(197 days)
MRCAT Pelvis is a software add-on for 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 estimation purposes in photon external beam radiotherapy treatment planning.
Indications for use:
MRCAT Pelvis is indicated for radiotherapy treatment planning of soft tissue cancers in the pelvic region.
MRCAT Pelvis is a software application to Ingenia 1.5T and 3T MR systems. MRCAT Pelvis 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, waterrich tissue, spongy bone and compact bone. Subsequent density assignment provides MRCAT images with CT-like density information.
The provided text is a 510(k) summary for the Philips MRCAT Pelvis device. While it describes the device's intended use and general testing, it does not contain a detailed study demonstrating how the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or expert qualifications.
Therefore, many of the requested details cannot be extracted directly from this document.
Here's a breakdown of what can be inferred or is explicitly stated, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, accuracy, etc. It only states that the robustness of the algorithm was shown by "producing equivalent dose plans to CT using gamma analysis with criterion of 3%/3mm." This implies an acceptance criterion related to dosimetric accuracy, but no precise performance numbers (e.g., % of plans meeting 3%/3mm gamma) are given.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Production of equivalent dose plans to CT using gamma analysis. | "Robustness... shown by post-processing MRCAT images from patients, and calculating dose using the MRCAT images." (Criterion: 3%/3mm gamma analysis) |
| Spatial accuracy of radiation attenuation estimates. | "MRCAT Pelvis images are spatially accurate radiation attenuation estimates." |
| Software compliance with voluntary standards (list provided). | "All requirements are met for the MRCAT Pelvis application." |
| Successful completion of all tests performed for the software. | "All the tests performed for MRCAT Pelvis software were successful." |
| No safety defects or hazardous situations from analyzed defects. | "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
- Sample size: Not specified. The document only mentions "post-processing MRCAT images from patients." It does not provide the number of patients or cases.
- Data provenance: Not specified (e.g., country of origin). It also doesn't explicitly state whether the data was retrospective or prospective, though "post-processing MRCAT images from patients" suggests retrospective analysis of data acquired for other purposes or as part of a study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not specified. The primary ground truth reference appears to be CT scans for dosimetric comparison, rather than human expert interpretation of the MRCAT images themselves for diagnostic purposes.
4. Adjudication method for the test set
Not applicable/specified. The primary comparison is between MRCAT-derived dose plans and CT-derived dose plans using gamma analysis, not subjective interpretation requiring adjudication among experts.
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 MRMC comparative effectiveness study is described. The device is a "software add-on" that generates CT-like density information from MR images for radiation treatment planning. It's not designed for human readers to interpret MR images directly for diagnosis with AI assistance, but rather to provide input for a treatment planning system. Therefore, an MRMC study in the traditional sense of human reader performance with/without AI assistance is not relevant to this device's function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone evaluation was performed. The robustness of the "MRCAT Pelvis algorithm" was evaluated by comparing its output (dose plans from MRCAT images) against a reference (dose plans from CT) using gamma analysis. This is an algorithm-only performance evaluation.
7. The type of ground truth used
The ground truth for evaluating dosimetric accuracy appears to be CT imaging and subsequent dose plan calculations based on CT data. The MRCAT device aims to provide "CT-like density information" and "equivalent dose plans to CT."
8. The sample size for the training set
Not specified. Information about the training set size or methodology for the MRCAT algorithm is not provided in this document.
9. How the ground truth for the training set was established
Not specified. How the ground truth for any training data (if machine learning was used extensively to develop the underlying algorithm) was established is not mentioned in this 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.