(309 days)
The PEREGRINE™ Radiation Therapy Dose Calculation System is intended to be used for radiation therapy in conjunction with a Radiation Treatment Planning system to calculate dose distributions. It is to be used by the physician and/or other competent health aooo alombation clinical review and judgement of radiation treatment plans. The goal of the protections is to produce consistent highly accurate dose calculations using the Monte Carlo algorithms.
The PEREGRINE™ Radiation Therapy Dose Calculation System is used in conjunction with a radiation treatment planning system to provide the dose distribution for radiation therapy treatments employing radiation sources and associated beam modifiers for clinical review and judgement prior to treating the patient. The PEREGRINE™ Radiation Therapy Dose Calculation System is intended to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist, or dosimetrist.
The PEREGRINE Radiation Therapy Dose Calculation System is a 3-D Monte Carlo radiation transport system designed to provide accurate dose calculations for radiation therapy treatment planning. PEREGRINE combines Monte Carlo-based modeling of the accelerator beam production system, Monte Carlo simulation of treatment-specific beam modifiers and Monte Carlo transport in the patient to provide a robust and accurate representation of the radiation source, beam modifiers and heterogeneities in the patient. PEREGRINE has been designed to provide highly accurate, high resolution radiation dose calculations rapidly on economical, commercially available computer microprocessors and to be easily integrated with commercial radiation treatment planning systems. In order to ensure its accuracy, PEREGRINE has been verified against a comprehensive set of clinical measurements designed to stress the physics algorithms for a full range of clinically relevant materials, densities and beam energies for open, blocked, wedged and compensated fields incident on both simple phantoms and phantoms with a variety of surface and sub-surface heterogeneities.
Here's an analysis of the acceptance criteria and study information for the PEREGRINE™ Radiation Therapy Dose Calculation System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain explicit, quantitative acceptance criteria or a direct table comparing them to reported device performance. It generally states that the device "meets the design criteria and user needs" and that "Test completion shows that the device performs and is substantially equivalent to the predicate system."
However, we can infer the intent of the acceptance criteria from the device description and the non-clinical tests. The overarching criterion is accuracy of dose calculations.
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Accuracy of 3-D Monte Carlo radiation transport calculations across a full range of clinically relevant materials, densities, and beam energies. | PEREGRINE verified against a comprehensive set of clinical measurements designed to stress the physics algorithms for a full range of clinically relevant materials, densities and beam energies for open, blocked, wedged and compensated fields incident on both simple phantoms and phantoms with a variety of surface and sub-surface heterogeneities. |
| Robustness and accurate representation of the radiation source, beam modifiers, and heterogeneities in the patient. | PEREGRINE combines Monte Carlo-based modeling of the accelerator beam production system, Monte Carlo simulation of treatment-specific beam modifiers and Monte Carlo transport in the patient to provide a robust and accurate representation of the radiation source, beam modifiers and heterogeneities in the patient. |
| High accuracy, high resolution radiation dose calculations. | PEREGRINE has been designed to provide highly accurate, high resolution radiation dose calculations. |
| Safety and effectiveness of the software. | Validation and verification testing of the PEREGRINE Radiation Therapy Dose Calculation System demonstrate that the software is safe and effective. |
| Substantial equivalence to the predicate device (ADAC Laboratories Pinnacle3 3D Treatment Planning Throughput K926008). | Test completion shows that the device performs and is substantially equivalent to the predicate system for those features for which this submission is being made as well as overall performance. |
| Compliance with design criteria and user needs. | Verification and validation tests were completed in accordance with the test plans. They prove that the PEREGRINE Radiation Therapy Dose Calculation System meets the design criteria and user needs. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states that the device was "verified against a comprehensive set of clinical measurements." It does not specify a numerical sample size for this test set (e.g., number of patients, number of phantom configurations).
- Data Provenance: The measurements are referred to as "clinical measurements," implying they reflect a real-world clinical context, but it doesn't specify the country of origin. The study appears to be prospective in the sense that the measurements were likely taken specifically for the verification of the PEREGRINE system, rather than retrospectively collected from existing patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. The ground truth appears to be based on "clinical measurements" and the physics principles inherent in Monte Carlo simulations.
4. Adjudication Method for the Test Set
The text does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. The verification seems to rely on the direct comparison of the system's calculations against the "comprehensive set of clinical measurements."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or described in the provided text. The evaluation focuses on the standalone performance of the dose calculation system, not on its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone (algorithm only) performance evaluation was done. The description of the verification process—"verified against a comprehensive set of clinical measurements designed to stress the physics algorithms"—directly pertains to the algorithm's performance in generating dose calculations. The system is designed to "provide accurate dose calculations" and its "accuracy" was verified. There is no mention of physician interaction being part of this core verification.
7. The Type of Ground Truth Used
The primary type of ground truth used was clinical measurements. These measurements were used to stress the physics algorithms, implying they represent real-world physical dose distributions, likely obtained from dosimetric equipment in phantoms.
8. The Sample Size for the Training Set
The text does not specify a sample size for the training set. It refers to the system's development using "design controls" and "Quality system design control and product release procedures," indicating a structured development process, but no details on training data are provided. As a dose calculation system based on physical models (Monte Carlo), it may not have a "training set" in the same way a machine learning algorithm would, but rather internal physics parameters and models derived from fundamental principles and potentially calibrated against general physical data.
9. How the Ground Truth for the Training Set Was Established
The text does not explicitly describe how ground truth for any "training set" was established. Given the nature of a Monte Carlo radiation transport system, its core "ground truth" for development would likely be based on fundamental physics laws, established physical constants, and potentially extensive experimental data from various radiation sources and materials, rather than a specific "training set" with established ground truth by human experts in the context of typical AI/ML development. The "modeling of the accelerator beam production system" and "simulation of treatment-specific beam modifiers" would rely on established physics and engineering data.
§ 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.