(83 days)
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
The Varian Eclipse™ Treatment Planning System (Eclipse TPS) provides software tools for planning the treatment of malignant or benign diseases with radiation. Eclipse TPS is a computer-based software device used by trained medical professionals to design and simulate radiation therapy treatments. Eclipse TPS is capable of planning treatments for external beam irradiation with photon, electron, and proton beams, as well as for internal irradiation, (brachytherapy) treatments.
The provided text is a 510(k) Premarket Notification for the Eclipse Treatment Planning System, a software device used for radiotherapy treatment planning. It details the device's features, comparison to predicate devices, and a summary of non-clinical testing.
However, the document does not contain information about acceptance criteria or a study proving the device meets these criteria in the context of an AI/ML algorithm's performance (e.g., accuracy, sensitivity, specificity, or human improvement with AI assistance).
Instead, the document focuses on demonstrating substantial equivalence to a predicate device primarily through feature comparison and general verification/validation of software functionality.
Therefore, most of the specific questions regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert involvement, and ground truth establishment cannot be answered from the provided text.
Here's an attempt to answer the questions based only on the information available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The document states that the outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable. This acts as a high-level qualitative acceptance criteria for the entire system's functionality and safety.
- Reported Device Performance: The document concludes that "Varian therefore considers Eclipse 13.5 to be safe and to perform at least as well as the predicate device." No specific quantitative performance metrics (e.g., accuracy percentages, sensitivity/specificity, or a table of such) are provided for individual features or the system as a whole in the context of an AI/ML model's output. The performance is implied by the successful conclusion of verification and validation without critical discrepancies.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "Verification and Validation were performed for all the new features and regression testing was performed against the existing features of Eclipse." However, it does not specify the sample size of any test set (e.g., number of patient cases, treatment plans) used for this testing.
- Data Provenance: Not mentioned. It's a software system for planning, so "data" might refer to simulated or clinical patient data, but its origin or nature (retrospective/prospective) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not mentioned. The testing described is software verification and validation, not a clinical performance study involving expert image interpretation or similar. The "ground truth" for software testing would typically be based on expected software behavior, calculations, and adherence to specifications rather than expert consensus on medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not mentioned. This concept is more relevant to studies establishing ground truth for diagnostic or prognostic AI models, which is not the primary focus of this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study was NOT done (or at least not reported in this summary). The document details changes to a treatment planning system, including "RapidPlan (previously known as Dose Volume Histogram Estimation)" and "support for mARC treatment planning by Siemens treatment machines." While RapidPlan involves a type of estimation, the document does not present it as a diagnostic AI requiring human reading assistance with an associated MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes "Non-clinical Testing" including "Verification and Validation" and states that "The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable." This implies significant standalone testing of the software's functionality and calculations. However, no specific performance metrics like accuracy, precision for the algorithms (e.g., AcurosXB, RapidPlan) are presented in a quantitative way for independent assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For a treatment planning system, "ground truth" for testing primarily involves:
- Mathematical/Physical Models: Comparing calculated dose distributions and parameters against established physics principles and validated models.
- Predicate Device Comparison: Ensuring new features produce results consistent with or improved over previously validated predicate devices.
- Software Requirements/Specifications: Ensuring all features function according to their defined specifications.
- The document indicates that "System requirements created or affected by the changes can be traced to the test outcomes," suggesting that meeting the requirements served as a form of ground truth. It also notes "regression testing was performed against the existing features of Eclipse," implying comparison to the established behavior of the predicate. No mention of expert consensus on medical image ground truth, pathology, or outcomes data is made.
8. The sample size for the training set
- Not mentioned. The document describes a treatment planning system rather than a deep learning model requiring explicit training sets of medical images/data in the modern AI sense. While "RapidPlan" involves "Dose Volume Histogram Estimation" which might learn from previous plans, the specifics of its "training set" (if any) are not detailed here.
