(97 days)
Yes
The "Intended Use / Indications for Use" section explicitly states that VBrain-OAR uses an "artificial intelligence algorithm (i.e., deep learning neural networks)" for contouring. The "Device Description" further details that the contouring algorithm module consists of "deep learning neural networks".
No
The device is a software tool intended to assist in planning and generating contours for radiation therapy, not to directly treat or diagnose. It is described as being for "informational purposes only and not intended for replacing their current standard practice of manual contouring process." The treatment itself is performed using an external platform and finalized by personnel.
No
The device description explicitly states that VBrain-OAR "is not intended to detect tumors for diagnosis." Its purpose is to assist with radiation therapy treatment planning by contouring organs at risk and registering images, which aligns with treatment support rather than diagnosis.
Yes
The device is explicitly described as a "software device" and "software application system" and its components are described as "algorithm modules" and a "workflow management module." There is no mention of accompanying hardware that is part of the device itself.
Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- VBrain-OAR's Function: VBrain-OAR is a software device that processes medical images (MRI and CT) to assist in radiation therapy treatment planning. It contours organs at risk and performs image registration. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states that it assists trained radiotherapy personnel during their clinical workflows of brain tumor radiation therapy treatment planning by providing initial object contours and performing image registration. This is a function related to image processing and planning, not diagnostic testing of biological samples.
Therefore, VBrain-OAR falls under the category of medical image processing software or a medical device used in treatment planning, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The relevant section states "Not Found" for "Control Plan Authorized (PCCP) and relevant text".
Intended Use / Indications for Use
VBrain-OAR is a software device intended to assist trained radiotherapy personnel including, but not limited to, radiologists, radiation oncologists, neurosurgeons, radiation therapists, and medical physicists, during their clinical workflows of brain tumor radiation therapy treatment planning, by providing initial object contours of organs at risk in the brain (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. VBrain-OAR is intended to be used on adult patients only.
VBrain-OAR uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) organs at risk (brain stem, eyes, optic nerves, optic chiasm) in the brain on MRI images for trained radiotherapy personnel's attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain-OAR does not alter the original MRI image, nor does it intend to detect tumors for diagnosis. VBrain-OAR is intended only for contouring and generating contours of organs at risk in the brain; it is not intended to be used with images of other body parts.
VBrain-OAR also contains the automatic image register volumetric medical image data. (e.g., MR, CT). It allows rigid image registration to adjust the spatial position and orientation of two images. Radiation therapy treatment personnel must finalize (confirm or modify) the contours generated by VBrain-OAR, as necessary, using an external platform available at the facility that supports DICOM-RT viewinglediting functions, such as image visualization software and treatment planning system.
Product codes
QKB
Device Description
VBrain-OAR is a software application system indicated for use in the contouring (segmentation) of brain MRI images for the organs at risk (OAR) in the brain during radiation treatment planning and in the registration of multi-modality images. The device consists of 2 algorithm modules, which are contouring algorithm module and registration algorithm module, and a workflow management module. The modules can work independently, and yet can be integrated with each other.
The contouring (segmentation) algorithm module consists of image preprocessing, deep learning neural networks, and postprocessing components, and is intended to contour organs at risk in the brain on the axial T1 contrast-enhanced MR images. It utilizes deep learning neural networks to generate contours for the organs at risk in the brain and export the results as DICOM-RT objects (using the RT Structure Set ROI Contour attribute, RTSTRUCT).
The registration algorithm module registers volumetric medical image data (e.g., MR, CT). It allows rigid image registration to adjust the spatial position and orientation of two images.
The workflow management module is configured to work on a PACS network. Upon user's request, it will pull patient scans or users can send corresponding DICOM images, and it will trigger a predefined workflow, in which different algorithm modules are executed to generate the DICOM output. The DICOM output of a workflow are sent back to the PACS.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Axial T1 contrast-enhanced brain MRI images for segmentation, MR, CT for registration.
Anatomical Site
Brain
Indicated Patient Age Range
Adult patients only.
