(273 days)
MRCAT is used with Ingenia 1.5T and 3.0T MR systems.
Intended Use:
MRCAT imaging is intended to provide the operator with information of tissue properties for radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning.
Indications for use:
MRCAT is indicated for radiotherapy treatment planning for prostate cancer patients.
MRCAT is a software application to Ingenia 1.5T and 3T MR systems. MRCAT is available to the customer as an option to Ingenia MR-RT package, which is a set of accessories for Ingenia systems.
Automated generation of MRCAT images takes place at the MR console of Ingenia. The embedded image post-processing runs in the background parallel to image acquisition. MRCAT algorithms enable automatic tissue characterization of five tissue types; air, fat, water-rich tissue, spongy bone and compact bone. Subsequent bulk-density assignment provides MRCAT images with CT-based density information.
The provided text does not contain detailed acceptance criteria and the comprehensive study that proves the device meets them in the format requested. However, it offers some insights into the validation process and the claims made.
Here's an attempt to extract and infer information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document mentions gamma analysis with criterion of 3%/3mm as a method to show the robustness of the MRCAT algorithm for producing equivalent dose plans to CT using MRCAT images. This implies that the acceptance criterion is that the dose plans generated using MRCAT images should be equivalent to those generated using CT, with a 3%/3mm gamma pass rate.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Robustness of MRCAT algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm (implicitly, a high pass rate would be required) | "The robustness of the MRCAT algorithm for producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm is shown by post-processing MRCAT images from prostate cancer patients, and calculating dose using the MRCAT images." (No specific pass rate percentage is provided in this summary.) |
Additional acceptance criteria related to software development and validation were mentioned in the "Summary of Non-Clinical Tests," but these are general quality assurance measures rather than specific performance metrics for the final output:
- Risk Analysis
- Testing on unit level (Subsystem verification)
- Integration testing (System verification)
- Final acceptance testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification)
The document states, "All the tests performed for MRCAT software were successful. All defects have been analyzed and are confirmed that they are not safety defects and will not cause any hazardous situation on using this application."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "The robustness of the MRCAT algorithm... is shown by post-processing MRCAT images from prostate cancer patients."
- Sample Size: The exact number of prostate cancer patients used in the clinical test is not specified.
- Data Provenance: The document does not specify 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 the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The ground truth for dose plan comparison is implicitly assumed to be CT-based dose plans, but the expert involvement in establishing this ground truth or comparing the MRCAT-derived plans is not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
- MRMC Study: No MRMC comparative effectiveness study involving human readers and AI assistance is described. The device's primary function is to generate images for treatment planning, not to assist human interpretation directly in a diagnostic workflow. The "clinical test" described focuses on the comparison of dose plans generated by the algorithm (MRCAT) against CT, not human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the clinical test described appears to be a standalone performance evaluation of the MRCAT algorithm. The "robustness of the MRCAT algorithm for producing equivalent dose plans to CT" was shown by "post-processing MRCAT images... and calculating dose using the MRCAT images." This implies an algorithm-to-algorithm comparison (MRCAT-generated dose plans vs. CT-generated dose plans).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for comparison in the clinical test was CT-based dose plans. The intent is for MRCAT images to provide "radiation attenuation estimation purposes in photon external beam radiotherapy treatment planning," implying that the standard for attenuation estimation is conventional CT. The gamma analysis compares the dose distributions calculated from MRCAT images to those calculated from CT images.
8. The sample size for the training set
This information is not provided in the document. The description focuses on the clinical evaluation of the algorithm's output rather than its development or training data.
9. How the ground truth for the training set was established
This information is not provided in the document.
§ 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.