(240 days)
K220141 RayStation 11B
None
Yes
The summary explicitly mentions "deep learning segmentation" and the use of "trained deep learning models" for automatic segmentation.
No.
This device is a treatment planning system that proposes and helps administer treatment plans, but it does not directly deliver therapy.
No
Explanation: RayStation is described as a "treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans," and is also used to "administer treatments." While it involves analysis, its primary function is treatment planning and administration, not diagnosis. It takes patient images and data to create a treatment plan, not to identify a disease or medical condition.
No
The device description explicitly states that RayStation is a "software system" and "consists of multiple applications" built on a "software platform". While it interacts with hardware (treatment delivery devices, imaging systems), the core device being described and submitted for 510(k) is the software itself. The description focuses on software functionalities, algorithms, and databases.
Based on the provided information, RayStation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body in vitro (outside the body) to provide information for diagnostic, monitoring, or compatibility purposes.
- RayStation's Intended Use: RayStation is a software system for radiation therapy and medical oncology treatment planning and administration. It uses patient images and data to propose and administer treatment plans. This is a therapeutic and treatment management function, not an in vitro diagnostic function.
- Device Description: The description focuses on treatment planning, dose calculation, and treatment administration, all of which are related to delivering therapy to the patient's body, not analyzing specimens outside the body.
- Input: While it uses patient images (CT, PET, MR), these are used for anatomical context and planning, not for in vitro analysis of bodily fluids or tissues.
In summary, RayStation's purpose is to assist in the planning and delivery of radiation therapy and medical oncology treatments, which falls under the category of therapeutic or treatment management devices, not In Vitro Diagnostics.
No
The Input section explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found," indicating the letter does not mention FDA review and approval or clearance of a PCCP for this device, per the Key Decision Rules.
Intended Use / Indications for Use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
Product codes (comma separated list FDA assigned to the subject device)
MUJ
Device Description
RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. The device lets the user import patient images and data, identify treatment targets and organs at risk, create an optimal treatment plan taking into account patient anatomy, prescribe treatment dose and organ at risk sensitivity, review and approve the plan and then administer the treatment. A scientific basis for the device is the implementation of peer reviewed algorithms of plan parameter optimization and photon and particle dose calculation.
RayStation consists of multiple applications:
- . The main RayStation application is used for treatment planning.
- The RayPhysics application is used for commissioning of treatment machines to make ● them available for treatment planning and used for commissioning of imaging systems.
- The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.
These applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data.
The RayStation application is divided in modules, which are activated through licensing. A simplified license configuration of RayStation is marketed as RayPlan has a limited set of modules, indicated in the following table.
The device to be marketed, RayStation 12A, contains modified features compared to version RayStation 11B as indicated below:
- Support for eye planning with wedges
- A wedge can be used to improve the conformity of dose distribution and spare risk O organs. The wedge is not patient specific, meaning that the user must choose a wedge from a predefined set of wedges for the treatment machine. Each wedge in the machine model is associated with an identifying name, a physical opening angle, and a material.
- Automatic field in field planning ●
- A uniform dose can be achieved on a selected target using automatically generated 3Do CRT fields/segments. Starting from a number of beams (usually 2 or 3) and an initial segment for each beam the action sequentially adds a given number of segments to each beam, choosing apertures and segment weights so that the final dose is approximately uniform on the target. The apertures of the inner segments always have openings that are subsets of the openings of the respective initial segments.
- Brachy therapy support for Elekta Flexitron® afterloaders
- The connectivity to the Elekta Flexitron® afterloader is validated for the brachy planning O in RayStation using the TG43 formalism.
- Electron Monte Carlo dose engine update .
- O The previously used plug-in for in-patient transport for the electron Monte Carlo dose engine (VMC++) was replaced by a fully integrated electron Monte Carlo dose engine. In the development of the new dose engine, improvements have been made to increase the accuracy for small cutout sizes.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes - "With deep learning segmentation, the user can use trained deep learning models for automatic segmentation of new patient images."
Input Imaging Modality
CT, PET, MR, CBCT
Anatomical Site
Not Found - "persons that have been prescribed an external beam radiation therapy or medical oncology treatment."
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Authorized intended users
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing were conducted. The software for this device was considered as a "Major" level of concern.