Intended User / Care Setting
Trained radiotherapy personnel including, but not limited to, radiologists, radiation oncologists, neurosurgeons, radiation therapists, dosimetrists, and medical physicists, during their clinical workflows of brain tumor radiation therapy treatment planning.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Standalone performance testing was conducted to evaluate the contouring (segmentation) performance and registration performance of VBrain-OAR. VBrain-OAR was tested on datasets from multiple institutions.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Standalone performance testing was conducted to evaluate the contouring (segmentation) performance and registration performance of VBrain-OAR. VBrain-OAR was tested on datasets from multiple institutions. The segmentation testing demonstrated that the auto-segmentation algorithm of the VBrain-OAR algorithm module provides clinically acceptable contours for organs at risk in the brain structures on an image of a patient. The registration testing evaluated the quality of the rigid registration of the registration algorithm module on images of multiple modalities, to demonstrate substantial equivalence to the predicate device. Stratified analysis of both testing showed consistent performance on data across patient sex, multiple imaging hardware and protocols.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
October 12, 2021
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Vysioneer Inc. % Vicki Lin Regulatory Specialist 33 Rogers St., # 308 CAMBRIDGE MA 02142
Re: K212116
Trade/Device Name: VBrain-OAR Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QKB Dated: September 10, 2021 Received: September 13, 2021
Dear Vicki Lin:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K212116
Device Name VBrain-OAR
Indications for Use (Describe)
V Brain-OAR is a software device intended to assist trained radiotherapy personnel including, but not limited to, radiologists, radiation oncologists, neurosurgeons, radiation therapists, and medical physicists, during their clinical workflows of brain tumor radiation therapy treatment planning, by providing initial object contours of organs at risk in the brain (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. VBrain-OAR is intended to be used on adult patients only.
V Brain-OAR uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) organs at risk (brain stem, eyes, optic nerves, optic chiasm) in the brain on MRI images for trained radiotherapy personnel's attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain-OAR does not alter the original MRI image, nor does it intend to detect tumors for diagnosis. VBrain-OAR is intended only for contouring and generating contours of organs at risk in the brain; it is not intended to be used with images of other body parts.
V Brain-OAR also contains the automatic image register volumetric medical image data. (e.g., MR, CT). It allows rigid image registration to adjust the spatial position and orientation of two images. Radiation therapy treatment personnel must finalize (confirm or modify) the contours generated by VBrain-OAR, as necessary, using an external platform available at the facility that supports DICOM-RT viewinglediting functions, such as image visualization software and treatment planning system.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Section 5 510(k) Summary K212116
5.1 Submitter
Vysioneer Inc.
33 Rogers St. #308, Cambridge, MA 02142
| Contact Person: | Vicki Lin (Regulatory Specialist) |
|---|---|
| Phone: | 609-865-8659 |
| Email: | vicki.lin@vysioneer.com |
| Date Summary Prepared: | September 10, 2021 |
5.2 Device Name
| Trade Name: | VBrain-OAR |
|---|---|
| Common Name: | Radiological Image Processing Software for |
| Radiation Therapy | |
| Regulation Number / Product Code: | 21 CFR 892.2050 / QKB |
5.3 Predicate Device
Primary Predicate Device: AccuContour™
510(k) Holder/Submitter: Xiamen Manteia Technology LTD.
510(k) Number: K191928 (Cleared on 02/28/2020)
Reference Device: iPlan
510(k) Holder/Submitter: Brainlab AG
510(k) Number: K113732 (Cleared on 05/07/2012)
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Image /page/4/Picture/1 description: The image shows the logo for Vysioneer. The logo consists of the word "Vysioneer" in a sans-serif font, with the letters in a dark blue color. Above the word is a stylized "V" shape, also in dark blue, formed by two angled lines that do not quite meet at the bottom. The overall design is simple and modern.
5.4 Intended Use / Indications for Use
VBrain-OAR is a software device intended to assist trained radiotherapy personnel including, but not limited to, radiologists, radiation oncologists, neurosurgeons, radiation therapists, dosimetrists, and medical physicists, during their clinical workflows of brain tumor radiation therapy treatment planning, by providing initial object contours of organs at risk in the brain (i.e., the region of interest, ROI) on axial T1 contrast-enhanced brain MRI images. VBrain-OAR is intended to be used on adult patients only.
