(33 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). Finally, specialty image creation was added in 2015 (K15123). 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 The 510(k) was withdrawn because there was no hardware cleared for the US market capable of delivering carbon ion plans.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.
The Monaco RTP System is a radiation treatment planning system. The provided text indicates that no clinical trials were performed. Instead, validation testing involved simulated clinical workflows using actual patient data, and algorithm testing verified the accuracy of the new dose calculation algorithm.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria (Pre-defined pass/fail criteria) | Reported Device Performance (Summary of Non-Clinical Testing) |
|---|---|
| Equivalent to predicate (K151233) | Demonstrated equivalent accuracy to the predicate device. |
| Conformity to the same pass/fail criteria as the predicate (K151233) | Monaco 5.40 was deemed substantially equivalent in safety and effectiveness. |
2. Sample size used for the test set and data provenance:
- Test Set Sample Size: The document mentions "actual patient data" was used for simulated clinical workflows and algorithm testing, but it does not specify the sample size of this patient data.
- Data Provenance: The document does not specify the country of origin. It indicates the data was "actual patient data," but does not state whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- The document states that "qualified clinicians" review and approve treatment plans and that the process "can be performed such that no human subjects are exposed to risk." This implies that the validation testing was based on expert consensus or established clinical standards rather than live patient outcomes. However, the number of experts and their specific qualifications are not specified.
4. Adjudication method for the test set:
- The document mentions that treatment plans are "reviewed and approved by qualified clinicians," and that a "flaw in the treatment plan [could] escape the notice of the qualified professionals." This suggests a review process by experts. However, a formal adjudication method (e.g., 2+1, 3+1) is not explicitly described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical trials were not performed as part of this product."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, a standalone component was done for algorithm testing. The document states: "Algorithm testing verified the accuracy of the new dose calculation algorithm in Monaco 5.40 using the same test methods as the predicate version of Monaco." This implies evaluation of the algorithm's performance independent of a human user.
7. The type of ground truth used:
- The ground truth appears to be based on established clinical standards and expert review/consensus rather than direct pathology or outcomes data from clinical trials. The document mentions "pre-defined pass/fail criteria" and validation against "simulated clinical workflows using actual patient data." The acceptance criteria focused on demonstrating "equivalent accuracy" to the predicate device, which would have its own established standards.
8. The sample size for the training set:
- The document does not specify a training set sample size. The focus of the provided text is on validation and verification testing of the already developed Monaco RTP system, which includes a new dose calculation algorithm. It does not describe the development or training phase of the algorithm itself.
9. How the ground truth for the training set was established:
- Since a training set is not explicitly mentioned and the document focuses on the validation of an existing system's new algorithm, the method for establishing ground truth for a hypothetical training set is not described.
§ 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.