(142 days)
EPIgray is a software to be used by radiation oncologist and medical physicist to detect errors in the delivery of high energy X-rays during the course of patient treatment. This product verifies if the reconstructed dose, computed by the system, is in agreement with the planned dose given by the treatment planning system. This product uses the measurements performed by an Electronic Portal Imaging Device (EPID). This product uses the prescription computed by the treatment planning system. This product in not used to give a prescription of the radiation therapy.
EPIgray is comprehensive software that allows the user to perform an in-vivo dosimetry by means of imaging device such as an Electronic Portal Imaging Device (EPID). The product is composed of: EPIgray workstation and In-Vivo Manager tool. Epigray workstation is an extension of an already cleared product: ISOgray planning system (K103146). It uses only two modules of the previously approved system: Information module and Exacor module. In Vivo manager software is a year application intended for in-vivo measurements management. In particular, it allows to retrieve, on a web browser, the result of dose reconstruction by EPIgray workstation based on EPID.
The provided text is a 510(k) premarket notification for DOSIsoft's EPIgray software. It outlines the device's description, intended use, and substantial equivalence to a predicate device. However, it explicitly states that clinical trials were not performed, and therefore, an acceptance criteria table and a comprehensive study demonstrating direct device performance against such criteria are not provided in the document.
The document focuses on non-clinical verification and validation testing to ensure the system works according to requirements, rather than a clinical study with detailed performance metrics.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not available in the provided text. The document states: "Clinical trials were not performed as part of the development of this product." and "However, algorithm evaluation was performed by Medical Physicists team using measured data in a clinical facility. Evaluation summary is available in tab 13 of this submission." Without access to "tab 13," specific acceptance criteria and reported device performance metrics cannot be tabulated.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "measured data in a clinical facility" was used for algorithm evaluation, but the size of this dataset is not specified.
- Data Provenance: "measured data in a clinical facility" suggests clinical data, likely retrospective, given no clinical trials were performed. The country of origin is not specified, but since the manufacturer is based in France and the evaluation was done by a "Medical Physicists team," it could be from a French clinical facility or an unspecified international setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not explicitly stated. The evaluation was performed by a "Medical Physicists team," which implies more than one expert, but an exact number is not given.
- Qualifications of Experts: "Medical Physicists team." Their specific experience (e.g., years of experience) is not mentioned.
4. Adjudication method for the test set:
Not applicable/Not mentioned. Since the evaluation involved a "Medical Physicists team" working with "measured data," it's more likely they were assessing algorithmic accuracy against physical measurements/expected dose rather than adjudicating discrepancies in expert interpretations. No specific adjudication method (like 2+1 or 3+1) is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. The document explicitly states: "Clinical trials were not performed." Therefore, no MRMC comparative effectiveness study was conducted to assess human reader improvement with AI assistance. The intended use of EPIgray is described as a software for error detection and dose reconstruction, which implies a standalone function that outputs warnings, not directly a tool for human readers to improve their diagnostic accuracy in a MRMC setting.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, implicitly. The algorithm evaluation by the Medical Physicists team using measured data in a clinical facility suggests a standalone performance assessment. The device's function is described as using EPID images to reconstruct dose and compare it to the planned dose, activating warnings. This is an algorithm-only function without explicit human-in-the-loop performance being evaluated in this submission.
7. The type of ground truth used:
The ground truth appears to be based on physical measurements and planned dose data. The device reconstructs the dose (based on EPID images) and compares it to the "planned dose given by the treatment planning system." The "algorithm evaluation was performed by Medical Physicists team using measured data," suggesting that these measurements (likely independent dosimetry measurements or precise EPID measurements used as a reference) served as a form of ground truth for assessing the accuracy of the reconstructed dose.
8. The sample size for the training set:
Not mentioned. The document focuses on the evaluation (test) phase and does not provide details regarding the training set's sample size.
9. How the ground truth for the training set was established:
Not mentioned. As the document doesn't discuss the training set, there's no information on how its ground truth was established.
§ 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.