Velocity is a software package that provides the physicians a means for comparison of medical data including imaging data that is DICOM compliant. It allows the display, annotation, volume rendering, registration, and fusion of medical images as an aid during use by diagnostic radiology, radiation therapy planning and other medical specialties. Velocity is not intended for mammography.

Device Description

Velocity is a software application providing relevant tools for Radiotherapy professionals to use while creating treatment plans. The Velocity device is a Picture Archiving and Communication System (medical imaging software). Velocity 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 analyze medical images from multiple modalities including PET, SPECT, CT, RT Dose 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 / export results to/from commercially available radiation treatment planning systems and PACS devices. Co-registration includes deformable registration technology that can be applied to DICOM data including diagnostic and planning image volumes, structures, dose, and automatic anatomical atlas-based segmentation tools. Velocity 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) Premarket Notification for the "Velocity" software. It focuses on demonstrating substantial equivalence to a predicate device ("Velocity AI – K081076") and does not contain detailed information about specific acceptance criteria, test set sizes, expert qualifications, or comparative effectiveness studies typically associated with proving a device meets strict performance benchmarks via a clinical study with AI components.

However, based on the information provided, we can infer some aspects and highlight what is explicitly stated:

Key Takeaways from the Document:

Device Type: Velocity is a "Picture Archiving and Communication System (Medical Imaging Software)" designed for display, annotation, volume rendering, registration, and fusion of medical images for diagnostic radiology, radiation therapy planning, and other medical specialties.
Predicate Device Approach: The submission relies on demonstrating "substantial equivalence" to a legally marketed predicate device (Velocity AI – K081076) and a secondary predicate for a specific feature (MIM Y90 Dosimetry - K172218).
No Clinical Tests: The document explicitly states: "No clinical tests have been included in this pre-market submission." This immediately tells us that the detailed performance studies often associated with AI/ML model validation (e.g., MRMC studies, standalone performance with robust ground truth) were not part of this submission for the core functionality.
Software Verification & Validation (V&V): The primary performance data cited is "Software Verification and Validation Testing," indicating a focus on functional correctness, reliability, and safety of the software rather than a direct clinical performance evaluation. The software was considered a "major" level of concern.
Ground Truth: Given no clinical tests, there's no mention of how ground truth for a test set was established using expert consensus, pathology, or outcomes data for clinical performance metrics. The ground truth for V&V would be tied to software requirements and specifications.
AI/ML Context: While "AI" is in the predicate device name ("Velocity AI"), the listed functionalities of "Velocity" (display, annotation, volume rendering, registration, fusion) are standard PACS and image processing features. The "deformable registration technology" and "automatic anatomical atlas-based segmentation tools" could be considered AI/ML elements, but the document does not detail specific performance studies of these elements with clinical ground truth.

Based on the available text, here's an attempt to answer your questions. Please note that many answers will state that the information is "Not provided" or "Not applicable" due to the nature of this 510(k) submission, which did not include clinical performance studies.

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

The document does not provide a specific table of acceptance criteria with corresponding reported device performance metrics in the way a clinical study typically would (e.g., sensitivity, specificity, F1-score for an AI component). The performance data cited is:

Acceptance Criteria Category	Nature of Performance Demonstrated	Reported Device Performance
Functional Equivalence	Comparison to predicate device	"Velocity 4.0 performs similar to the predicate device VelocityAIS v2.0 (K081076) for the functions contained within the predicate" (Implied from comparison table and substantial equivalence claim).
Safety & Effectiveness	Software Verification & Validation	"The non-clinical data support the safety of the device and the software verification and validation demonstrate that the Velocity device performs as intended."
Specific Feature Equivalence (Y90 Dosimetry)	Comparison to secondary predicate	"MIM Y90 Dosimetry (K172218) was determined to be a predicate for the RapidSphere SPECT Microsphere Dosimetry feature. Both features: are intended for post-treatment absorbed dose calculation and evaluation, are compatible with Y90 PET and SPECT image types, and use the Local deposition model for dose calculation."

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 specified. As "No clinical tests have been included," there isn't a "test set" in the context of clinical performance evaluation using patient data for AI validation. The V&V would use internal test cases.
Data Provenance: Not specified.