Support for eye planning with wedges: Validation was performed as part of the dose engine validation for proton ocular treatments. Test cases covered line doses in homogeneous phantoms using a square aperture and a wedge mounted with varying opening angles and positions. Depth dose curves with ranges and modulations were used. Depth-dose profiles along the central axis were acquired with a plane-parallel chamber in a water tank. Requirements related to the SOBP distal fall-off of the central axis depth dose curve and 95% and 98% of the computed depth dose values with Gamma pass rates were met. The proton dose computation for proton ocular treatments in RayStation 12A has been successfully validated for accuracy in clinically relevant settings.
Automatic field in field planning: Validation of the new feature for creating field in field plans was performed as part of the overall system validation. Requirements were that for a 3D-CRT plan, merged beams' MU agree with original beams' MU, merged beams' segments keep original shapes, and MU and segment weights after split are subdivided correctly with split beams managed correctly in terms of ordering and ROI handling. Testing showed that segment MUs and shapes agree, beam and segment administration and handling are correct, and all beams created by the split beam action have the same Treat and Protect ROIs as the beam that was split. These tests demonstrate that RayStation 12A can safely perform field in field planning.
Brachy Therapy now support Elekta Flexitron® afterloaders: Validation of the HDR brachytherapy planning for Elekta Flexitron afterloaders was performed as part of the Dose Engine validation of Brachy TG43. Computed doses were compared with reference doses from published consensus data, measurements, independent and well-established systems for dose computation, and an independent Monte Carlo software. The validation demonstrates that the dose computation is adequate for clinical use.
Electron Monte Carlo dose engine update: The validation strategy was to compare doses computed with RayStation 12A to reference doses from measured doses, doses computed in a well-established competing TPS, doses computed with earlier versions of RayStation, and doses computed in BEAMnrc/egs++. Two different gamma criteria for comparison with another TPS or measurement were evaluated for each test case, with specified requirements on level of agreement. The fraction of calculated dose data points that failed for comparison with previous RayStation dose and BEAMnrc/egs++ was evaluated. Validation of the new dose engine has been performed which demonstrates that the dose computation is adequate for clinical use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K220141 RayStation 11B
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
March 29, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
RaySearch Laboratories AB (publ) % David Hedfors Quality and Regulatory Affairs Director Eugeniavagen 18 Stockholm, 113 68 SWEDEN
Re: K222312
Trade/Device Name: RayStation 12A Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: MUJ Dated: July 26, 2022 Received: August 1, 2022
Dear David Hedfors:
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/cfpmn/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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see 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.
Image /page/1/Picture/5 description: The image shows the name "Lora D. Weidner" in a large, sans-serif font. The name is stacked vertically, with "Lora D." on the top line and "Weidner" on the bottom line. The text is black against a white background.
Digitally signed by Lora D. Weidner -S Date: 2023.03.29 10:20:55 -04'00'
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222312
Device Name RayStation 12A
Indications for Use (Describe)
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
| 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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3
510(k) Summary 1.
1.1 510(k) owner
RaySearch Laboratories AB (publ) Eugeniavägen 18 113 68 Stockholm Sweden
Tel: +46 8 510 530 00
1.2 Contact person
David Hedfors Quality and Regulatory Affairs Director RaySearch Laboratories AB (publ) Email: quality@raysearchlabs.com +46 722 366 110 Tel:
1.3 Preparation date
March 28th, 2023.
1.4 Trade name
The trade name is RayStation.
The marketing name is RayStation 12A and RayPlan 12A.
1.5 Common name
Radiation therapy treatment planning system
1.6 Classification name
Medical charged-particle radiation therapy system (21 CFR 892.5050, Product Code MUJ)
1.7 Predicate device
K220141 RayStation 11B
1.8 Device description
RayStation is a treatment planning system for planning, analysis and administration of radiation therapy and medical oncology treatment plans. The device lets the user import patient images and data, identify treatment targets and organs at risk, create an optimal treatment plan taking into account patient anatomy, prescribe treatment dose and organ at risk sensitivity, review and approve the plan and then administer the treatment. A scientific basis for the device is the implementation of peer reviewed algorithms of plan parameter optimization and photon and particle dose calculation.
RayStation consists of multiple applications:
- . The main RayStation application is used for treatment planning.
- The RayPhysics application is used for commissioning of treatment machines to make ● them available for treatment planning and used for commissioning of imaging systems.
- The RayTreat application is used for sending plans to treatment delivery devices for treatment and receiving records of performed treatments.
