(58 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) and again when Dynamic Conformal Arc planning was added (K110730). The Monaco system accepts patient diagnostic 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 beam modifiers 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 prescription is then selected, one that maximizes dose to the target volume while minimizing dose to surrounding healthy volumes.
Acceptance Criteria and Study for Monaco RTP System
The Monaco RTP System is a radiation treatment planning system. The provided document focuses on demonstrating its substantial equivalence to previously cleared devices rather than defining specific performance acceptance criteria against a new clinical standard. The "acceptance criteria" in this context are implicitly that the device performs comparably to its predicate devices for the stated intended uses and technological characteristics.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the 510(k) submission, the "acceptance criteria" are not explicit numerical targets but rather a demonstration of substantial equivalence to predicate devices across various features and functionalities. The "reported device performance" is the assertion that the Monaco RTP System with new features meets or exceeds these characteristics.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Monaco RTP System (K132971) Performance |
|---|---|
| Intended Use & Indications for Use: | |
| - Contouring capabilities | Yes |
| - Dose Calculation capabilities | Yes |
| - Plan Optimization capabilities | Yes |
| - Image Manipulation & Fusion capabilities | Yes |
| - CT Simulation capabilities | Yes |
| - QA/Plan Review capabilities | Yes |
| - Brachytherapy support | No (Consistent with predicate Monaco K110730 and ERGO++ K080601) |
| Technological Characteristics: | |
| - Dose Calculation Algorithms | Monte Carlo (electron & photon), Collapsed Cone (photon), Pencil Beam (optimization only) - Expanded from predicate Monaco (K110730) which only had Monte Carlo (photon) & Pencil Beam. |
| - Calculation and display of standardized uptake value for contouring on PET images | Yes (New feature, aligned with Eclipse TPS K102011) |
| - Local Biological Measure Optimization | Yes (Consistent with predicate Monaco K110730 and Eclipse TPS K102011) |
| - MLC Support | Yes |
| - Support for Other Treatment Aids | Yes (New feature, aligned with ERGO++ K080601, Eclipse TPS K102011, Oncentra K121448) |
| - Support for Dynamic Delivery Methods | Yes |
| - Operating System | Windows (Consistent with predicate Monaco K110730, Eclipse TPS K102011, Oncentra K121448) |
| - DICOM RT Support | Yes |
| - Modalities Supported: Full RTP Workflow | Photon & Electron (Expanded from predicate Monaco K110730 which was Photon Only, aligned with Eclipse TPS K102011, Oncentra K121448) |
| - Modalities Supported: Partial Workflow* (e.g., image fusion, contouring, simulation) | Electron, Photon, Proton (Expanded from predicate Monaco K110730 which was Photon, Proton, Electron, and aligned with Eclipse TPS K102011, Oncentra K121448) |
| - Can be used for stereotactic treatment planning | Yes |
| - Stereotactic Localization | No (Consistent with predicate Monaco K110730, aligned with Oncentra K121448) |
| - Support for Cone-Based Stereotactic | Yes (New feature, aligned with ERGO++ K080601, Eclipse TPS K102011) |
| Safety and Effectiveness: | |
| - Risk Mitigation functions as intended | Passed testing demonstrating that risk mitigations function as intended. |
| - Continued safety and effectiveness of existing functionality (regression testing) | Passed regression tests. |
| - Accuracy of dose calculation functions | Validated through algorithm testing using a simulated clinical setup. |
| - System working as designed for new product functionality (verification tests > 500) | Verification tests for new product functionality were written and executed, and the system "passed testing and was deemed safe and effective for its intended use." (Implied successful completion of all >500 tests, including those for new features). |
2. Sample Size Used for the Test Set and the Data Provenance
The document states: "Validation testing involved simulated clinical workflows, and algorithm testing, described in detail in section 20, which validated the accuracy of dose calculation functions using a simulated clinical setup."
- Sample Size for Test Set: Not explicitly stated. The phrase "simulated clinical workflows, and algorithm testing" suggests a variety of test cases, but the exact number or type of "simulated clinical setups" or specific test patients/scenarios is not quantified in the provided text.
- Data Provenance: The data is generated from "simulated clinical workflows" and "algorithm testing using a simulated clinical setup." This indicates the data is synthetic or derived from controlled test environments, not from real patient data. There is no mention of country of origin as it's not real-world data. The nature of the testing is retrospective in the sense that it's against predefined test cases and expected outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. However, the document notes that "Dosimetrist or Medical Physicist" are the users who create treatment plans and qualified clinicians review and approve them. It is implied that any "ground truth" for simulated scenarios would be established by similarly qualified professionals or based on established physics principles and industry standards.
4. Adjudication Method for the Test Set
Not specified. The testing involved "verification tests" and "algorithm testing" against "simulated clinical workflows" and "simulated clinical setup." This implies that the correctness of the output was compared against expected results, likely determined by established physics models or known solutions for the simulations, rather than requiring expert adjudication of discrepancies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document explicitly states: "Clinical trials were not performed as part of the development of this product. Clinical testing on patients is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk." This confirms that no human reader studies (MRMC or otherwise) were conducted.
- Effect Size of human readers improvement with AI vs without AI assistance: Not applicable, as no MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes. The validation testing included "algorithm testing, described in detail in section 20, which validated the accuracy of dose calculation functions using a simulated clinical setup." This specifically refers to the performance of the algorithm itself in dose calculation. Additionally, "Over 500 test procedures were executed, including tests to verify requirements for new product functionality" and "regression tests," which would inherently involve evaluating the algorithm's output against expected results in a standalone manner.
7. The Type of Ground Truth Used
The ground truth for the algorithm and verification testing appears to be based on:
- Established physics principles and models: Given that the device calculates radiation dose, the ground truth for dose calculation functions would be derived from known physics equations and simulated or theoretical benchmarks.
- Engineering specifications and requirements: The "over 500 test procedures" and "requirements for new product functionality" suggest that many ground truths were the expected behavior and output defined by the device's design specifications.
- Expected outcomes from simulated clinical setups/workflows: This implies a comparison against a "correct" or "ideal" treatment plan result for a given simulated patient scenario.
8. The Sample Size for the Training Set
The document does not mention a "training set" in the context of machine learning. The Monaco RTP System is a software system based on physics models and algorithms for radiation treatment planning, not a system that is "trained" on a dataset in the typical machine learning sense. Therefore, this information is not applicable.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no mention of a training set for machine learning. The "ground truth" for the device's underlying physics models and algorithms would be established through principles of radiation physics, mathematical derivations, and prior validation of these computational methods.
§ 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.