(106 days)
The application can be used in clinical workflows that benefit from the co-registration of vascular image data as a planning or preplanning step.
Image Fusion Angio is intended to co-register digital subtraction angiographies with volumetric medical image data.
The provided text describes the acceptance criteria and a study proving the device meets these criteria for the Brainlab Elements Image Fusion Angio device.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative thresholds in a table format within this document. Instead, the document focuses on demonstrating substantial equivalence to predicate and reference devices, particularly in terms of fusion accuracy.
The performance is reported through nonclinical performance testing (accuracy tests).
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance (Image Fusion Angio) | Reported Reference Device Performance (iPlan RT Image) |
|---|---|---|---|
| Phantom Bench Test (CTA, 3D-DSA to 2D-DSA) | Similar or better targeting accuracy compared to the reference device and within expected clinical limits for 2D/3D fusion. | 0.5 mm +/- 0.2 mm | 0.8 mm +/- 0.3 mm |
| MRA Bench Test (MRA to 2D-DSA) | Similar or better targeting accuracy compared to the reference device and within expected clinical limits for 2D/3D fusion. | 0.3 mm +/- 0.1 mm | 3.2 mm +/- 0.3 mm |
| Retrospective Study (Clinical Data) | Similar targeting accuracy to phantom bench test and existing literature, and fusions reviewed by medical experts. | 0.36 mm +/- 0.17 mm | Not applicable (device only performance) |
2. Sample Size Used for the Test Set and Data Provenance
- Phantom Bench Test & MRA Bench Test: "The test was repeated 3 times" for each. The data provenance is controlled lab/bench test scenario.
- Retrospective Study: "We used 35 datasets from 16 different clinical sites (11 different scanner types)." The data provenance is retrospective clinical data from multiple sites. The country of origin is not explicitly stated but implies a multi-center approach.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Retrospective Study: "The gold standard fusions were defined by medical experts." The number of experts is not specified (e.g., "by medical experts" could mean one, two, or more).
- Qualifications of Experts: The document states "medical experts" but does not provide specific qualifications (e.g., "radiologist with 10 years of experience" or "neurosurgeon").
4. Adjudication Method for the Test Set
- Retrospective Study: "The gold standard fusions were defined by medical experts." and "All fusions were further reviewed by medical experts." This suggests expert consensus or review, but the specific adjudication method (e.g., 2+1, 3+1) is not detailed.
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 involving human readers improving with AI vs. without AI assistance was not done or reported in this document. The study focuses purely on the accuracy of the algorithm's 2D/3D co-registration.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the accuracy tests (Phantom Bench Test, MRA Bench Test, Retrospective Study) evaluate the Brainlab Elements Image Fusion Angio and iPlan RT Image algorithms in a standalone manner, measuring their targeting accuracy against a defined gold standard. While medical experts defined and reviewed the ground truth/gold standard, the performance being measured is that of the algorithm itself, not an interaction with a human.
7. The Type of Ground Truth Used
- Phantom Bench Test & MRA Bench Test: "gold standard fusion" (likely established by precise manual registration or by the design of the phantom itself). This represents a highly controlled, measurable ground truth.
- Retrospective Study: "The gold standard fusions were defined by medical experts." This indicates expert consensus as the ground truth for clinical data.
8. The Sample Size for the Training Set
- The document does not provide information regarding the sample size used for the training set for the Image Fusion Angio algorithm. This section only covers performance testing (validation).
9. How the Ground Truth for the Training Set Was Established
- Since the training set information is not provided, how its ground truth was established is also not detailed in this document.
§ 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).