(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.
§ 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.