9. How the ground truth for the training set was established
- Not mentioned. As the existence and nature of a "training set" are not explicitly discussed, the method for establishing its ground truth is also not provided.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Varian Medical Systems, Inc. % Mr. Peter Coronado Director, Regulatory Affairs 911 Hansen Way PALO ALTO CA 94304
Re: K141283
Trade/Device Name: Eclipse Treatment Planning System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: MUJ Dated: April 30, 2014 Received: May 16, 2014
Dear Mr. Coronado:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 (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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris 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) K141283
Device Name Eclipse Treatment Planning System
Indications for Use (Describe)
The Eclipse Treatment Planning System (Eclipse TPS) is used to plan radiotherapy treatments with malignant or benign diseases. Eclipse TPS is used to plan external beam irradiation with photon, electron and proton beams, as well as for internal irradiation (brachytherapy) treatments. In addition, the Eclipse Proton Eye algorithm is specifically indicated for planning proton treatment of neoplasms of the eye.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Michael D'Hara
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PREMARKET NOTIFICATION
510(k) Summary
Eclipse Treatment Planning System
As required by 21 CFR 807.92
| Submitter's Name: | Varian Medical Systems3100 Hansen Way, m/s E110Palo Alto CA94304 |
|---|---|
| Contact Name: Peter J. Coronado-Director Regulatory AffairsPhone: 650/424.6230Fax: 650/646.9200E-mail: submissions.support@varian.comDate: 30th April 2014 | |
| Proprietary Name: | Eclipse Treatment Planning System |
| Classification Name: | system,planning,radiation therapy treatment21CFR892.5050, MUJ, Class II |
| Common/Usual Name: | Eclipse TPS, Eclipse, Treatment Planning System. |
| Predicate Devices: | Eclipse Treatment Planning System 13 (K133247)Eclipse Treatment Planning System 12 (K131891) |
| Device Description: | The Varian Eclipse™ Treatment Planning System (Eclipse TPS)provides software tools for planning the treatment of malignantor benign diseases with radiation. Eclipse TPS is a computer-basedsoftware device used by trained medical professionals todesign and simulate radiation therapy treatments. Eclipse TPS iscapable of planning treatments for external beam irradiation withphoton, electron, and proton beams, as well as for internalirradiation, (brachytherapy) treatments. |
| Indications for Use: | The Eclipse Treatment Planning System (Eclipse TPS) is used toplan radiotherapy treatments for patients with malignant orbenign diseases. Eclipse TPS is used to plan external beamirradiation with photon, electron and proton beams, as well as forinternal irradiation (brachytherapy) treatments. In addition, theEclipse Proton Eye algorithm is specifically indicated forplanning proton treatment of neoplasms of the eye. |
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Changes in Technological Characteristics:
The significant changes compared with the predicate are changes associated with RapidPlan (previously known as Dose Volume Histogram Estimation) and also changes to the algorithm related to support for mARC treatment planning by Siemens treatment machines.
The complete list of changes and their related requirements can be found in the document Tracing Changed/New Features to System Requirements in Section 18 of this submission.
Device Comparison Table
| ECLIPSE TPS V12.0(510(k) ID # K131891) | ECLIPSE TPS V13.0(510(k) ID #K133247) | ECLIPSE TPS V13.5 | |
|---|---|---|---|
| 2. General Usage | |||
| External beam PHOTONplanning | yes | yes | yes |
| External beam PHOTONinverse planning | yes | yes | yes |
| External beam ELECTRONplanning | yes | yes | yes |
| External beam PROTONplanning | yes | yes | yes |
| External beam OCULARPROTON planning (EOPP) | no | yes | yes |
| Internal BRACHYTHERAPYplanning | yes | yes | yes |
| Stereotactic Frame Localization | yes | yes | yes |
