(94 days)
Treatment plan verification System by double Monitor Units calculation and in vivo verifications management.
MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets.
It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions.
MU2net is dedicated to be used by high qualified professionals in medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.
MU2net is a standalone software designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems.
MU2net is also designed to manage in vivo measurements performed by skin dose detectors (diode in vivo dosimetry).
The DOSIsoft SA MU2net device is a quality assurance software designed to verify conventional and IMRT treatment plans and manage in vivo measurements during patient treatment. The provided document, a 510(k) Premarket Notification Summary, outlines the acceptance criteria and the study that proves the device meets these criteria.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes MU2net as a "Major Level of Concern" software, requiring robust testing. While it does not provide a specific table of numerical acceptance criteria with corresponding performance metrics (e.g., accuracy percentages or error margins), it generally states that the device meets safety and effectiveness requirements. The performance is assessed through various testing types.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Demonstrated through performance, functional, and algorithmic testing, risk management assessment, and validation activities under clinically representative conditions. MU2net meets user needs and intended use requirements. |
| Substantial Equivalence | The intended use, clinical, and technical characteristics (principles of operation, functionalities, and critical performances) are the same as for the predicate device IMSure QA Software (K031975). Differences in functional features do not significantly affect safety or effectiveness. |
| Compliance with Regulations | Designed and documented in accordance with FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." |
| Accuracy of MU/Dose Calculation | Based on "formalism booklet 3 - Monitor Unit Calculation for High Energy Photon Beams from ESTRO and Report 12 from Netherlands Commission on Radiation Dosimetry (NCS)." Inspired by J. H. Kung et al. "A monitor unit verification calculation in intensity modulated radiotherapy as a dosimetry quality assurance." (Medical Physics 2000 October; 27(10):2226-30). No specific numerical accuracy given. |
| In vivo Measurement Management | Software designed to manage in vivo measurements performed by skin dose detectors (diode in vivo dosimetry), with automatic or manual import of detector measurements. No specific performance metrics given. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly mentions "clinically representative conditions" for validation activities.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide details on the number of experts used to establish ground truth for the test set or their specific qualifications (e.g., radiologists with X years of experience). It states that the device is "dedicated to be used by high qualified professionals in medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning," implying that such professionals would be involved in, or validate, the ground truth.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it report an effect size of how much human readers improve with AI vs. without AI assistance. The focus of the submission is on standalone software performance and its equivalence to a predicate device, rather than human-in-the-loop performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone study was done. The device, MU2net, is described as a "standalone software quality control system" and its performance testing focuses on the algorithm's capabilities. The comparative assessment with the predicate device (IMSure QA Software) also centers on the technological characteristics and performance of the software itself.
7. The Type of Ground Truth Used:
The type of ground truth used is inferred from the device's function as a secondary monitor unit (MU) or dose calculation system and in vivo measurement manager. The "ground truth" would be established by:
- Established Physics Formalisms and Reports: The calculation algorithm is "Commissioning based on formalism booklet3 - Monitor Unit Calculation for High Energy Photon Beams from ESTRO and Report 12 from Netherlands Commission on Radiation Dosimetry (NCS)." This implies an established and validated theoretical framework serves as a ground truth for calculations.
- Published Research: Inspired by J. H. Kung et al. "A monitor unit verification calculation in intensity modulated radiotherapy as a dosimetry quality assurance" Medical Physics 2000 October; 27(10):2226-30, suggesting that published, peer-reviewed methods contribute to the ground truth.
- Measured Physical Beam Data: The device uses "measured physical beam data" for dose calculation and "Measured, tabular database stored" for physics data, indicating that real-world physical measurements form a part of the ground truth for calibration and verification.
- In vivo Detector Measurements: For the in vivo verification component, the "Import in vivo dose data" and the management of "detector measurements" would rely on the readings from skin dose detectors as the ground truth for actual patient dose.
