(186 days)
The Explorer 4D™ Treatment Planning System software is intended for use in preparing treatment plans for patients who have intracranial diseases where neurological radio surgery has been prescribed. The software is used to electronically import CT and MR images to determine the precise location of the target, to define and visualize treatment beam locations, and to visualize dose to the target and other structures.
The Explorer 4D™ Treatment Planning System (TPS) provides individual treatment plans for patients undergoing gamma radiation therapy treatment. The TPS provides for the import of patient images and selecting a series of relevant patient images to create a treatment plan. Precise calculation of the dose delivery parameters is supported by the registration of fiducial markers as a reference point between patient images. These images are then annotated with the region of interest (ROI) to be exposed to radiation. Several tools are provided to adjust the ROI based on the desired treatment area, within these regions "shots" (radiation sources) and associated treatment dose levels are defined as they related to a specified collimator size. When the plan definition is completed the operator can save or export the treatment plan.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Explorer 4D™ Treatment Planning System:
The document describes a 510(k) submission for the Explorer 4D™ Treatment Planning System (version 2.1), primarily focused on demonstrating its substantial equivalence to a predicate device (Explorer 4D™ Treatment Planning System version 2.0). The key difference in the new version is the ability to import MR images in addition to CT images.
The acceptance criteria are implicitly tied to demonstrating that the new feature (MR image import and subsequent treatment planning) performs equivalently to the existing functionality (CT image import) and that the overall system remains safe and effective.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list "acceptance criteria" with numerical targets in a typical format. Instead, it frames the performance data in terms of "equivalence," particularly regarding the accuracy of dose calculations when using MR images compared to CT images.
| Acceptance Criteria Category | Specific Criteria (Implicit from "Performance Data" and "Equivalence Comparison") | Reported Device Performance (Summary from text) |
|---|---|---|
| Functional Equivalence | The ability to prepare treatment plans using MR images as well as CT images. | "Functional testing has demonstrated that version 2.1 is safe and effective..." |
| Accuracy Equivalence | Dose calculation accuracy using MR images should be equivalent to that using CT images. | "...accuracy comparison tests have demonstrated equivalent performance using MR images as obtained using CT images." |
| "Test results have been verified by physicist manual calculations as accurate for CT and MR images." | ||
| Safety and Effectiveness | Overall system safety and effectiveness. | "...functional testing has demonstrated that version 2.1 is safe and effective..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for the test set used in "accuracy comparison tests" or "functional testing." It only states that "all tests were conducted with comparison tests" and "production" (which seems to be a typo/phrase fragment but implies real-world or production-like data).
- Data Provenance: Not explicitly stated. The document refers to "MR images instead of CT images" for the new functionality and "comparison tests" between MR and CT results. It does not mention the country of origin or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The document states that "Test results have been verified by physicist manual calculations as accurate for CT and MR images." This implies that qualified physicists were involved in verifying the accuracy, but their specific experience or number is not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. The verification by "physicist manual calculations" suggests an independent assessment, but the process (e.g., blinded, consensus-based) is not detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done or is not reported in this document. The study described focuses on the technical performance and accuracy of the device itself (dose calculations) rather than how human readers' performance with or without AI assistance changes. The device is a treatment planning system, not an AI diagnostic assistant tool for human interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: Yes, the described "accuracy comparison tests" and verification by "physicist manual calculations as accurate for CT and MR images" essentially represent a standalone performance evaluation of the algorithms within the treatment planning system. The goal was to ensure the system's calculations were correct on their own, whether using CT or MR input images.
7. The Type of Ground Truth Used
- Ground Truth Type: The ground truth appears to be "physicist manual calculations" of dose, which served as the reference standard against which the device's calculated results (using both CT and MR images) were compared for accuracy.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable/Not specified. This document pertains to a 510(k) submission for a treatment planning system, not a machine learning or AI-based device that typically requires a large training set. The system likely uses established physics-based dose calculation algorithms which are validated rather than "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable/Not specified, for the same reasons as #8. The "training" of such a system would involve rigorous engineering and physics validation of its algorithms, rather than training on a dataset with established ground truth.
§ 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.