These applications are built on a software platform, containing the radiotherapy domain model and providing GUI, optimization, dose calculation and storage services. The platform uses three Microsoft SQL databases for persistent storage of the patient, machine and clinic settings data.
The RayStation application is divided in modules, which are activated through licensing. A simplified license configuration of RayStation is marketed as RayPlan has a limited set of modules, indicated in the following table.
4
| Planning activity | Module | Available in
RayPlan |
|-------------------------|------------------------------|-------------------------|
| Automated planning | Plan explorer | No |
| Automated planning | Automated breast planning | No |
| Automated planning | Fallback planning | No |
| Automated planning | Fallback protocol management | No |
| Patient data management | Patient data management | Yes |
| Patient modeling | Image registration | Yes |
| Patient modeling | Structure definition | Yes |
| Patient modeling | Deformable registration | No |
| Patient modeling | Eye modeling | No |
| Plan design | Virtual simulation | Yes |
| Plan design | Plan setup | Yes |
| Plan design | 3D-CRT beam design | Yes |
| Plan design | Electron beam design | Yes |
| Plan design | Proton beam design | No |
| Plan design | Brachy planning | Yes |
| Plan optimization | Plan optimization | Yes |
| Plan optimization | Multi criteria optimization | No |
| Plan evaluation | Plan evaluation | Yes |
| Plan evaluation | Robust evaluation | No |
| Plan evaluation | Biological evaluation | No |
| QA preparation | QA preparation | Yes |
| Treatment adaptation | Dose tracking | No |
| Treatment adaptation | Adaptive replanning | No |
In each planning activity the user can perform some operations that are considered to form a basic task or planning activity in oncology. Together, the planning activities cover a complete treatment planning use case. Each planning activity consists of one or more modules; each corresponding to a coherent group of functionalities. A module may include one or several workspaces, where each workspace holds an optimized layout of regions populated with GUI components that are needed to get through the use case of the module.
The device to be marketed, RayStation 12A, contains modified features compared to version RayStation 11B as indicated below:
- Support for eye planning with wedges
- A wedge can be used to improve the conformity of dose distribution and spare risk O organs. The wedge is not patient specific, meaning that the user must choose a wedge from a predefined set of wedges for the treatment machine. Each wedge in the machine model is associated with an identifying name, a physical opening angle, and a material.
- Automatic field in field planning ●
5
- A uniform dose can be achieved on a selected target using automatically generated 3Do CRT fields/segments. Starting from a number of beams (usually 2 or 3) and an initial segment for each beam the action sequentially adds a given number of segments to each beam, choosing apertures and segment weights so that the final dose is approximately uniform on the target. The apertures of the inner segments always have openings that are subsets of the openings of the respective initial segments.
- Brachy therapy support for Elekta Flexitron® afterloaders
- The connectivity to the Elekta Flexitron® afterloader is validated for the brachy planning O in RayStation using the TG43 formalism.
- Electron Monte Carlo dose engine update .
- O The previously used plug-in for in-patient transport for the electron Monte Carlo dose engine (VMC++) was replaced by a fully integrated electron Monte Carlo dose engine. In the development of the new dose engine, improvements have been made to increase the accuracy for small cutout sizes.
1.9 Indications for Use
RayStation is a software system for radiation therapy and medical oncology. Based on user input, RayStation proposes treatment plans. After a proposed treatment plan is reviewed and approved by authorized intended users, RayStation may also be used to administer treatments.
The system functionality can be configured based on user needs.
1.10 Technological characteristics summary
The following comparison table summarized the technological characteristics. In the table below, RayStation 12A is compared to the predicate device RayStation 11B.
