(29 days)
Radiance V4 is a software system intented for treatment planning and analysis of radiation therapy administered with devices suitable for intraoperative radiotherapy.
The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user.
The system functionality can be configured based on user needs.
The intended users of Radiance V4 shall be clinically qualified radiation therapy staff trained in using the system.
Radiance V4 is a planning tool for intraoperative radiotherapy (IORT), an application that provides a simulation of the dose distribution according to the parameters involved in the procedure. These parameters in IORT include the geometry of the applicator, its orientation and position with respect to the patient and IORT device parameters.
Radiance V4 is designed to analyze and plan radiation treatments in three dimensions for the purpose of treating patients with cancer. The user can adjust parameters to achieve a predicted outcome, rather than make a decision intra-operatively. The created treatment plans provide estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by qualified medical personnel.
This document describes the Radiance V4, a software system for radiation therapy treatment planning. The device received 510(k) clearance (K171885) on July 25, 2017, from the FDA.
Here's a breakdown of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state acceptance criteria in a quantitative format with corresponding reported device performance metrics. Instead, it describes a process of design verification testing to assure the changes were "appropriate, safe and effective for the intended use." The performance data is summarized as addressing the "modifications and the impact on performance and safety."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of patient data or clinical images. The testing described is "design verification testing" related to technical modifications of the software. Therefore, sample size and data provenance in terms of patient data are not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The study focuses on design verification and technical performance rather than clinical performance based on expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This information is not provided. As the testing is design verification, a clinical adjudication method would not be relevant.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission is for a treatment planning software system, and the focus is on the software's ability to accurately calculate dose distributions and incorporate new features, not on improving human reader performance in diagnosis.
6. Standalone Performance
The primary function of Radiance V4 is a standalone planning tool. The "design verification testing" would inherently assess the algorithm's performance in calculating dose distributions and implementing the new features. However, specific standalone performance metrics (e.g., accuracy of dose calculation compared to a gold standard) are not quantitatively reported in this summary.
7. Type of Ground Truth Used
The "ground truth" for the design verification testing would likely involve:
- Technical specifications and requirements: Ensuring the software behaves according to its designed functionality.
- Physics-based models and simulations: Verifying the accuracy of dose calculations based on established radiation physics.
- Comparisons to established physical measurements (e.g., phantom measurements for dose distribution, though not explicitly stated as being performed here).
The document mentions that the changes include "improved accuracy of the dose in the first millimeters to the applicator surface" and "calculation of water equivalent dose." These imply a comparison against a known, accurate dose distribution or calculation method.
8. Sample Size for the Training Set
No information about a "training set" is provided. As a treatment planning software, it's not a machine learning model that requires a labeled dataset for training in the conventional sense. The development would involve engineering and physics principles rather than AI training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no mention of a training set for a machine learning model.
§ 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.