(80 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 three-dimensional radiation dose distributions within a patient for a given treatment plan set-up.
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.
The provided text describes the Monaco RTP System, a radiation treatment planning system, and its non-clinical testing for substantial equivalence. It does not contain information about clinical trials or the specific acceptance criteria and performance metrics typically found in studies involving AI performance for diagnosis or image interpretation.
Based on the provided text, here is an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table with specific quantitative acceptance criteria or detailed performance metrics. Instead, it states:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Verification Testing | "The verification testing performed on Monaco incorporated the same pass/fail criteria and the same algorithm accuracy requirements as those used to evaluate the XiO RTP System and the Focal Workstation." |
| Algorithm Testing | "Monaco successfully passed both verification and algorithm testing." |
| Clinical Use Fitness | "Monaco was deemed fit for clinical use." |
2. Sample Sizes Used for Test Set and Data Provenance:
The document explicitly states that clinical trials were not performed. Therefore, there isn't a "test set" in the traditional sense involving patient data for an effectiveness study.
- Test Set Sample Size: Not applicable, as no clinical test set was used for effectiveness.
- Data Provenance: Not applicable for effectiveness testing. However, for "On-site validation testing," it mentions "a small group of customers, using actual patient data." The origin of this patient data (country, retrospective/prospective) is not specified. This validation was not a formal clinical trial for effectiveness.
3. Number of Experts and Qualifications for Ground Truth:
- Number of Experts: Not specified.
- Qualifications of Experts: For the "on-site validation testing," it mentions "qualified clinicians" who review and approve plans and "a small group of customers." Specific qualifications (e.g., radiologist with X years of experience) are not provided. The document highlights that "qualified clinicians" review plans and may subject them to quality assurance before treatment, implying their role in validating the plans generated by the system.
4. Adjudication Method for Test Set:
Not applicable, as no formal clinical test set or adjudication process for a diagnostic outcome was performed. The document mentions "qualified clinicians" review and approve plans, but this isn't an adjudication method for a test set in the context of an effectiveness study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "Clinical trials were not performed as part of the development of this feature." Therefore, an MRMC comparative effectiveness study was not conducted.
6. Standalone (Algorithm Only) Performance Study:
Yes, in a non-clinical context. The document refers to "Verification tests, including algorithm test cases," and "algorithm accuracy requirements." It states that "Monaco successfully passed both verification and algorithm testing," suggesting a standalone evaluation of the algorithms.
7. Type of Ground Truth Used:
For the non-clinical "verification tests" and "algorithm test cases," the ground truth would likely be established through:
- Pre-defined Pass/Fail Criteria: These would be based on engineering specifications and expected output from the algorithms.
- Comparison to Known Analytical Solutions/Benchmarks: For specific algorithm calculations (e.g., dose distribution), "ground truth" would be established by comparing the software's output to mathematically derived solutions or outputs from trusted reference calculators.
- Outputs from Predicate Devices: The text mentions "the same algorithm accuracy requirements as those used to evaluate the XiO RTP System and the Focal Workstation," implying that the performance of predicate devices might serve as a benchmark or a form of 'ground truth' for comparison during testing.
For the "on-site validation testing using actual patient data," the "ground truth" for clinical fitness would likely involve:
- Clinical Acceptability: Expert opinion from the "small group of customers" (clinicians) on whether the generated plans were clinically appropriate and safe.
- Quality Assurance (QA) Practices: Comparison against established QA standards for radiation oncology treatment plans.
8. Sample Size for the Training Set:
Not specified. The document does not provide details on the training methodology or the datasets used to develop the algorithms within the Monaco RTP System.
9. How Ground Truth for Training Set Was Established:
Not specified. Since details about the training set are not provided, how its ground truth was established is also not mentioned.
§ 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.