(55 days)
MuCheck is an independent computer based verification of the monitor unit or dose calculated by the primary radiation treatment planning system.
The intended use of the MuCheck software has been extended to include an optional module, MuCheck/TomoCheck to independently verify the dose for single point that has been previously calculated by the Tomotherapy Hi Art treatment planning system or other points as determined by the physicist.
The MU Check Program is a software program that is designed to operate on an-IBM compatible personal computer in a Windows environment. It has been designed to operate either in a stand alone mode independent of the treatment planning system or to import plans from the treamment planning system. It does not connect to or control any radiation hardware device. MUCheck performs dose calculations to verify the dose calculated by the primary radiation teament planning system. The functionality of the MUCheck program is being extended to include calculations for the Tomotherapy Hi Art system, by this submission.
The provided text describes the MuCheck V9 device, which is a software program designed for dose validation in radiation therapy. The submission specifically details the extension of its functionality to include calculations for the Tomotherapy Hi Art system, through an optional module called TomoCheck.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states: "All system specifications were met and testing performed to demonstrate substantial equivalence." It also mentions, "The non-clinical tests were conducted using the treatment planning system and MU Check TomoCheck module. The test results all matched very closely which supports the claim of substantial equivalence. See Figure 6.0 in section 6 for comparison summary."
Although the specific numerical acceptance criteria (e.g., maximum percentage difference in dose calculation) and the detailed reported performance are not directly provided in the text, the general statement indicates that the MuCheck TomoCheck module performed within acceptable limits when compared to the primary Tomotherapy Hi Art system's calculations. The "very closely matched" outcome implies a high degree of concordance.
2. Sample Size for Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of test cases or "plans" used for the non-clinical tests. It broadly refers to "the non-clinical tests were conducted using the treatment planning system and MU Check TomoCheck module."
- Data Provenance: The document does not provide details on the origin of the data used for testing (e.g., specific treatment plans, patient data, retrospective or prospective). It only states that the tests were conducted with the "treatment planning system."
3. Number of Experts Used to Establish Ground Truth and Their Qualifications:
- Number of Experts: Not applicable or not specified.
- Qualifications of Experts: Not applicable or not specified.
This device is a software for dose calculation verification, not an interpretation device requiring expert human evaluation to establish ground truth for image or clinical findings. The ground truth for its evaluation would be the calculations from the established primary treatment planning system (Tomotherapy Hi Art).
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable.
Similar to the previous point, this device's performance is gauged against a programmatic or calculated ground truth from another system, not against a ground truth established by human adjudicators.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No.
- Effect Size of Human Readers Improvement: Not applicable.
The MuCheck V9 is a standalone dose validation software. Its function is to provide a secondary, independent check of dose calculations, not to assist human readers in interpreting data or making diagnoses. Therefore, an MRMC study comparing human performance with and without AI assistance is not relevant to this device.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
- Standalone Performance: Yes. The entire "Non-clinical tests" section describes the evaluation of the MuCheck TomoCheck module's performance in calculating doses compared to the primary treatment planning system. This is an assessment of the algorithm's standalone capability. The software operates independently to perform these calculations.
7. Type of Ground Truth Used:
- Type of Ground Truth: The ground truth for evaluating MuCheck V9 (TomoCheck module) was the dose calculations performed by the primary radiation treatment planning system (specifically the Tomotherapy Hi Art system). The document states, "The non-clinical tests were conducted using the treatment planning system and MU Check TomoCheck module. The test results all matched very closely which supports the claim of substantial equivalence." This implies that the calculations from the Tomotherapy Hi Art system served as the reference standard.
8. Sample Size for the Training Set:
- Sample Size: Not specified.
The document focuses on the verification and validation of the software. While software like this would have undergone extensive internal development and testing, information about a specific "training set" in the context of machine learning, or a distinct training phase, is not provided. Given the nature of a dose calculation verification tool, its development likely involved rigorous algorithmic design and parameter tuning based on radiation physics principles rather than a traditional machine learning training set as might be found with image recognition AI.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth Was Established: Not specified.
As mentioned above, the concept of a "training set" with established ground truth in the typical machine learning sense is not explicitly discussed for this type of software. Its development would rely on accurate implementation of physics-based dose calculation algorithms.
§ 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.