| 3. Supported External Beams& Accessories | |||
| Photon beams | yes | yes | yes |
| Electron beams | yes | yes | yes |
| Proton beams | yes | yes | yes |
| Coplanar fields | yes | yes | yes |
| Non-coplanar fields | yes | yes | yes |
| Multi-leaf Collimators | yes | yes | yes |
| Asymmetric collimators | yes | yes | yes |
| Stereotactic Cone collimators | yes | yes | yes |
| Arc fields | yes | yes | yes |
| Poured Blocks | yes | yes | yes |
| Compensators | yes | yes | yes |
| Physical wedges | yes | yes | yes |
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| Dynamic wedges | yes | yes | yes |
|---|---|---|---|
| Flattening filter free support(FFF) | yes | yes | yes |
| Rotating treatment couch | yes | yes | yes |
| 4. Supported BrachytherapySources & Accessories | |||
| Plan for high dose rateafterloader | yes | yes | yes |
| Manual low dose ratebrachytherapy: seeds, linesources, wire | yes | yes | yes |
| Applicator library | yes | yes | yes |
| Needle templates | yes | yes | yes |
| Seed templates | no | no | yes |
| 5. Graphical User Interface | |||
| Multiple-instance application | yes | yes | yes |
| Multiple-workspace layout | yes | yes | yes |
| Graphical display/editing offield parameters | yes | yes | yes |
| Beam's-Eye-View display | yes | yes | yes |
| 3D patient image display | yes | yes | yes |
| Model for human Eye | yes | yes | yes |
| SRS Localization application | yes | yes | yes |
| SRS Planning application | yes | yes | yes |
| Biological Optimizationapplication | yes | yes | yes |
| Biological Evaluationapplication | yes | yes | yes |
| 3D Conformal Optimizationapplication | yes | yes | yes |
| 6. Image Processing | |||
| Orthogonal image displays (3) | yes | yes | yes |
| Oblique image display | yes | yes | yes |
| Edge enhancement filters | yes | yes | yes |
| Image smoothing filters | yes | yes | yes |
| CT/MR/PET Image Registration | yes | yes | yes |
| Image blending utility | yes | yes | yes |
| 4D image display (registrationof time series of 3D images) | yes | yes | yes |
| Digitally reconstructedradiographs | yes | yes | yes |
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| Enclosed Volumemeasurement | yes | yes | yes |
|---|---|---|---|
| Stereotactic Frame Coordinatetransformation | yes | yes | yes |
| 7. Image Segmentation | |||
| Geometrical shapes | yes | yes | yes |
| Manual editing andmanipulation tools | yes | yes | yes |
| Automatic /semi-automatictools | yes | yes | yes |
| Automatic/semi-automatic on-demand and post-processingtools for individualorgans/structures | yes | yes | yes |
| 3D Automargin | yes | yes | yes |
| Logical operators | yes | yes | yes |
| Enhanced 2D and 3Dcontouring tools | no | yes | yes |
| Enhanced 4D functionality,including structure propagationand display of respiratoryamplitude distribution | no | yes | yes |
| 8. Dose Calculation | |||
| Distributed CalculationFramework | yes | yes | yes |
| Photon calculation | yes | yes | yes |
| - Energy Range | 1 MV – 50 MV | 1 MV – 50 MV | 1 MV – 50 MV |
| - CT-based volumetriccalculation | yes | yes | yes |
| - Non-CT based IRREGcalculation | yes | yes | yes |
| - Convolution method | yes | yes | yes |
| - Combined electron/photonscatter | yes | yes | yes |
| - Directional heterogeneitycorrection | yes | yes | yes |
| - Treatment head modelling | yes | yes | yes |
| - Photon Monitor Unitcalculation | yes | yes | yes |
| - Compensator monitor unitcalculation | yes | yes | yes |
| - Beam Angle Optimization(GEOS) | yes | yes | yes |
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| - Dose Dynamic Arc planning | yes | yes | yes |
|---|---|---|---|
| - Cone Dose Calculation | yes | yes | yes |
| - Biological optimization | yes | yes | yes |
| - 3D Conformal Optimization | yes | yes | yes |
| - IMRT optimization | yes | yes | yes |
| - AcurosXB dose calculationalgorithm | yes | yes | yes |
| - Range Uncertainty featurefor photons | no | yes | yes |
| - Siemens mArc | no | no | yes |
| Electron calculation | yes | yes | yes |
| - Energy Range | 1 MeV - 50 MeV | 1 MeV - 50 MeV | 1 MeV - 50 MeV |
| - Gaussian Pencil Beam Model | yes | yes | yes |
| - Electron Monte Carloalgorithm | yes | yes | yes |
