(30 days)
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).
Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
Mobius3D (v. 2.2) is a software product used within a radiation therapy clinic for quality assurance and treatment plan verification. It is important to note that while Mobius3D operates in the field of radiation therapy, it is neither a radiation delivery device (e.g. a linear accelerator), nor is it a treatment planning system (TPS). Mobius3D cannot design or transmit instructions to a delivery device, nor does it control any other medical device. Mobius3D is an analysis tool meant solely for quality assurance (QA) purposes when used by trained medical professionals. Being a software-only QA tool, Mobius3D never comes into contact with patients.
Mobius3D performs dose calculation verifications for radiation treatment plans by doing an independent calculation of radiation dose. Radiation dose is initially calculated by a treatment planning system (TPS), which is a software tool that develops a detailed set of instructions (i.e. a plan) for another system (e.g. a linear accelerator) to deliver radiation to a patient. The dose calculation performed by Mobius3D uses a proprietary collapsed cone convolution superposition (CCCS) algorithm.
Mobius3D also performs dose delivery quality assurance for radiation treatment plans by using the measured data recorded in a linear accelerator's delivery log files to calculate a delivered dose. This is presented to the end user in a software component of Mobius3D called MobiusFX. The MobiusFX component is available to users through licensing as an add-on to the core Mobius3D software features.
Mobius3D performs quality assurance of a patient's alignment and anatomy analysis. This analysis is based on comparison of Cone Beam Computed Tomography (CBCT) images taken immediately before treatment to the images used for treatment planning, which are typically acquired using standard Computed Tomography (CT). This analysis is presented to the end user in an add-on software module within Mobius3D called CBCT Checks.
This document is a 510(k) premarket notification for the Mobius3D v2.2 software, which is used for quality assurance in radiation therapy. The submission focuses on demonstrating substantial equivalence to a predicate device (Mobius3D v2.0.0).
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance:
The document briefly mentions "software verification and validation" and states, "The non-clinical data support the safety of the device and the software verification and validation demonstrate that subject device should perform as intended in the specified use conditions." However, a specific table outlining acceptance criteria and reported device performance metrics is NOT provided in the given text. This information would typically be in a separate section of the 510(k) submission, not in the provided summary.
The document implicitly refers to performance related to "dose calculation verifications" and "dose delivery quality assurance" and "patient alignment and anatomy analysis," but no quantitative performance metrics or acceptance thresholds are given.
2. Sample size used for the test set and the data provenance:
The document states, "No animal studies or clinical tests have been included with this pre-market submission." This indicates that the safety and effectiveness determination is based on non-clinical data, likely software verification and validation activities. Since no clinical tests were performed, there is no "test set" in the traditional sense of patient data. Therefore, questions about sample size and data provenance (country of origin, retrospective/prospective) are not applicable to this specific submission as described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no clinical or human-in-the-loop tests were performed with a test set requiring ground truth, this information is not applicable and not provided in the document. The "ground truth" for a software QA tool like Mobius3D would likely be based on established physics principles, dose calculation standards, and comparisons to known accurate systems or phantoms.
4. Adjudication method for the test set:
Not applicable, as no external test set requiring human adjudication was used for 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 MRMC study was done. The document explicitly states, "No animal studies or clinical tests have been included with this pre-market submission." Mobius3D is described as an analysis tool for quality assurance, not a diagnostic AI system intended to assist human readers in image interpretation. Therefore, a MRMC study investigating human reader improvement with AI assistance is not relevant to the scope of this device as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
While the document doesn't explicitly use the term "standalone performance study," the entire submission suggests an algorithm-only (or software-only) performance evaluation as the basis for substantial equivalence. The "software verification and validation" (V&V) would have evaluated the Mobius3D algorithm's accuracy in dose calculations and analysis functions against expected outputs, likely using simulated data, phantom data, or comparisons to established (predicate) systems.
The changes mentioned, such as "Dose Calculation Reimplemented in C++," would have necessitated thorough verification of the reimplemented algorithm's accuracy as a standalone component.
7. The type of ground truth used:
Given the nature of the device (a quality assurance tool for radiation dose calculation and patient alignment analysis) and the absence of clinical studies, the "ground truth" for the software's performance would likely be established through:
- Physics-based models and established dosimetry principles: For dose calculation verification, the ground truth would be the theoretically correct dose distribution for specific radiation fields and patient geometries.
- Phantom measurements and comparisons: Physical phantoms with known properties would be irradiated, and the measured dose (using ion chambers or film) would serve as a ground truth for comparison with the software's calculations.
- Comparison to predicate device performance: The submission directly compares Mobius3D v2.2 to Mobius3D v2.0.0, implying that the performance of the predicate serves as a benchmark for substantial equivalence.
- Known image registration accuracy standards: For patient alignment and anatomy analysis, the ground truth would relate to the accuracy of image registration algorithms against known transformations or expertly aligned images.
The document does not explicitly state the type of ground truth used, but it can be inferred from the device's function.
8. The sample size for the training set:
This is not applicable and not provided. Mobius3D, as described, performs dose calculations and analysis using a proprietary collapsed cone convolution superposition (CCCS) algorithm and image processing techniques. It is not described as a machine learning/AI model that requires a "training set" in the context of supervised learning from a dataset of clinical cases (e.g., for image classification or segmentation). The software's capabilities are based on deterministic algorithms and physics models, not trained on a large dataset of patient outcomes or expert annotations.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" in the context of supervised machine learning for this device.