8. The Sample Size for the Training Set:
The document does not provide information regarding a specific "training set" sample size. As a "standalone software quality control system" for secondary calculations and in vivo measurement management, it's more likely based on established physics models and calibrated parameters rather than a machine learning model that requires a discrete training set in the typical sense. If internal models are used, the architecture and training data are not described.
9. How the Ground Truth for the Training Set Was Established:
Given the nature of the device as a calculative and management tool based on physics principles, the concept of a "training set" and its ground truth is not explicitly addressed in the document in the typical machine learning context. Instead, the algorithm's basis is rooted in:
- Physics Formalisms: ESTRO and NCS reports.
- Scientific Literature: J.H. Kung et al.'s publication.
- Measured Physical Data: Calibration using measured beam data from linear accelerators.
These form the underlying "ground truth" upon which the software's algorithms are built and validated, rather than a specific labeled dataset used for training an AI model.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
October 24, 2019
DOSIsoft SA % Mr. Luc Diot Quality Director 45/47, Avenue Carnot 94230 Cachan FRANCE
Re: K191944
Trade/Device Name: MU2net Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: July 10, 2019 Received: July 30, 2019
Dear Mr. Diot:
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
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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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
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
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Indications for Use
510(k) Number (if known) K191944
Device Name MU2net
Indications for Use (Describe)
Treatment plan verification System by double Monitor Units calculation and in vivo verifications management.
MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets.
It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions.
MU2net is dedicated to be used by high qualified professionals in medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the word "DOSI" in bold, black font, followed by a blue butterfly outline, and the word "soft" in a thin, black font. The butterfly is positioned between the two words, creating a logo-like appearance. The overall design is clean and simple, with a focus on the text and the butterfly symbol.
Image /page/3/Picture/1 description: The image is a logo for ISO certification. The logo is a blue circle with the word "iSO" in white letters in the center. There are two red arrows on either side of the word "iSO", pointing towards it. The number "73485" is printed at the bottom of the circle.
Premarket Notification 510(k) Summary
[as required by 21 CFR 807.92]
510(k) Summary
-
- Date the Summary was prepared: 2019-07-10
2. Submitter:
| Company Name: | DOSIsoft SA |
|---|---|
| Address: | 45-47, Avenue Carnot94230 CACHAN – France |
| Phone No.: | +33 1 41 24 26 26 |
| Fax No.: | +33 1 41 24 26 28 |
| Contact Name: | Mr. Marc USZYNSKI |
3. Device Information:
| Proprietary Name: | MU2net |
|---|---|
| Trade Names: | MU2net |
| Common Name: | Standalone software quality control system |
| Classification Name: | Medical charged-particle radiation therapy system(21 CFR 892.5050, Class II, Product Code IYE) |
4. Predicate Device:
K031975 - IMSure OA Software - Standard Imaging, Inc. (Prodigm, Inc.)
Executive Summary
5. Product Description:
MU2net is a standalone software designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems.
MU2net is also designed to manage in vivo measurements performed by skin dose detectors (diode in vivo dosimetry).
6. Intended Use and User profiles:
Treatment plan verification System by double Monitor Units calculation and in vivo verifications management.
MU2net is indicated for use as a quality assurance software to verify conventional and IMRT treatment plans provided by Radiotherapy Treatment Planning Systems and transferred as DICOM RT Plan data sets.
It is also indicated for use as a quality assurance software to manage in vivo measurements performed during the patient treatment fractions.
MU2net is dedicated to be used by high qualified professionals in medical oncology and/or medical physics such as Radiation-Oncologists, Medical Physicists and Technicians performing treatment planning.
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Image /page/4/Picture/0 description: The image shows the word "DOSI" in a bold, serif font, followed by a blue butterfly-shaped design with red arrows pointing towards it. The word "soft" is written in a thin, sans-serif font to the right of the butterfly. The text and butterfly design appear to be part of a logo or branding element.