VBrain-OAR uses an artificial intelligence algorithm (i.e., deep learning neural networks) to contour (segment) organs at risk (brain stem, eyes, optic chiasm) in the brain on MRI images for trained radiotherapy personnel's attention, which is meant for informational purposes only and not intended for replacing their current standard practice of manual contouring process. VBrain-OAR does not alter the original MRI image, nor does it intend to be used to detect tumors for diagnosis. VBrain-OAR is intended only for contouring and generating contours of organs at risk in the brain; it is not intended to be used with images of other body parts.
VBrain-OAR also contains the automatic image registration feature to register volumetric medical image data. (e.g., MR, CT). It allows rigid image registration to adjust the spatial position and orientation of two images.
Radiation therapy treatment personnel must finalize (confirm or modify) the contours generated by VBrain-OAR, as necessary, using an external platform available at the facility that supports DICOM-RT viewing/editing functions, such as image visualization software and treatment planning system.
Device Description ર્સ્ડ
VBrain-OAR is a software application system indicated for use in the contouring (segmentation) of brain MRI images for the organs at risk (OAR) in the brain during radiation treatment planning and in the registration of multi-modality images. The device consists of 2 algorithm modules, which are contouring algorithm module and registration algorithm module, and a workflow management module. The modules can work independently, and yet can be integrated with each other.
The contouring (segmentation) algorithm module consists of image preprocessing, deep learning neural networks, and postprocessing components, and is intended to contour organs at risk in the brain on the axial T1 contrast-enhanced MR images. It utilizes deep learning neural networks to generate contours for the organs at risk in the brain and export the results as DICOM-RT objects (using the RT Structure Set ROI Contour attribute, RTSTRUCT).
The registration algorithm module registers volumetric medical image data (e.g., MR, CT). It allows rigid image registration to adjust the spatial position and orientation of two images.
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The workflow management module is configured to work on a PACS network. Upon user's request, it will pull patient scans or users can send corresponding DICOM images, and it will trigger a predefined workflow, in which different algorithm modules are executed to generate the DICOM output. The DICOM output of a workflow are sent back to the PACS.
5.6 Comparison of Technological Characteristics with the Predicate Device
VBrain-OAR is substantially equivalent to the primary predicate device AccuContour™ (K191928).
The proposed device, VBrain-OAR, and the primary predicate, AccuContour™ (K191928) are both AI-based (deep learning) software devices intended to be used in the workflow of radiation therapy treatment planning by providing tools to automatically segment/contour organs at risk on images as well as perform image registration (image fusion). In addition, VBrain-OAR and the predicate device both use an intensity-based algorithm for image registration. Both the proposed device and AccuContour™ (K191928) are regulated under 21 CFR 892.2050, Product Code QKB (Radiological Image Processing Software for Radiation Therapy).
Both the proposed device and the reference device, iPlan (K113732), are designed to contour organs at risk of brain on MR images and perform image registration (image fusion). The only difference between these two software devices is that VBrain-OAR uses an AI-based algorithm, while iPlan uses an atlas-based algorithm for segmentation of images.
Please see Table 5-1 comparing the intended use and key technological characteristics of VBrain-OAR and the predicate and reference device.
| | Proposed Device | Primary Predicate
Device | Reference Device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Vysioneer Inc. | Xiamen Manteia
Technology LTD. | Brainlab AG |
| Device Name | VBrain-OAR | AccuContour™ | iPlan |
| 510k Number | K212116 | K191928 | K113732 |
| Regulation No. | 21CFR 892.2050 | 21CFR 892.2050 | 21CFR 892.1750 |
| Classification | II | II | II |
| Product Code | QKB | QKB | JAK/LLZ |
| Intended
Use/Indication for Use | VBrain-OAR is a
software device intended
to assist trained
radiotherapy personnel | It is used by radiation
oncology department to
register multimodality
images and segment
(non-contrast) CT | iPlan's indications for
use are the viewing,
presentation and
documentation of
medical imaging, |
| Proposed Device | Primary Predicate
Device | Reference Device | |
| including, but not
limited to, radiologists,
radiation oncologists,
neurosurgeons, radiation
therapists, dosimetrists,
and medical physicists,
during their clinical
workflows of brain
tumor radiation therapy
treatment planning, by
providing initial object
contours of organs at
risk in the brain (i.e., the
region of interest, ROI)
on axial T1 contrast-
enhanced brain MRI
images. VBrain-OAR is
intended to be used on
adult patients only.
