(84 days)
The Monaco system is used to create treatment plans for any cancer patient for whom external beam intensity modulated radiation therapy (IMRT) has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two- or threedimensional radiation dose distributions within a patient for a given treatment plan setup.
The Monaco product line is intended for use in radiation treatment planning using generally accepted methods for contouring, image manipulation, simulation, image fusion, plan optimization and QA and plan review.
Monaco uses local biological measures for optimization to create intensity modulated radiation therapy (IMRT) plans using Multileaf Collimators. With the addition of VMAT planning capability, Monaco also allows users to creatment plans in which the devices that aim and shape the beam are in motion while the beam is on.
The provided text describes the Monaco RTP System - VMAT Option, a software used for radiation treatment planning. It states that "Clinical trials were not performed as part of the development of this product." Instead, "Clinically oriented validation test cases were written and executed in-house by Customer Support personnel in a simulated clinical environment. Algorithm testing was also performed by qualified Medical Physicists using measured data from clinical facilities."
However, the document does not provide:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set or data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication methods.
- Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
- Specific details on standalone algorithm performance.
- Type of ground truth used (beyond "measured data").
- Sample size for the training set.
- How ground truth for the training set was established.
Therefore,Based on the provided text, a comprehensive description of acceptance criteria and the study proving the device meets them cannot be fully constructed for many of the requested categories. The document explicitly states that "Clinical trials were not performed."
Here's what can be extracted and what is missing:
Acceptance Criteria and Study Details:
| Information Category | Details from K091179 |
|---|---|
| 1. Table of Acceptance Criteria and Reported Performance | Acceptance Criteria: Not explicitly stated as a table. The document mentions "Pass/fail requirements" for verification testing and that "Monaco with the VMAT option successfully passed both testing efforts and was deemed fit for clinical use." |
Reported Device Performance: The text states, "Monaco with the VMAT option successfully passed both testing efforts and was deemed fit for clinical use." No quantitative performance metrics (e.g., accuracy, precision, dose deviation thresholds) are provided in this summary. |
| 2. Sample size for test set and data provenance | Sample Size: Not specified. The document mentions "Clinically oriented validation test cases" and "measured data from clinical facilities" but does not give a number of cases or patients.
Data Provenance: "measured data from clinical facilities." Specific countries or retrospective/prospective nature are not mentioned. |
| 3. Number and qualifications of experts for ground truth | Number of Experts: Not specified.
Qualifications: "qualified Medical Physicists" performed algorithm testing. For clinically oriented validation, "Customer Support personnel in a simulated clinical environment" executed tests. No specific experience or board certifications are provided for either group. |
| 4. Adjudication method for the test set | Not documented. |
| 5. MRMC comparative effectiveness study | No. The document explicitly states: "Clinical trials were not performed as part of the development of this product." |
| 6. Standalone (algorithm only) performance study | Yes, to some extent. "Algorithm testing was also performed by qualified Medical Physicists using measured data from clinical facilities." This suggests an assessment of the algorithm's output against known measured data, which is a form of standalone performance evaluation. However, detailed results or metrics are not provided in this summary. |
| 7. Type of ground truth used | "Measured data from clinical facilities." This implies physical measurements of radiation dose distributions that the system's calculations were compared against. |
| 8. Sample size for the training set | Not applicable/Not specified. This is a radiation treatment planning system that calculates dose distributions, not a machine learning model that would typically have a "training set" in the conventional sense. The "algorithm" was developed, and then tested. |
| 9. How ground truth for the training set was established | Not applicable/Not specified (see point 8). |
Summary of Study (as described in the document):
The Monaco RTP System - VMAT Option underwent two main types of testing:
- Clinically oriented validation test cases: These were executed in-house by Customer Support personnel within a simulated clinical environment. The specific nature of these "test cases" (e.g., number of plans, complexity) is not detailed.
- Algorithm testing: This was performed by qualified Medical Physicists. The testing involved comparing the algorithm's outputs against "measured data from clinical facilities." The report states that "Test reports are included in section 20 of this submission," but these details are not provided in the summary.
Both testing efforts were successfully passed, leading the device to be deemed "fit for clinical use." Verification tests, with associated pass/fail requirements, were also conducted to ensure the system functioned as designed, and these were also successfully passed.
Crucially, no clinical trials involving human subjects were performed or deemed necessary for this premarket notification, as the manufacturer argued that "testing can be performed such that no human subjects are exposed to risk" and that clinical testing was "not advantageous in demonstrating substantial equivalence or safety and effectiveness." The device's safety and effectiveness were established through comparison to predicate devices and the non-clinical testing described above.
§ 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.