Image /page/4/Picture/1 description: The image shows a blue circular logo with the text "iSO" in the center. The text "CERTIFIED" is written in a smaller font size above the "iSO" text, and the number "73485" is written below it. There are two small red arrows pointing towards the "iSO" text from the left and right sides.
7. Technological Characteristics:
The table below compares the technological characteristics and the features of MU2net and its predicate IMSure QA Software.
| Device name | IMSure QA Software(predicate) | |
|---|---|---|
| (this submission) | ||
| 510(k) number | This filing | K031975 |
| Company | DOSIsoft SA | Standard Imaging, Inc. (Prodigm, Inc.) |
| Intended use | is intended to be used as a qualityassurance software for secondarymonitor-unit (MU) or secondary dosecomputations from DICOM RT Plansprovided by TPS.It is also intended for in vivo dosemeasurements management. | Independent dose and fluence mapverification software for IntensityModulated Radiation Therapy based onLinear accelerator plans containing multi-leaf collimator leaf sequence data andfluence maps from primary IMRTtreatment planning systems.Independent dose computation softwarefor standard, simple geometry radiationtherapy treatment planning andverification of monitor units based onLinear Accelerator parameters andphysician prescribed dose information. |
| Indication foruse | is indicated for use as a qualityassurance software to verify conventionaland IMRT (static or rotational) treatmentplans provided by RadiotherapyTreatment Planning Systems andtransferred as DICOM RT Plan data sets.It is also indicated for use as a qualityassurance software to manage in vivomeasurements performed during patienttreatment fraction. | IMSure is indicated for use as a qualityassurance tool to verify IMRT treatmentplans developed on any radiation therapytreatment planning system with theappropriate transfer format. IMSure willalso perform primary monitor unitcalculations from measured physics datafor plans of known geometry. |
| Targetpopulation | is used to validate a plan for anypopulation (child, adult and elderlypeople) having a diagnosed cancer andfollowing an External Beam Radiotherapy. | Same |
| Anatomicalsites | is used for human medical field. is usedto validate a plan for any tumor sites. | Same |
| Where used | is installed in medical facilities. | Same |
| Human factors | It is used by qualified users such asradiation oncologists, medical physicistsand medical dosimetrists. | Same |
| Design | Dose computations are performed at localworkstation. Multiple simultaneous dosecalculations. | Same |
| Performances | ||
| Algorithm - mapverification | No | Single Source model |
| Dose / MUcalculationAlgorithm | Commissioning based on formalismbooklet3 - Monitor Unit Calculation forHigh Energy Photon Beams from ESTROand Report 12 from NetherlandsCommission on Radiation Dosimetry(NCS).Inspired from J. H. Kung and al. "Amonitor unit verification calculation inintensity modulated radiotherapy as adosimetry quality assurance" Medical | 3DCRT: Khan (classical)IMRT/VMAT: Single Source model,Clarkson scatter algorithm based onStanford University method |
| DOSISOFT SA45/47, avenue Carnot94230 Cachan - France | +33 (0)1 41 24 26 26+33 (0)1 41 24 26 28 | info@dosisoft.comwww.dosisoft.com | RCS Créteil 443 195 433 | Page 2/4 |
|---|---|---|---|---|
| -------------------------------------------------------------- | ------------------------------------------------------ | --------------------------------------- | ------------------------- | ---------- |
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Image /page/5/Picture/0 description: The image shows the word "DOSI" in large, bold, black font, followed by a blue butterfly-shaped design with red arrows pointing towards it. The word "soft" is written in a smaller, thinner, black font to the right of the butterfly. The text and butterfly design together form a logo or brand name.