VBrain-OAR uses an
artificial intelligence
algorithm (i.e., deep
learning neural
networks) to contour
(segment) organs at risk
(brain stem, eyes, optic
nerves, optic chiasm) in
the brain on MRI images
for trained radiotherapy
personnel's attention,
which is meant for
informational purposes
only and not intended
for replacing their
current standard practice
of manual contouring
process. VBrain-OAR
does not alter the
original MRI image, nor
does it intend to be used
to detect tumors for
diagnosis. VBrain-OAR
is intended only for
contouring and
generating contours of
organs at risk in the | images, to generate
needed information for
treatment planning,
treatment evaluation and
treatment adaptation.
The product has two
image process functions:
(1) Deep learning
contouring: it can
automatically contour
the organ-at-risk,
including head and neck,
thorax, abdomen and
pelvis (for both male and
female),
(2) Automatic
Registration, and
(3) Manual Contour.
It also has the following
general functions:
(1) Receive,
add/edit/delete, transmit,
input/export, medical
images and DICOM
data;
(2) Patient management;
(3) Review of processed
images;
(4) Open and Save of
files. | including different
modules for image
processing, image
fusion, atlas assisted
visualization and
segmentation,
intraoperative functional
planning where the
output can be used e.g.
with stereotactic image
guided surgery or other
devices for further
processing and
visualization.
Example procedures
include but are not
limited to:
Planning and
simulation of cranial
surgical procedures such
as tumor resection, shunt
placement, minimal-
invasive stereotactic
interventions, biopsy,
planning and simulation
of trajectories for
stimulation and electrode
recording ENT procedures
such as sinus surgery,
tumor surgery Spine
procedures such as
tumor surgery, pedicle
screw planning,
vertebroplasty planning Plan View is an
application which is
intended to be used for
reviewing existing
treatment plans Planning and
simulation of cranio-
maxillofacial procedures
Typical users of iPlan
are medical | |
| | Proposed Device | Primary Predicate
Device | Reference Device |
| | brain; it is not intended
to be used with images
of other body parts. | | professionals, including
but not limited to
surgeons and
radiologists. |
| | VBrain-OAR also
contains the automatic
image registration
feature to register
volumetric medical
image data. (e.g., MR,
CT). It allows rigid
image registration to
adjust the spatial
position and orientation
of two images. | | |
| | Radiation therapy
treatment personnel
must finalize (confirm or
modify) the contours
generated by VBrain-
OAR, as necessary,
using an external
platform available at the
facility that supports
DICOM-RT
viewing/editing
functions, such as image
visualization software
and treatment planning
system. | | |
| Device Description | VBrain-OAR is a
software application
system indicated for use
in the contouring
(segmentation) of brain
MRI images for the
organs at risk (OAR) in
the brain during
radiation treatment
planning and in the
registration of multi-
modality images. The
device consists of 2
algorithm modules,
which are contouring | The proposed device,
AccuContour, is a
standalone software
which is used by
radiation oncology
department to register
multimodality images
and segment (non-
contrast) CT images, to
generate needed
information for
treatment planning,
treatment evaluation and
treatment adaptation. | iPlan is a software based
treatment planning
application providing
functionalities like
viewing, processing and
documentation of
medical data including
different modules for
image preparation,
image fusion, image
segmentation where the
result is a treatment plan
that can be used e.g. for
stereotactic and/or image
guided surgery. |
| Proposed Device | Primary Predicate
Device | Reference Device | |
| algorithm module and
registration algorithm
module, and a workflow
management module.
The modules can work
independently, and yet
can be integrated with
each other.
