(127 days)
The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy. The system calculates dose for photon, electron, and proton treatment plans and in hard-copy, two- or three-dimensional radiation dose distributions inside patients for given treatment plan set-ups.
The Monaco product line is intended for use in radiation treatment planning. It uses generally accepted methods for:
- contouring
- image manipulation
- simulation
- image fusion
- plan optimization
- QA and plan review
The Monaco RTP System accepts patient diagnostic imaging data from CT and MR scans, and source dosimetry data, typically from a linear accelerator. The system then permits the user to display and define (contour) the target volume to be treated and critical structures which must not receive above a certain level of radiation, on these diagnostic images. Based on the prescribed dose, the user, a Dosimetrist or Medical Physicist, can then create multiple treatment scenarios involving the number, position(s) and energy of radiation beams and the use of a beam modifier (MLC, block, etc.) between the source of radiation and the patient to shape the beam. Monaco RTP system then produces a display of radiation dose distribution within the patient, indicating not only doses to the target volume but to surrounding tissue and structures. The optimal plan satisfying the prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
The parameters of the plan are output for later reference and for inclusion in the patient file. Monaco planning methods and modalities:
- Intensity Modulated Radiation Treatment (IMRT) planning
- Electron, photon and proton treatment planning
- Planning for dynamic delivery methods (e.g. dMLC, dynamic conformal, Volumetric Modulated Arc Therapy (VMAT))
- Stereotactic planning and support of cone-based stereotactic
- 3D conformal planning
- Adaptive planning (e.g. for the Elekta Unity MR-Linac)
- Monaco basic systems tools, characteristics, and functions:
- Plan review tools
- Manual and automated contouring tools
- DICOM connectivity
- Windows operating system
- Simulation
- Support for a variety of beam modifiers (e.g. MLCs, blocks, etc.)
- Standardized uptake value (SUV)
- Specialty Image Creation (MIP, MinIP, and Avg)
- Monaco dose and Monitor Unit (MU) calculation:
- Dose calculation algorithms for electron, photon, proton planning
Monaco is programmed using C and C++ computer programming languages. Monaco runs on Windows operating system and off-the-shelf computer server/hardware.
The provided text is a 510(k) summary for the Monaco RTP System, an updated version of a previously cleared device. It largely focuses on demonstrating substantial equivalence to the predicate device and does not contain detailed acceptance criteria or a study proving the device meets them in the format requested. The document explicitly states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate device." Therefore, I cannot provide a table of acceptance criteria, reported device performance, or details about a clinical study.
However, based on the non-clinical performance testing described, here's what information can be extracted:
1. A table of acceptance criteria and the reported device performance:
Based on the provided text, specific numerical acceptance criteria and corresponding reported device performance values are not available. The document states that "Design verification and performance testing were carried out in accordance with design controls... against design and risk management requirements at sub-system, integration and system levels." It also mentions "Software verification testing was conducted and documented in accordance with FDA quidance 1 for devices that pose a major level of concern (Class C per IEC 62304)." However, the actual criteria for these verifications (e.g., specific error margins for dose calculation, response times for image manipulation) and the measured performance against those criteria are not detailed.
2. Sample size used for the test set and the data provenance:
- Sample size used for the test set: Not specified. The document mentions "sub-system, integration and system levels" testing, but no specific number of test cases or data sets are provided.
- Data provenance: Not specified. As no clinical studies were performed, the "data" would refer to test cases, models, or simulated data used in the non-clinical verification. The origin of this data is not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. Since no clinical studies or expert consensus activities are described for establishing ground truth on a test set, this information is not available.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None specified. No adjudication method is mentioned as there were no clinical studies.
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 comparative effectiveness study was conducted. The device is a Radiation Treatment Planning (RTP) system, not an AI-assisted diagnostic tool that would typically involve human readers in this context. The document explicitly states "No animal or clinical tests were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document describes "Design verification and performance testing" and focuses on the system's ability to calculate dose, perform image manipulation, optimization, etc., which implies a standalone performance evaluation of the software components. However, specific performance metrics for the algorithm only without any human interaction involved in setting up the plan or interpreting the output are not quantified. The mention of "Software verification testing" suggests an evaluation of the algorithm's correctness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical testing, the "ground truth" would likely be established through:
- Reference data/models: For dose calculations, comparison against established physics models, phantom measurements, or other validated dose calculation systems.
- Known input/output pairs: For software functionalities like image manipulation or contouring, where the expected output for a given input is pre-defined.
- Compliance with standards: The document lists several ISO and IEC standards (e.g., ISO 62083 for radiotherapy treatment planning systems), implying that meeting the requirements of these standards serves as a form of "ground truth" for safety and performance.
8. The sample size for the training set:
- Not applicable/Not specified. The document does not describe the device as employing machine learning or AI that would require a "training set" in the conventional sense for a diagnostic algorithm. It describes a physics-based dose calculation and treatment planning system.
9. How the ground truth for the training set was established:
- Not applicable. As no training set is described, there's no information on how its ground truth would be established.
In summary, the provided document is a 510(k) premarket notification for an updated Radiation Treatment Planning (RTP) system. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical verification and validation testing against design requirements and recognized standards, rather than providing details of a clinical study or specific quantitative acceptance criteria and performance data.
§ 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.