| Item | Compared to
RayStation 11B | Comment |
|-----------------------------------------------------|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hardware platform | Substantially Equivalent | Both systems use standard office PCs as hardware platform. |
| Operating system | Substantially Equivalent | Both systems use Windows 10 Professional (or higher) and
Windows Server 2012 R2 (or higher). |
| Target population | Substantially Equivalent | RayStation 11B and RayStation 12A are intended for the
same target population and anatomical sites; persons that |
| Anatomical sites | Substantially Equivalent | have been prescribed an external beam radiation therapy or
medical oncology treatment. |
| Human factors | Substantially Equivalent | In terms of human factors, the systems are considered
equivalent. The user interfaces are almost identical. |
| Standards met | Substantially Equivalent | Both systems comply with the following FDA-recognized
consensus standards: IEC 61217:2011, IEC 62083, IEC
62304:2015, IEC 62366-1:2015, ISO 14971:2019 and with
IEC 60601-2-68:2014 standard. |
| Image types | Substantially Equivalent | RayStation 11B and RayStation 12A both support CT, PET
and MR images for identifying patient organs and contouring. |
| Reporting aspects | Substantially Equivalent | When evaluating and approving treatment plans, all necessary
data is presented to the user and available in print in both
systems. |
| Image storing | Substantially Equivalent | None of the systems is intended for long term storage of
images or other patient data. |
| Network / remote
connections and
capabilities | Substantially Equivalent | Both systems are capable of network transfer of patient data
using the DICOM protocol. RayStation 12A and RayStation
11B are designed for desktop use and for remote access using
standard virtualization techniques. Remote connection to the
system is verified in detail and equivalent to local connection. |
6
| Cybersecurity | Substantially Equivalent | Both systems are compliant with the requirements listed in
the FDA guideline 1825 "Content of Premarket Submissions
for Management of Cybersecurity in Medical Devices". |
| --------------- | -------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| Feature | Description | Present in
RayStation
11B
(K220141) | Present in
RayStation
12A | Significantly
changed? |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------------------|------------------------------------------------------------------------------------|
| 3D
visualization | Displays the patient geometry and
structures in three dimensions, with the
possibility to rotate the patient image. If
available, the dose distribution and beam
modifiers are shown as well. | Yes | Yes | No |
| Adaptive
replanning | The process of replanning the treatment
for a patient, based on information about
e.g. patient geometry, biology and dose
delivery acquired during treatment. | Yes | Yes | No |
| Beam
commissioning | Modeling of the radiation beam using a
limited set of measurements on the clinical
beam for commissioning treatment
machines to make them available for
treatment planning. | Yes | Yes | No |
| Beam design | Definition of beam orientations, apertures
and various beam modifiers in order to
manually create a treatment plan. | Yes | Yes | No |
| Beam set-up | Manual or automatic definition of
isocenter, selection of treatment unit from
the set of commissioned treatment
machines, and specification of
gantry/couch/collimator angles. | Yes | Yes | Yes, new
functionality
Automatic
Field in Field
planning was
added. |
| Beam's eye
view | Displays the beam's eye view of the
patient structures, fluence and beam
modifier settings for any beam. | Yes | Yes | No |
| Brachy
planning | Tools for planning of HDR brachytherapy
treatments. Includes channel
reconstruction and optimization and
editing of dwell times. | Yes | Yes | Yes. Now
supports
Elekta
Flexitron
afterloaders. |
| CyberKnife
planning | CyberKnife planning is completely
integrated in RayStation. This includes
optimization of high quality treatment
plans collimated with MLC, fixed cones
or iris cones, as well as support for all
CyberKnife Synchrony techniques for
target tracking and real time motion
synchronization. | Yes | Yes | No |
| Deformable
registration | Establishing a point-to-point mapping
between two images using a deformation
model. Used for mapping of dose and
structures between images. | Yes | Yes | No |
| DICOM RT
export | Export of images, structure set, plan, and
dose according to the DICOM RT
standard. | Yes | Yes | No |
| DICOM RT
import | Import of images, structure set, plan, and
dose according to the DICOM RT
standard. | Yes | Yes | No |
| Dose
calculation
electrons | For electron beams RayStation calculates
dose by the Monte Carlo technique. The
electron beam phase space is generated in
run time by sampling from a phase space
model where the electrons are created at
the secondary scattering foil. Both the
electron transport through the treatment
head and the in-patient dose computation
is performed using the Monte Carlo
algorithm.
In versions prior to RayStation 11A, the
transport through the treatment head has
been handled by a Monte Carlo algorithm
developed by RaySearch, while the in-
patient transport and dose computation has
been the responsibility of the plug-in dose
engine VMC++. In RayStation 12A, the
VMC++ dose engine has been exchanged
with an in-patient Monte Carlo transport
and dose scoring algorithm fully
developed by RaySearch. Additionally,
some minor improvements have been
made to the treatment head transport, but
this part is essentially the same as in
RayStation 11B.