| - Electron Monitor Unitcalculation | yes | yes | yes |
| Proton calculation | yes | yes | yes |
| - Energy Range | 50 MeV - 300 MeV | 50 MeV - 300 MeV | 50 MeV - 300 MeV |
| - Single scattering technique | yes | yes | yes |
| - Double scattering technique | yes | yes | yes |
| - Uniform scanning technique | yes | yes | yes |
| - Modulated scanningtechnique | yes | yes | yes |
| - Optimization for modulatedscanning | yes | yes(new implementationforProton Optimizer) | yes |
| - Monitor unit calculation formodulated scanning | yes | yes | yes |
| - Range uncertainty featurefor Protons | yes | yes | yes |
| Brachytherapy calculation | yes | yes | yes |
| - AAPM TG 43 compliant | yes | yes | yes |
| - Point Dose calculation | yes | yes | yes |
| - Optimization to point doseconstraints | yes | yes | yes |
| - Geometric optimization | yes | yes | yes |
| - AcurosBV dose calculationalgorithm | yes | yes(with support forreport the dose tomedium) | yes |
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| Eclipse Algorithm ApplicationProgramming Interface (EAAPI) | yes | yes | yes |
|---|---|---|---|
| RapidPlan - Dose VolumeHistogram (DVH) Estimation | yes | no | Yes(extended DoseVolume Histogram(DVH) Estimation) |
| 9. Dose evaluation | |||
| Dose color wash | 2D, 3D | 2D, 3D | 2D, 3D |
| Isodose levels | 2D, 3D | 2D, 3D | 2D, 3D |
| Isodose Surface | 3D | 3D | 3D |
| Reference point dose summary | yes | yes | yes |
| Dose Volume Histogram plot | yes | yes | yes |
| Plan summing tool | yes | yes | yes |
| Plan comparison tools | yes | yes | yes |
| Evaluation using biologicalmodels | yes | yes | yes |
| 10. Plan Output - Hardcopy | |||
| Graphics window screen dump | yes | yes | yes |
| Patient administration data | yes | yes | yes |
| Plan parameters | yes | yes | yes |
| Geometrical displays of plandata | yes | yes | yes |
| Dose distribution | yes | yes | yes |
| DVH plot | yes | yes | yes |
| BEV display | yes | yes | yes |
| Patient orientation | yes | yes | yes |
| User Configurable hardcopylayouts | yes | yes | yes |
| Import/Export11.Interfaces | |||
| ARIA RadOnc integration | yes | yes | yes |
| DICOM RT | yes | yes | yes |
| Other image formats | yes | yes | yes |
| Electromagnetic Digitizer | import | import | import |
| Eclipse Scripting API (ESAPI)read only access | yes | yes(includes alsoBrachyVision) | yes(includes alsoBrachyVision) |
| Eclipse Scripting API (ESAPI)write access | no | yes(in research database,only) | yes(in research database,only) |
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| Export field coordinates toLaser System | yes | export | export |
|---|---|---|---|
| Basic RT Prescriptioninformation available | no | yes | yes |
Non-clinical Testing
Verification and Validation were performed for all the new features and regression testing was performed against the existing features of Eclipse. System requirements created or affected by the changes can be traced to the test outcomes.
Conclusion of Non-Clinical testing
The outcome was that the product conformed to the defined user needs and intended uses and that there were no DRs (discrepancy reports) remaining which had a priority of Safety Intolerable or Customer Intolerable. Varian therefore considers Eclipse 13.5 to be safe and to perform at least as well as the predicate device.
Argument for Substantial Equivalence to the Predicate Device
A subset of features of the current device is different to the predicate. Of these, the significant changes compared with the predicate are associated with RapidPlan (previously known as Dose Volume Histogram Estimation) and also changes to the algorithm related to support for mARC treatment planning by Siemens treatment machines. Other changes are the addition of new BrachyVision features.
These changes are all considered by Varian to be enhancements of the Indications for Use and the Intended Use remain unchanged. There are no changes in the principle of operation of the software. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. Varian therefore believes that Eclipse TPS is substantially equivalent to the predicate.
§ 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.