The contouring
(segmentation)
algorithm module
consists of image
preprocessing, deep
learning neural
networks, and
postprocessing
components, and is
intended to contour
organs at risk in the
brain on the axial T1
contrast-enhanced MR
images. It utilizes deep
learning neural networks
to generate contours for
the organs at risk in the
brain and export the
results as DICOM-RT
objects (using the RT
Structure Set ROI
Contour attribute,
RTSTRUCT).
The registration
algorithm module
registers volumetric
medical image data (e.g.,
MR, CT). It allows rigid
image registration to
adjust the spatial
position and orientation
of two images.
The workflow
management module is
configured to work on a
PACS network. Upon | The product has two
image process functions:
(1) Deep learning
contouring: it can
automatically contour
the organ-at-risk,
including head and neck,
thorax, abdomen and
pelvis (for both male and
female),
(2) Automatic
Registration, and
(3) Manual Contour.
It also has the following
general functions:
Receive, add/edit/delete,
transmit, input/export,
medical images and
DICOM data;
Patient management;
Review of processed
images;
Open and Save of files. | | |
| | Proposed Device | Primary Predicate
Device | Reference Device |
| | user's request, it will
pull patient scans or
users can send
corresponding DICOM
images, and it will
trigger a predefined
workflow, in which
different algorithm
modules are executed to
generate the DICOM
output. The DICOM
output of a workflow are
sent back to the PACS. | | |
| Segmentation
(Contouring)
Technology | Deep learning | Deep learning | Atlas-based |
| Operating System | Linux operating system | Microsoft Windows | Microsoft Windows |
| User Population | Trained radiotherapy
personnel including, but
not limited to,
radiologists, radiation
oncologists, physicians,
dosimetrists, and
medical physicists. | It is used by radiation
oncology department. | Typical users of iPlan
are medical
professionals, including
but not limited to
surgeons and
radiologists. |
| Supported Modalities | Segmentation Features
for organs at risk in the
brain: axial T1 contrast-
enhanced MR images.
Registration Features:
CT, MR | Segmentation Features:
Non-Contrast CT
Registration Features:
CT, MRI, PET | CT, MRI, PET and
SPECT |
| Image segmentation:
Localization and
Definition of Objects
(ROI) | Organs at risk in the
brain | Organ-at-risk, including
head and neck, thorax,
abdomen and pelvis (for
both male and female) | Outline anatomical
structures using manual
or automatic
segmentation methods.
Advanced manipulation
for 3D objects with
scaling, logical
operations and object
splitting. |
| Image Registration
Algorithm | Intensity-based | Intensity-based | Intensity-based |
| | Proposed Device | Primary Predicate
Device | Reference Device |
| Alteration of Original
Images | No | No | No |
Table 5-1. Comparison with the Predicate and Reference Devices.
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5.7 Non-Clinical Test (Standalone Performance Data)
Standalone performance testing was conducted to evaluate the contouring (segmentation) performance and registration performance of VBrain-OAR. VBrain-OAR was tested on datasets from multiple institutions.
The segmentation testing demonstrated that the auto-segmentation algorithm of the VBrain-OAR algorithm module provides clinically acceptable contours for organs at risk in the brain structures on an image of a patient.
The registration testing evaluated the quality of the rigid registration of the registration algorithm module on images of multiple modalities, to demonstrate substantial equivalence to the predicate device.
Stratified analysis of both testing showed consistent performance on data across patient sex, multiple imaging hardware and protocols.
Software Verification and Validation 5.8
Software verification and validation testing were conducted, and documentation was provided in accordance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for software devices identified as Major Level of Concern related to radiation therapy treatment planning.
રું તે તે Substantially Equivalent (SE) Conclusion
Vysioneer Inc. has conducted performance testing on VBrain-OAR. In all the cases, the software showed clinically acceptable performance. Verification and validation testing and hazard analysis demonstrate that VBrain-OAR performs within its design specifications and is as safe and effective as the predicate. The minor technological differences between VBrain-OAR and the predicate device with regard to the intended use do not introduce any new potential risks. Based on the information presented in these 510(k) premarket notifications, VBrain-OAR is considered substantially equivalent to the predicate device.