There are substantial similarities between
the replaced VMC++ code and the
EGSnrc code and these two Monte Carlo
dose engines agrees on sub-percent level
[1][2]. The dose engine developed by
RaySearch is similar to the EGSnrc, as has
been described in references 11, 12, 17, 24
and 108 in the 008 RSL-D-RS-12A-REF-
EN-1.0-2022-06-23 RayStation 12A
Reference Manual. Therefore, we
conclude that the electron dose engine
used in RayStation 12A (fully developed
by RaySearch) is substantially equivalent
to the electron dose engine used in
RayStation 11B (in-patient dose
computation handled by VMC++). | Yes | Yes | Yes |
| | | | | |
| | The supporting testing confirms
equivalence between the RayStation 11B
and RayStation 12A dose engines.
Regression tests performed during the
electron dose engine validation between
the two versions are within tolerance
limits which shows a similar level of
accuracy between the two dose engines.
Acceptance criteria for comparison with
previous RayStation dose: The calculated
doses shall fail for less than 2% of the data
points for gamma 2%/2mm.
References:
| | | |
| | Society (Cat. No.00CH37143), Chicago,
IL, USA, 2000, pp. 1490-1493 vol.2, doi:
10.1109/IEMBS.2000.898024.
[2] Kawrakow I, Fippel M, Friedrich K.
3D electron dose calculation using a
Voxel based Monte Carlo algorithm
(VMC). Med Phys. 1996 Apr;23(4):445-
57. doi: 10.1118/1.597673. PMID:
9157256. | | | |
| Dose
calculation
photons | For photon beams RayStation calculates
dose by the point kernel superposition
method (a.k.a. Collapsed Cone) or a
Monte Carlo algorithm for radiation
transport. The incident energy fluence is
modeled as a superposition of a primary
energy fluence and a scatter energy
fluence. The dose contribution from
contamination electrons is calculated by a
pencil beam algorithm. | Yes | Yes | No |
| Dose
calculation
proton | For proton beams RayStation uses either
the pencil beam algorithm with the Fermi-
Eyges formalism, or a Monte Carlo
algorithm for radiation transport. For
passive beams the beam model accounts
for the collimator and compensator block.
For scanning beams the beam model
accounts for the spot phase space
including effects of air-scatter and beam
paths through magnetic deflection
elements. The user defined block aperture
is taken into account in spot selection and
optimization. In addition to this the
relative biological effect (RBE) of proton
beams is taken into account, resulting in a
photon equivalent dose. | Yes | Yes | No |
| Dose
calculation
brachy | For brachy plans RayStation calculates
dose based on the TG43 formalism. | Yes | Yes | No |
| Dose display
(2D) | Displays the patient geometry with
structures superimposed on the image data
together with the dose distribution in
transversal, sagittal, and coronal
directions. | Yes | Yes | No |
| Dose tracking | Dose tracking scenarios including
deformable registration of one CT or
CBCT to another and subsequent
deformation and accumulation of dose. | Yes | Yes | No |
| Eye planning | Tools for specifying a highly detailed
geometrical model of the eye based on
measurements from ultrasound and
surgery. Support for positioning of
tantalum clips. Import and visualization of
fundus images. Creation and dose
computation of proton plans with gaze
angle-based treatment directions. | Yes | Yes | Yes, Now
supports eye
planning with
wedges. |
| Fallback
planning | Automatic generation of fallback plans
using alternative treatment machines and
treatment techniques. User-defined
protocols specifies the setup of the
fallback plans which are automatically
generated from the protocols and
optimized using dose mimicking
functions. | Yes | Yes | No |
| Image
conversion | Conversion of CBCT images to synthetic
CT images that can be used for more
accurate dose calculations. | Yes | Yes | No |
| Inverse
planning | The user can define optimization settings
such as optimization tolerance and
maximum number of iterations as well as
segmentation settings on the multileaf
collimator and the Pencil Beam Scanning
spot pattern. An interface for controlling
the optimization process is provided and
the progress of optimization is displayed
in a view. The system generates control
points for step-and shoot MLC plans,
Sliding Window plans (DMLC), rotational
plans (VMAT), 3DCRT plans, Wave Arc
plans, TomoTherapy plans and proton
Pencil Beam Scanning plans, using the
defined optimization problem. The inverse
planning can be carried out either through
a conventional inverse approach or by
using multi-criteria optimization (photons
and protons only). | Yes | Yes | No |
| LET evaluation | Computation and evaluation of dose-averaged LET (Linear Energy Transfer) for proton plans. LET is an additional physical quantity that can be used to assess the radiobiological effect of the proton radiation. | Yes | Yes | No |
| Machine database | Microsoft SQL database for storage of beam model parameters, machine constraints and dose curves with dosimetric data for treatment units. | Yes | Yes | No |
| MR based planning | Allowing MR-images as planning images and base dose computation on material override ROIs. | Yes | Yes | No |
| Optimization functions | The optimization functions are specified in terms of objectives and constraints to form the optimization problem that is solved by the optimization engine. | Yes | Yes | No |
| Patient anatomy modeling | Manual and semi-automatic segmentation tools for contouring ROIs slice by slice together with semi-automated generation of the patient outline ROI.