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Varian Medical Systems, Inc Peter Coronado Sr. Director, Regulatory Affairs 3100 Hansen Way PALO ALTO, CA 94304
July 31, 2019
Re: K191761
Trade/Device Name: Mobius3D Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 28, 2019 Received: July 1, 2019
Dear Mr. Peter 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. 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
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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 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 mediation-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 M. 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
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Indications for Use
510(k) Number (if known) K191761
Device Name Mobius3D v2.2
Indications for Use (Describe)
Mobius3D software is used for quality assurance, treatment plan verification, and patient alignment and anatomy analysis in radiation therapy. It calculates radiation dose three-dimensionally in a representation of a patient or a phantom. The calculation is based on read-in treatment plans that are initially calculated by a treatment planning system and may additionally be based on external measurements of radiation fields from other sources such as linac delivery log data. Patient alignment and anatomy analysis is based on read-in treatment planning images (such as computed tomography) and read-in daily treatment images (such as registered cone beam computed tomography).
Mobius3D is not a treatment planning system. It is only to be used by trained radiation oncology personnel as a quality assurance tool.
| 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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Image /page/3/Picture/0 description: The image shows the word "varian" in a bold, sans-serif font. The letters are all lowercase and evenly spaced. The word is likely a logo or brand name.
Varian Medical Systems, Inc Corporate Headquarters 3100 Hansen Way Palo Alto, CA 94304-1038
Telephone: 1.650.493.4000 Toll Free: 800.544.4636 www.varian.com
Premarket Notification 510(k) Summary
As required by 21 CFR 807.92
Special 510(k) Submission for Mobius3D v2.2
| Submitter's Name | Varian Medical Systems |
|---|---|
| 3100 Hansen Way, m/s E110 | |
| Palo Alto CA 94304 | |
| Contact Name: Peter J. Coronado | |
| Phone: 650/424.6320 | |
| Fax: 650/646.9200 | |
| Date: June 2019 | |
| Proprietary Name | Mobius3D |
| Classification Name | Accelerator, Linear, Medical |
| 21 CFR 892.5050 | |
| Class II | |
| Product Code: IYE | |
| Common/Usual Name | Mobius3D |
| Predicate Devices | Mobius3D (v2.0.0) K153014 |
| Indications for Use | Mobius3D software is used for quality assurance, treatment plan |
| verification, and patient alignment and anatomy analysis in radiation | |
| therapy. It calculates radiation dose three-dimensionally in a | |
| representation of a patient or a phantom. The calculation is based on | |
| read-in treatment plans that are initially calculated by a treatment | |
| planning system and may additionally be based on external | |
| measurements of radiation fields from other sources such as linac | |
| delivery log data. Patient alignment and anatomy analysis is based on | |
| read-in treatment planning images (such as computed tomography) and | |
| read-in daily treatment images (such as registered cone beam computed | |
| tomography). | |
| Mobius3D is not a treatment planning system. It is only to be used by | |
| trained radiation oncology personnel as a quality assurance tool. | |
| Device Description | Mobius3D (v. 2.2) is a software product used within a radiation therapyclinic for quality assurance and treatment plan verification. It is importantto note that while Mobius3D operates in the field of radiation therapy, itis neither a radiation delivery device (e.g. a linear accelerator), nor is it atreatment planning system (TPS). Mobius3D cannot design or transmitinstructions to a delivery device, nor does it control any other medicaldevice. Mobius3D is an analysis tool meant solely for quality assurance(QA) purposeswhen used by trained medical professionals. Being a software-only QAtool, Mobius3D never comes into contact with patients. |
| Mobius3D performs dose calculation verifications for radiation treatmentplans by doing an independent calculation of radiation dose. Radiationdose is initially calculated by a treatment planning system (TPS), which isa software tool that develops a detailed set of instructions (i.e. a plan) foranother system (e.g. a linear accelerator) to deliver radiation to a patient.The dose calculation performed by Mobius3D uses a proprietarycollapsed cone convolution superposition (CCCS) algorithm. | |
| Mobius3D also performs dose delivery quality assurance for radiationtreatment plans by using the measured data recorded in a linearaccelerator's delivery log files to calculate a delivered dose. This ispresented to the end user in a software component of Mobius3D calledMobiusFX. The MobiusFX component is available to users throughlicensing as an add-on to the core Mobius3D software features. | |
| Mobius3D performs quality assurance of a patient's alignment andanatomy analysis. This analysis is based on comparison of Cone BeamComputed Tomography (CBCT) images taken immediately beforetreatment to the images used for treatment planning, which are typicallyacquired using standard Computed Tomography (CT). This analysis ispresented to the end user in an add-on software module withinMobius3D called CBCT Checks. |
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varıan
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Device Comparison and Technological Characteristics
The significant changes compared with the predicate device are as follows:
-
- Support for Varian Halcyon Added
-
- Dose Calculation Reimplemented in C
The other modifications to the software device were considered to be non-significant changes. The complete list of changes are in the Summary of Testing for Changed or New Features and also addressed in the device comparison table in the Executive Summary and Substantial Equivalence Discussion.
Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Software verification and validation was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern.
The subject device conforms in whole or in part with the following standards:
- IEC 62304:2006, Medical Device Software Software Life Cycle Processes
- IEC 62366-1:2015, Medical Devices Part 1: Application of Usability Engineering to Medical Devices
- IEC 61217:2011, Radiotherapy Equipment Coordinates, Movements, and Scales
No animal studies or clinical tests have been included with this pre-market submission.
Conclusions
The non-clinical data support the safety of the device and the software verification and validation demonstrate that subject device should perform as intended in the specified use conditions. Varian considers Mobius3D v2.2 to be safe and effective and to perform as well or better than the predicate device.
§ 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.