions, LLC, is of the opinion that the VelocityAIS 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 Velocity AIS is substantially equivalent to the predicate devices.
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Image /page/2/Picture/0 description: The image shows a circular seal with text around the perimeter and a stylized eagle in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The eagle is depicted with three curved lines representing its body and wings, and a wavy line at the bottom representing its tail.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 0 ] 2007
Velocity Medical Solutions, LLC % Mr. Paul Summer Director, Regulatory & Quality Systems ARKIN Consulting Group 1733 Canton Lane MARIETTA GA USA 30062
Re: K070248
· Trade/Device Name: Velocity AIS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systme Regulatory Class: II Product Code: LLZ Dated: January 24, 2007 Received: January 25, 2007
Dear Mr. Summer:
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/2/Picture/10 description: The image is a black and white circular logo. The letters "FDA" are prominently displayed in the center of the logo. Above the letters "FDA" are the roman numerals "XIX-XX". Below the letters "FDA" is the word "Centennial" and three stars. The logo appears to be a commemorative emblem, possibly related to the centennial of the Food and Drug Administration (FDA) or another organization with the same initials.
Protecting and Promoting Public Health
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Page 2 -
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/cdrl/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
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
Device Name: VelocityAlS
Indications For Use:
VelocityAIS 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 is not intended for mammography diagnosis.
Prescription Use XX (Part 21 CFR 801 Subpart D)
ANDIOR
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)
Page 1 of
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number -
§ 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).