Image /page/5/Picture/1 description: The image is a blue and white circular logo that says "CERTIFIED" at the top and has the letters "iSO" in the center. There are two red arrows on either side of the letters. The number "73485" is at the bottom of the circle.
| Device name | (this submission) | IMSure QA Software (predicate) |
|---|---|---|
| Physics 2000 October; 27(10):2226-30. | ||
| Patient Geometry Specifications | Dose computing: Large parallelepipedic water phantom.Calculation point position and depth:external/internal/support outlines andelectron density from DICOM RT StructureSet for VMAT plans | Two dimensional, graphical user interface based |
| Machines supported | Commercially available LinearAccelerators.Supports MR-Linacs. | Commercially available LinearAccelerators. |
| Calculation point for MU calculations | Off-Axis and depth specified distancesrequired for dose calculation (dose pointcoordinates) using measured physicalbeam data.Dose verification is performed using a listof points of interest given in the RT Planfile. | Same |
| Physics Data | Measured, tabular database stored. | Measured, tabular database stored,multiple linear allowed. |
| Scatter table | Processed | Measured. |
| Import plan data | DICOM RT | DICOM RTRTP link |
| Supported treatment technics | 3D CRT, IMRT, VMAT | Same |
| TPS supported | DOSIsoft/Isogray,Varian/Eclipse,Philips/Pinnacle,Elekta/Xio, MonacoNucletron/OncentraRaySearch/RayStation | Same |
| Database | Provides easy access to patientinformation allowing you to verify, changecalculations or change the status of theplan. | Provides easy access to patientinformation allowing you to verify, changeor copy calculations. |
| Gives multiple user access to all patientcalculation information using a web-basedinterface. | Gives multiple user access to all patientcalculation information from a networkserver. | |
| Import in vivo dose data | Automatic or manual import of detectormeasurements. | The software allows a simple interface toenter the collected data and computes theexpected diode reading for eachtreatment field. |
| Dose calibration method(s) | Apply to all beams with isocentric or fixedSSD calibration | Isocentric or fixed SSD calibrationdistance. |
| Export data | Results can be printed out or saved asPortable Document Format (PDF) files.The original DICOM RT Plan provided bythe TPS is never modified and can beforwarded to the R&V system. | Paper documentationDICOM RTRTP Link |
| Cybersecurity | Secure login with layered authorizationmodel. | Secure login with layered authorizationmodel. |
| Traceability | The user can see the chronologicalaccount of events from the file import tothe current status. | Not available |
| Review interface | Web based interface | Windows based interface |
| Operating system | Linux operating system | Microsoft Windows operating system |
DOSISOFT SA 45/47, avenue Carnot 94230 Cachan - France
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Image /page/6/Picture/0 description: The image shows the word "DOSIsoft" in a stylized font. The first four letters, "DOSI", are in a bold, serif font, while the "soft" part of the word is in a thinner, sans-serif font. Between the "I" and "soft" is a blue butterfly-shaped design, which appears to be part of the logo.
8. Performance Testing - Bench:
MU2net was designed and documented in accordance with the recommandations of FDA "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" for software devices identified as Major Level of Concern.
MU2net was submitted to performance, functional and algorithmic testing, risk management assessment and validation activities under clinically representative conditions.
The results of performance, functional and algorithmic testing, risk management and validation activities under clinically representative conditions demonstrate the safety and effectiveness of MU2net.
MU2net meets the requirements of the device, its user needs and intended use, which are demonstrated to be substantially equivalent to those of the predicate device.
9. Conclusions
The substantial equivalence discussion sustains that MU2net intended use, clinical and technical (principles of operation, functionalities and critical performances) characteristics are the same as for the predicate device IMSure OA Software legally marketed in the U.S. (K031975).
The differences on some functional features do not significantly affect, or may not significantly affect, safety or effectiveness.
The results of verification and validation activities demonstrate the safety and effectiveness of MU2net. MU2net meets the requirements of the device, its user needs and intended use, which are demonstrated to be substantially equivalent to those of the predicate device.
In summary, DOSIsoft therefore considers that, in its opinion, MU2net is substantially equivalent to and is at least as safe and effective as the predicate device.
- France
+33 (0)1 41 24 26 26 24 26 28
RCS Créteil 443 195 433
Page 4/4
§ 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.