(87 days)
EVTOOL software module provides the ability to compare and evaluate the radiation dose delivery to the tumor volume and surrounding organs from generated dose volume histograms and radiobiological values. It expands the DMLC IV-ERGO system, which is a combination of a radiation collimator with multiple tungsten leaves that move during delivery of radiation therapy and a computer based treatment planning and control system.
EVTOOL is a software module that has been designed to expand the features and functions of the DMLC IV- ERGO treatment planning software. The software runs on a silicon graphics workstation and Irix operating system. EVTOOL software is used for comparing and evaluating radiation therapy treatment plans from a quantitative and radiobiological point of view. The software displays one or more stored plans for comparison and analysis. It can display the dose volume histograms of the various plans and organ dose statistics (mean, modal, maximum and minimum dose). It allows the user to input radiobiological corrections in order to enhance the evaluation of the treatment plan. It also optimizes the dose prescription by displaying reference dose and number of treatment fractions. EVTOOL is fully integrated into the ERGO treatment planning environment in order to easily exchange information from the patients' database. The patient information is selected and automatically loaded into the EVTOOL software. From the patient database the user can select one or multiple treatment plans to display and calculate the dose statistics, including dose volume histograms and radiobiological models. The analytical information is displayed in 4 windows with a zoom capability. These windows can display the overall plan and individual organs of interest. EVTOOL provides options for incorporating radiobiological corrections to assist the physician in determining the optimal dose prescription and fractionation based on TCP (Tumor Control Probability), NTCP (Normal Tissue Complication Probability) and UTCP (Uncomplicated Tumor Control Probability) values. This software is a useful tool in evaluating the entire volumetric treatment plan, it is not used to directly treat the patient. It provides the physician with a tool to compare various plan versions side by side in order to determine the most appropriate treatment plan to be used with the DMLC IV equipment. The display of the treatment plans within EVTOOL provides a permanent record and effective control on the actual dose delivered to the patient.
The provided text is a 510(k) Premarket Notification for the EVTOOL software. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study with performance metrics. Therefore, many of the requested details about acceptance criteria and study design are not present in this document.
Here's an attempt to answer the questions based only on the provided text, noting where information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not define specific quantitative "acceptance criteria" or report "device performance" in terms of clinical outcomes or diagnostic accuracy. The core of this 510(k) is to demonstrate substantial equivalence to a predicate device for its intended use as a radiation therapy planning assessment tool.
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as such, but inferred from the document's purpose) | Reported Device Performance (No explicit performance metrics in this document) |
|---|---|---|
| Intended Use | The device should function as a tool to compare and evaluate radiation therapy treatment plans from a quantitative and radiobiological perspective, displaying dose volume histograms and organ dose statistics, and allowing for radiobiological corrections. | The EVTOOL software is used for comparing and evaluating radiation therapy treatment plans... It can display the dose volume histograms of the various plans and organ dose statistics... It allows the user to input radiobiological corrections... |
| Safety and Effectiveness | The device should be substantially equivalent in safety and effectiveness to the predicate device (3D Line DMLC IV-ERGO, K001163), enhancing functionality without introducing new safety/effectiveness concerns. | The EVTOOL software is substantially equivalent to the predicate devices. It enhances the functionality of the defined predicate device to provide evaluation tools for radiation therapy treatment planning. |
| Integration | The device should be fully integrated into the ERGO treatment planning environment for easy information exchange. | EVTOOL is fully integrated into the ERGO treatment planning environment in order to easily exchange information from the patients' database. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This document does not describe a clinical performance study with a test set of patient data to evaluate device performance against ground truth. It describes a software module.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The document does not detail a study involving expert-established ground truth.
4. Adjudication method for the test set
- This information is not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC comparative effectiveness study is mentioned or implied in this document. The EVTOOL is described as a tool to assist physicians in evaluating treatment plans, not necessarily as an AI system designed to improve human reader performance in a diagnostic sense in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone performance study is mentioned. The device is a "software module" that "provides the physician with a tool to compare various plan versions." It's explicitly stated, "it is not used to directly treat the patient."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The document does not describe a study requiring ground truth for performance evaluation. The "ground truth" for this type of software would typically be the accuracy of its calculations and displays based on established physics and radiobiology models, which would be validated through software testing processes, not clinical studies with patient outcomes.
8. The sample size for the training set
- Not applicable. This document describes a software module for radiation therapy planning evaluation, not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.