(56 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 and electron treatment plans and displays, on-screen 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
Monaco is a radiation treatment planning system that first received FDA clearance in 2007 (K071938). The modified system received clearance in 2009, when Volumetric Modulated Arc Therapy (VMAT) planning capability was added (K091179), again when Dynamic Conformal Arc planning was added (K110730), and electron planning, support for stereotactic cones, and SUV calculation were added (K132971). Specialty image creation was added in 2015 (K151233), and adaptive planning and dose calculation in the presence of a magnetic field (e.g., MR-Linac) was added in 2018 (K183037). A 510(k) was filed in 2017 for the addition of carbon ion planning. The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans. Monaco's carbon ion planning functionality remains licensed off and inaccessible to US users.
The Monaco system accepts patient imaging data and "source" dosimetry data 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 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. The Monaco system then produces a display of radiation dose distribution within the patient, indicating doses to the target volume and surrounding structures. The "best" plan satisfying the clinican prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
Here's a summary of the acceptance criteria and study information for the Monaco RTP System based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Functional/Technological) | Reported Device Performance (Monaco with new features) |
|---|---|
| Contouring | Yes |
| Dose Calculation | Yes |
| Plan Optimization | Yes |
| Image Manipulation & Fusion | Yes |
| CT Simulation | Yes |
| QA/Plan Review | Yes |
| Dose Calculation Algorithms | Monte Carlo (electron & photon), Collapsed Cone (photon), Pencil Beam (optimization only), GPUMCD for MR-linac |
| Calculates dose for MR-Linac (including magnetic field, coils & cryostat) | Yes |
| Adaptive therapy features | Yes |
| Calculation and display of standardized uptake value | Yes |
| Local Biological Measure Optimization | Yes |
| Support for various treatment aids | Yes |
| Support for Dynamic Delivery Methods | Yes |
| Operating System | Windows |
| DICOM RT Support | Yes |
| Modalities Supported: Full RTP workflow (Photon, Electron) | Photon, Electron |
| Modalities Supported: Partial workflow (Photon, Electron, Proton) | Photon, Electron, Proton |
| Support for brachytherapy | No |
| Interoperable with OIS system | Yes, including support for prescribed relative offset (PRO) |
| Beam modeling | Beam modeling is performed by Elekta personnel. New standardized beam models are provided for some Elekta linac energy options, and absolute dose calibration will be performed by users. |
| Conformity to pre-defined pass/fail criteria (equivalent to K183037) | Confirmed. The product was deemed substantially equivalent and fit for clinical use. |
| Functionality as designed, including new features, risk mitigations, and existing features | Verified by over 600 test procedures. |
Study Information:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of cases or patients. The validation testing involved "simulated clinical workflows using actual patient data, such as patient images."
- Data Provenance: "Actual patient data, such as patient images." The country of origin is not specified, but the context of an FDA submission implies a focus on data relevant to the U.S. market, though not exclusively. The study was retrospective in the sense that it used pre-existing "actual patient data."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The adjudication of ground truth for the test set is not explicitly detailed.
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Adjudication method for the test set:
- The document states that plans are "reviewed and approved by qualified clinicians and may be subject to quality assurance practices before treatment actually takes place." However, for the specific test set used in validation, the adjudication method (e.g., 2+1, 3+1 consensus) is not explicitly described. The testing involved "pre-defined pass/fail criteria" that were "equivalent to that of the predicate, K183037."
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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:
- A multi-reader multi-case (MRMC) comparative effectiveness study was not performed. The device is a treatment planning system, not an AI-assisted diagnostic tool for human readers in the traditional sense discussed in MRMC studies.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the primary validation was effectively a standalone performance evaluation of the software. The document states: "Verification tests were written and executed to ensure that the system is working as designed. Over 600 test procedures were executed, including tests to verify requirements for new product functionality, tests to ensure that risk mitigations function as intended, and regression tests to ensure continued safety and effectiveness of existing functionality." This describes an algorithm-only evaluation against predefined criteria.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the test set verification was based on pre-defined pass/fail criteria and ensuring the system's calculations and functionality matched expectations established by the predicate device (K183037) and internal Elekta requirements. It also relied on "simulated clinical workflows using actual patient data" to ensure the system produced expected dose distributions and plan outputs. It is not framed as comparing to pathology or long-term outcomes data, but rather the accurate computation and display of dose distributions as per established physics and clinical planning principles.
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The sample size for the training set:
- The document does not specify a distinct "training set" for the Monaco RTP System. As a radiation treatment planning system, it relies on physics models and algorithms rather than machine learning models that typically require a training set in the AI sense. The development likely involved extensive testing and calibration against known physics principles and clinical data, which is distinct from a machine learning training set.
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How the ground truth for the training set was established:
- Since a distinct "training set" in the machine learning context is not mentioned, the concept of establishing ground truth for it is not applicable based on the provided text. The accuracy of the system is established through rigorous verification against physics models, calculations, and clinical expectations, rather than learning from a labeled training dataset.
§ 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.