(90 days)
Advantage Windows Fusion provides an easy means for comparison of three dimensional (3D ) images from computed tomography ( CT ) and magnetic resonance ( MR). It allows 3D registration between two volumetric acquisitions, which may come from different acquisition modalities ( CT / MR), for use in diagnostic radiology or radiation therapy planning.
Advantage Windows Fusion is a software option for the Advantage Windows Workstation that provides easy comparison of three dimensional (3D) images from computed tomography (CT) and magnetic resonance (MR). It allows 3D registration between two volumeric acquisitions, which may come from different acquisition modalities ( CT / MR).
Application examples include:
- a use of previously recorded diagnostic information from follow-up studies.
- o combination of CT and MR for better volume definition.
- · definition of a volume of interest within one patient model,
- with automatic report in the other model ..
- " fusion of functional and anatomical images.
- a medical education.
- 6 better communication of clinical results to referring physicians.
The provided document for K983256, "ADVANTAGE WINDOWS FUSION SUMMARY OF SAFETY AND EFFECTIVENESS," does not contain information related to specific acceptance criteria or a detailed study proving the device meets such criteria.
The document is a 510(k) summary, which focuses on establishing substantial equivalence to a predicate device. It describes the device, its intended use, and compares it to a previously cleared device (K941223, "Fusion and Registration feature of Advance Analysis Software").
Here's what can be extracted from the document regarding studies and validation:
- Acceptance Criteria and Reported Device Performance: This information is not provided in a quantifiable or tabular format. The document states, "The AW Fusion option will be fully verified/validated per the program test plans," but does not present the results of these tests or any specific performance metrics against acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method: Not mentioned.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned. The document primarily focuses on the device's functionality and its equivalence to a predicate, not on its comparative effectiveness with human readers.
- Standalone (algorithm only without human-in-the-loop performance) study: Not explicitly mentioned as a separate study. The document describes the software option's capabilities, implying standalone operation for image fusion. However, no performance metrics are provided.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion from the document:
The document emphasizes that:
- The Advantage Windows Fusion provides 3D information that allows comparison of volumetric acquisitions from different studies and modalities.
- The potential hazards are controlled by a risk management plan (Hazard Analysis/Risk Management Summary, Software Development and Validation Process, Software Verification Plan).
- The product provides images comparable to the predicate device.
The 510(k) process primarily relies on demonstrating substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device. In this case, the justification for safety and effectiveness is largely based on the similarity to the predicate device and the implementation of standard software development and validation processes, rather than a detailed performance study with quantifiable acceptance criteria.
§ 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).