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 applicable. Since no clinical tests were performed for the submission, there is no mention of external experts establishing ground truth for a clinical test set.

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

Not applicable. No clinical tests were performed.

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. The document explicitly states: "No clinical tests have been included in this pre-market submission." Therefore, an MRMC comparative effectiveness study was not performed or submitted.

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

Not specified in a clinical performance context. While the software operates "as a stand-alone application," this refers to its deployment rather than a standalone algorithmic performance study against clinical ground truth. The V&V process would have involved testing the algorithm's functional performance against specified requirements.

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

For Software Verification and Validation: The ground truth would be defined by the software requirements and specifications (e.g., expected output for given input, correctness of calculations, proper display of images). This is a technical ground truth, not a clinical one derived from patient outcomes or expert consensus on a diagnosis.
For Clinical Performance: Not applicable, as no clinical tests were performed.

8. The sample size for the training set

Not specified. The document does not describe the development or training of any AI/ML components beyond mentioning "deformable registration technology" and "automatic anatomical atlas-based segmentation tools." No information is provided regarding the training data or its size.

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

Not specified. As there is no information on a specific training set or the development process for embedded AI/ML features, how any training ground truth was established is not detailed.

Summary

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February 15, 2018

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Varian Medical Systems, Inc. % Mr. Peter J. Coronado Director, Global Regulatory Affairs 3100 Hansen Way PALO ALTO CA 94304

Re: K173636

Trade/Device Name: Velocity Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 22, 2017 Received: November 24, 2017

Dear Mr. Coronado:

We have reviewed vour 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K173636

Device Name Velocity

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

[X] Prescription Use (Part 21 CFR 801 Subpart D)

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

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Premarket Notification [510(k)] Summary

Velocity 4.0

The following information is provided following the format of 21 CFR 807.92(c).

Submitter's Name:	Varian
	3100 Hansen Way E-110
	Palo Alto, CA 94304

	Contact Name: Peter J. Coronado
	Phone: 650.424.6320
	Fax: 650.646.9200

	Date: February 6, 2018
Proprietary Name:	Velocity
Classification Name:	Image Processing System, Radiology
	21 CFR 892.2050, Class II
	Product Code: LLZ

Common/Usual Name:	Picture Archiving and Communication System (Medical Imaging Software)
Predicate Devices:	Primary predicate: Velocity AI – K081076
	Secondary predicate: MIM Y90 Dosimetry - K172218
Device Description:	Velocity is a software application providing relevant tools for Radiotherapy
	professionals to use while creating treatment plans.
	The Velocity device is a Picture Archiving and Communication System (medical imagingsoftware). Velocity 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 analyze medical
	images from multiple modalities including PET, SPECT, CT, RT Dose 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 /
	export results to/from commercially available radiation treatment planning systemsand PACS devices. Co-registration includes deformable registration technology that can
	be applied to DICOM data including diagnostic and planning image volumes,
	structures, dose, and automatic anatomical atlas-based segmentation tools.

	Velocity is used as a stand-alone application on recommended Off-The-Shelf (OTS)
	computers supplied by the company or by the end-user.
Intended Use Statement	Velocity is a software package that provides the physicians a means for comparison of
	medical data including imaging data that is DICOM compliant.
	It allows the display, annotation, volume operation, volume rendering, registration,
	and fusion of medical images as an aid during use by diagnostic radiology, oncology,
	radiation therapy planning and other medical specialties. Velocity is not intended for
	mammography.
Indications for Use	Velocity is a software package that provides the physicians a means for comparison of
Statement	medical data including imaging data that is DICOM compliant.
	It allows the display, annotation, volume operation, volume rendering, registration,
	and fusion of medical images as an aid during use by diagnostic radiology, oncology,
	radiation therapy planning and other medical specialties. Velocity is not intended for
	mammography.