The model-based segmentation technique allows for semi-automatic delineation of structures by matching 3D shape models of the structures to new image data.
With atlas-based segmentation, the user can define templates consisting of already segmented image data and use this template for segmentation of new patient images.
With deep learning segmentation, the user can use trained deep learning models for automatic segmentation of new patient images. (The model training is performed offline on clinical CT and structure data.) | Yes | Yes | No |
| Patient database | Microsoft SQL database for storage of all patient and plan data. Not for long term storage. | Yes | Yes | No |
| Plan Explorer | The system computes a large set of plans according to given rules and the user is provided with tools to select good plans from these. | Yes | Yes | No |
| Quality assurance preparation | Tools for transferring the clinical plan to a phantom and recalculate dose. The output is the dose distribution in DICOM format or a 2D dose plane and a QA report.
Predicted EPID response is retrieved by photon dose computation in a specially designed phantom. | Yes | Yes | No |
| RBE dose
handling | RBE (Relative Biological Effectiveness)
models can be defined and commissioned.
For proton treatments, the user can select
whether to look at RBE-corrected dose or
physical dose. Dose summation is only
possible for photon doses and RBE-
corrected proton doses. | Yes | Yes | No |
| Robust
evaluation | Tools used to answer questions of how the
dose distribution would appear if the
patient setup at the time of treatment does
not fully correspond to the planning CT. A
model of patient uncertainties such as CT
inaccuracy and setup errors is used to
compute a set of scenario doses for
evaluation. | Yes | Yes | No |
| Robust
optimization | Optimization where a model of patient
uncertainties such as CT inaccuracy, setup
errors or organ motion is used during the
optimization. | Yes | Yes | No |
| Scripting | Scripting gives programmatic access to
functionality, excluding user risk
mitigations. Through scripting, the clinic
specific procedures can be automated. The
operating system and other applications
can be accessed. | Yes | Yes | No |
| Supported | HFS, FFS, HFP, FFP | Yes | Yes | No |
| treatment
positions | Decubitus left/right | Yes | Yes | No |
| | Seated position (for ions) | Yes | Yes | No |
| System
integrity tools | Hardware based license, preventing
unauthorized useable copies to be made.
Checksum control of binary files to
prevent tampering. Data in the patient and
machine databases only available for users
with administrator rights. | Yes | Yes | No |
| TomoTherapy
planning | Planning for TomoTherapy machines is
completely integrated in RayStation. Also
provides tools for selection of targets and
imaging angles for the TomoTherapy
machine to use for target tracking during
delivery. | Yes | Yes | No |
| Treatment
adaptation | A general concept where the treatment
plan is adapted during the course of
treatment. Tools available today include
deformable dose accumulation, CBCT
dose calculation and replanning scenarios. | Yes | Yes | No |
| Treatment plan
approval | Approval of the preferred treatment plan
and referenced ROIs by authorized
medical staff. Once a treatment plan is
approved, it is locked for any further
modification. | Yes | Yes | No |
| Treatment plan
creation | Treatment plan creation with specification
of plan properties such as number of
fractions and delivery technique. | Yes | Yes | No |
| Treatment plan
evaluation | Evaluation of a single plan. Comparison
of dose distributions and DVH curves of
two or three plans. | Yes | Yes | No |
| Treatment
delivery | An approved plan can be assigned to
fractions in a treatment course and sent to
the treatment delivery device. RayTreat
offer treatment room interfaces for patient
positioning, imaging and plan delivery. | Yes | Yes | No |
| Undo/redo and
auto recovery | The undo stack is saved to the database,
enabling recovery of RayStation after
crash. The user may redo all or selected
changes at reopen of patient after crash. | Yes | Yes | No |
| Virtual
Simulation | Setup of isocenter, beam arrangements
and basic aperture design. Export to laser
systems for patient marking. | Yes | Yes | No |
Detailed technology comparison table:
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1.11 Assessment of non-clinical performance data
Software verification and validation testing were 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, since a failure or latent flaw in the software could directly result in serious injury or death to the patient.
