(90 days)
Visia™ is a medical image processing software application intended for the visualization of images from various sources (e.g., Computed Tomography (CT), Magnetic Resonance (MR), etc). The system provides viewing, quantification, manipulation, communication, and printing of medical images. Visia™ is not meant for primary diagnostic interpretation of mammography.
Visia™ is a medical imaging software platform that allows processing, review, and analysis of multidimensional digital images acquired from a variety of medical imaging modalities. Visia™ offers flexible workflow options to aid clinicians in the evaluation of patient anatomy and pathology. The Visia™ system integrates within typical clinical workflow patterns through receiving and transferring medical images over a computer network. The software can be loaded on a standard off-the-shelf personal computer (PC) and can operate as a stand-alone workstation or in a distributed server client configuration across a computer network. Images can be displayed based on physician preferences using configurable viewing options or hanging protocols. Visia™ provides the clinician with a broad set of viewing and analysis tools to annotate, measure, and output selected image views or reports.
The provided 510(k) summary for MeVis Medical Solutions AG's Visia™ device primarily focuses on demonstrating substantial equivalence to a predicate device (Vitrea® K071331) and discusses general nonclinical testing.
Based on the provided text, there is no detailed information about specific acceptance criteria, a dedicated study proving performance against these criteria, or the methodology typically found in studies for AI/CADe devices. The device, Visia™, is described as a medical image processing software platform for visualization, quantification, manipulation, and printing, rather than an AI/CADe device that performs diagnostic interpretations or provides automated analysis results for which detailed performance metrics would be assessed. The submission explicitly states: "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians." and "Visia™ is not meant for primary diagnostic interpretation of mammography."
Therefore, I cannot populate most of the requested fields as the information is not present in the provided document.
Here's an assessment based on the available information:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated or quantitative for performance) | Reported Device Performance (General statements from submission) |
|---|---|
| Functional Equivalence to Predicate Device | The submission states: "Nonclinical and performance testing results are provided in the 510(k) and demonstrate that the predetermined acceptance criteria are met." It also claims "The design, function, and specifications of Visia™ are similar to the identified legally marketed predicate device." And "The new device and predicate devices are substantially equivalent in the areas of technical characteristics, general function, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices." The validation test plan "was designed to evaluate all input functions, output functions, and actions performed by the software in each operational mode" and "passed all in-house testing criteria including validating design, function, and specifications." |
| Safety and Effectiveness | "The Visia™ labeling contains instructions for use and necessary cautions, warnings and notes to provide for safe and effective use of the device." "Risk Management is ensured via MeVis Medical Solution AG's Risk Management procedure, which is used to identify potential hazards." "These potential hazards are controlled via software development and verification testing." And "Nonclinical tests demonstrate that the device is safe, effective, and is substantially equivalent to the predicate device." |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified. The document refers generally to "nonclinical and performance testing" and a "Validation Test Plan" but does not provide details on the number of cases or datasets used.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The device is a viewing/processing platform, not a diagnostic aid that establishes "ground truth." The submission states "Diagnosis is not performed by the software but by Radiologists, Clinicians and referring Physicians."
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/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 study was not described or implied. The device is explicitly stated as "not meant for primary diagnostic interpretation of mammography" and does not perform diagnosis; therefore, a study on human reader improvement with AI assistance would not be relevant to its intended use as described.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. The device is a "medical imaging software platform" that provides "viewing, quantification, manipulation, and printing." It is a tool for clinicians, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. As a viewing and processing software, the concept of "ground truth" for its performance isn't in the same vein as for a diagnostic AI. The "ground truth" for showing it works would likely relate to the accuracy of its display, measurements, and functional operations compared to predefined specifications or those of the predicate device, which isn't detailed in terms of a specific "ground truth" type here.
8. The sample size for the training set:
- Not applicable. This device is described as general medical image processing software, not an AI/ML algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Device and Evidence provided:
The Visia™ device is a medical image processing software platform. Its 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device (Vitrea® K071331) and on internal "nonclinical and performance testing" to validate its design, function, and specifications. The criteria for acceptance appear to be primarily functional verification against design requirements and comparison to the predicate device's capabilities, rather than quantitative performance metrics for a diagnostic aid that would analyze medical images or perform AI tasks. The submission emphasizes that the software does not perform diagnosis and is not intended for primary diagnostic interpretation.
§ 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).