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Technological Characteristics:

VELOCITY 4.0 - DEVICE COMPARISON TABLE
FEATURE AND/OR SPECIFICATION OFNEW/MODIFIED DEVICE	VELOCITYAIS v2.0K081076	VELOCITY 4.0
Indications for Use/Intended Use	VelocityAIS (VelocityAl) is a stand-alone software product thatprovides the physician a meansfor comparison of medical imagingdata from multiple DICOMconformant imaging modalitysources. It allows the display,annotating, volume rendering,registration and fusing of medicalimages as an aid during use bydiagnostic radiology, oncology,radiation therapy planning andother medical specialties.VelocityAIS (VelocityAI) is notintended for mammographydiagnosis.	Velocity is a software package thatprovides the physicians a meansfor comparison of medical dataincluding imaging data that isDICOM compliant.It allows the display, annotation,volume operation, volumerendering, registration, and fusionof medical images as an aid duringuse by diagnostic radiology,oncology, radiation therapyplanning and other medicalspecialties.Velocity is not intended formammography diagnosis.
General Usage/ Performance Features
Image Study Importation	YesDICOM, PET/SPECT/CT/MRIDose	YesDICOM, PET/SPECT/CT/MRIDoseQuery/Retrieve automation addedin 4.0
Image Structure Import, Save & Exportto Treatment Planning Systems	Yes	Yes
Volume rendering	Yes	Yes4D Cine Volume support in 4.0.0
Advanced Visualization and NavigationFeatures	Yes	Yesmulti-volume view support in 4.0
Volume Operations	No	Yes
Diagnostic Image registration	Yes	Yes
Image Fusion	Yes	Yes
Anatomical and Functional Images	Anatomical and Functional Images
ROI & Contouring	Yes	Yes
Manual Contouring Tools	Yes	Yes
Image Analysis	Yes	Yes
Plan Review of imported plans orcreated dose composites	No	Yes
Oncology workflow automation	No	Yes
Image/ROI Export to DICOM RT	Yes	Yes
Secure login and data storage	Yes	Yes
Operating System Platform	Microsoft Windows XP 32 bitonly/Windows 7, Vista	Microsoft Windows 7 & 10 (64 bitonly)/ Windows Server 2008R2(Citrix), 2012R2, 2016
	MAC OSX 10.6	MAC OS 10.12 Sierra, macOS 10.13High Sierra
Multimodality DICOM Import
Import and display DICOM CT, MR, DS,PET, RTS, RTP	Yes	Yes
Advanced Visualization & Navigation
General image viewer with view layoutselection and toolbars	Yes	Yes
Volume Operations
User scaling of image volumes	No	Yes
Biological Effective Dose (BED) Scaling	No	Yes
Y-90 Microsphere Dosimetry -	No	Yes
conversion of SPECT to DS
Automated Image-based Registration
Manual registration editing	Yes	Yes
Auto Rigid Registration	Yes	Yes
Deformable Registration	Yes	Yes
Inverse deformable registration	No	Yes
Structure Guided deformable	No	Yes
Segmentation (Manual Contouring Tools and Atlas Segmentation)
Manual Contouring tools	Yes	Yes
Atlas Auto-Segmentation	Yes	Yes
Image analysis with volumetric graphs
Histograms and Voxel Assessmentgraphs	Yes	Yes
DVH statistics display	Yes	Yes
Plan Review
Storage and display of DICOM RT Plans	No	Yes
Lesion volume tracking by associatingstructure with name tag	No	Yes
Navigator Semi-Automated Workflows
Semi-automatic workflows to assistwith common clinical imageregistration & analysis tasks	No	Yes
Adaptive Navigators to assist in offlinedose review: includes workflows tocreate adaptive CT based on CBCTregistration, copy plan to adaptive CT,and compare dose.	No	Yes
Security
Logging of database activity	No	Yes

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MIM Y90 Dosimetry (K172218) was determined to be a predicate for the RapidSphere SPECT Microsphere Dosimetry feature. Both features:

are intended for post-treatment absorbed dose calculation and evaluation
are compatible with Y90 PET and SPECT image types
and use the Local deposition model for dose calculation.

Performance Data:

Software Verification and Validation Testing

Software verification and validation was conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.

Clinical Tests No clinical tests have been included in this pre-market submission.

Conclusions

The non-clinical data support the safety of the device and the software verification and validation demonstrate that the Velocity device performs as intended. Varian therefore considers Velocity 4.0 to be safe and effective and to perform at least as well as the predicate device.

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).