Support for eye planning with wedges - Validation of the eye planning feature extended to include wedges was performed as part of the dose engine validation for proton ocular treatments. The test cases cover line doses in homogeneous phantoms using a square aperture and a wedge mounted with varying opening angles and positions. Depth dose curves with ranges and modulations are used in the validation. An interval is used for the opening angle of the wedge and for the lateral position of the opening edge of the wedge with respect to the central axis. Depth-dose profiles along the central axis were acquired with a plane-parallel chamber in a water tank. The accuracy requirements are related to:
- . The SOBP distal fall-off of the central axis depth dose curve
- . 95% and 98% of the computed depth dose values with Gamma pass rates
The requirements are met by the data in the validation report. The proton dose computation for proton ocular treatments in RayStation 12A has been successfully validated for accuracy in clinically relevant settings according to specification.
Automatic field in field planning - Validation of the new feature for creating field in field plans for e.g. 3DCRT plans with multiple segments in each beam was performed as part of the overall system validation.
The requirements are that
- . For a 3D-CRT plan, the merged beams' MU shall agree with original beams' MU.
- Merged beams' segments shall keep original shapes.
- . MU and segment weights after split are subdivided correctly and that split beams are managed correctly in terms of ordering and ROI handling.
Testing shows that the segment MUs and shapes agree, beam and segment administration and handling are correct and that all beams created by the split beam action have the same Treat and Protect ROIs as the beam that was split. These tests demonstrate that RayStation 12A can safely perform field in field planning.
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Brachy Therapy now support Elekta Flexitron® afterloaders – Validation of the HDR brachytherapy planning for Elekta Flexitron afterloaders was performed as part of the Dose Engine validation of Brachy TG43.
Computed doses have been compared with reference doses, i.e. from published consensus data sets, from measurements or from independent and well-established systems for dose computation. The reference doses consist of point doses, line doses, as well as 2D and 3D doses. The reference dose sources are
- . Published consensus data
- . Measured doses
- Doses computed in two major competing TPS ●
- . Doses computed with an independent Monte Carlo software
RayStation provides support for TG43 dose computation with user specified TG43 parameters for any applicable source. Comparison to OA along-away data ensures that the dose engine can accurately reproduce the dose for a variety of sources given that the input data is correct. Measurement from EQUAL-ESTRO relates computed dose to delivered dose for a setup with three dwell positions. Comparison to an independent and TG43 compliant treatment planning system is used to further validate the correct superposition of dose from a large number of dwell positions. Finally, the comparison to an independent Monte Carlo system decouples the dependence to the TG43 formalism and provides a fully independent validation of a complete treatment plan. The validation demonstrates that the dose computation is adequate for clinical use.
Electron Monte Carlo dose engine update – The electron dose calculation in RayStation supports LINACs using the dual foil scattering technique with applicators and cutouts. The dual foil assembly shapes the electron beam phase space in the upper part of the treatment head (i.e. towards the vacuum window). The applicator and cutout further shape the beam to yield clinically usable lateral flatness and penumbras while minimizing radiation leakage outside of the field.
The electron phase space model in RayStation is designed to model the arrangement sketched above. The implementation is parameter driven and thus generic with respect to a typical dual foil, applicator and cutout arrangement.
The validation strategy is to compare doses computed with RayStation 12A to reference doses. The different reference doses used are
- . Measured doses.
- . Doses computed in a well-established competing TPS.
- . Doses computed with earlier versions of RayStation.
- . Doses computed in BEAMnrc/egs++.
Two different gamma criteria for comparison with another TPS or measurement are evaluated for each test case, with specified requirements on level of agreement.
The fraction of the calculated dose data points for comparison with previous RayStation dose that fail has been evaluated, and the fraction of the calculated dose data points for comparison to BEAMnrc/egs++ that fail has been evaluated.
Validation of the new dose engine has been performed which demonstrates that the dose computation is adequate for clinical use.
1.11.1 Conclusion
The non-clinical data support the safety of the device and the software verification and validation demonstrate that the RayStation 12A device should perform as intended in the specified use conditions, and the performance testing demonstrates that the RayStation 12A device performs comparably to the predicate device that is currently marketed for the same intended use.