(15 days)
Advantage Windows /MR Fusion provides an easy means for comparison of three dimensional (3D) images from X-ray angiography (XR: providing anatomical imaging) and Magnetic Resonance (MR: providing anatomical imaging). It allows registration between two volumetric acquisitions, which may come from different acquisition modalities (X-Ray and MR), to help physicians in diagnostic radiology or therapy planning.
The GEMS Advantage Windows X-Ray/MR Fusion software package is an option on Advantage Windows that provides easy comparison of three dimensional (3D) images from X-ray angiography and Magnetic Resonance (MR). It allows 3D registration between two volumer. : acquisitions, which may come from different acquisition modalities, producing fusion of angiographic and other anatomical images.
The provided text is a 510(k) summary for the GE Medical Systems Advantage Windows X-Ray/MR Fusion software package. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device's performance against detailed acceptance criteria via a specific study.
Therefore, many of the requested details about acceptance criteria, study specifics, ground truth, and sample sizes for training/test sets are not explicitly present in this type of regulatory submission document.
However, based on the available information, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide a specific table of acceptance criteria with numerical performance metrics. Instead, the acceptance criterion for regulatory clearance in this context is "substantial equivalence" to legally marketed predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Advantage Windows X-Ray/MR Fusion does not result in any new potential safety risks and performs as well as devices currently on the market. GE considers features of the Advantage Windows X-Ray/MR Fusion to be equivalent to Advantage Windows Fusion (K983256) and Advantage Windows (CT/PET) Fusion (K010336)." |
| Performance to Specifications, Federal Regulations, and User Requirements | Controlled by: "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements." and "Adherence to industry and international standards." |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not specified. This document emphasizes equivalence rather than a new de novo performance study with a specific test set.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. (Ground truth establishment for new performance is not the focus of this 510(k) summary.)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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, an MRMC comparative effectiveness study is not mentioned. This device is for image registration and comparison, not primarily an AI algorithm for diagnostic interpretation in the way that would typically warrant an MRMC study for AI assistance. The focus is on the functional equivalence of the registration capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the software's functional capabilities (3D registration and comparison) were verified as performing "as well as devices currently on the market." This suggests verification of the algorithm's standalone functionality. However, a specific "standalone study" in the context of clinical performance metrics (e.g., sensitivity, specificity) is not described. The validation mentioned ("Software Development, Validation and Verification Process") would cover the standalone performance to specifications.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified directly regarding a clinical ground truth for a performance study. For software validation, "performance to specifications" and "user requirements" would be the 'ground truth' for the validation process.
8. The sample size for the training set
- Not applicable/Not specified. This is a software package for image fusion, not a machine learning model that typically undergoes a training phase with a distinct training set.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as this isn't a machine learning model with a training set.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or justification for meeting acceptance criteria described in this 510(k) summary is based on the concept of substantial equivalence to previously cleared predicate devices.
- Description: GE Medical Systems asserts that its Advantage Windows X-Ray/MR Fusion software package functions are substantially equivalent to:
- Methodology (implied): The equivalence is primarily argued by comparing the functional features and intended use of the new device with the predicate devices. The new device offers "3D registration of anatomical images from X-Ray with anatomical images from MR," which is functionally similar to what the predicate devices do for CT/MR and CT/PET fusion. The document also states that a "Software Development, Validation and Verification Process" was used to ensure performance to specifications, Federal Regulations, and user requirements, along with adherence to industry and international standards. This process would involve internal testing and validation activities but is not detailed as a clinical "study" in this submission.
- Conclusion: The claim is that the device "does not result in any new potential safety risks and performs as well as devices currently on the market," thereby establishing its equivalence. The FDA concurred with this assessment, granting clearance.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).