(11 days)
Impax Volume Viewing is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is intended as a general purpose digital medical image processing tool, with optionality to facilitate visualization and measurement of vessel features.
Other optional functionality is intended for the registration of anatomical (CT) on functional volumetric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).
Impax Volume Viewing software is a visualization package for PACS workstations. It is intended to support radiographer, medical imaging technician, radiologist and referring physician in the reading, analysis and diagnosis of DICOM compliant volumetric medical datasets. The software is a general purpose digital medical image processing tool, with optional functionality to facilitate visualization and measurement of vessel features.
Other optional functionality is intended for the registration of anatomical (CT) on functional volumerric image data (MR) to facilitate the comparison of various lesions. Volume and distance measurements are intended for evaluation and quantification of tumor measurements, and other analysis and evaluation of both hard and soft tissues. The software also supports interactive segmentation of a region of interest (ROI).
Impax Volume Viewing is a software accessory to Agfa's Impax Picture Archiving and Communications system.
It is a tool for conveniently viewing and manipulating cross-sectional image series' for display in any orientation and slice thickness. A second series can be registered or fused to the first automatically, manually or with user defined landmarks. Segmentation of blood vessels and airfilled structures facilitate the visualization of vessel features. Color maps, subtraction views, multiple screen layouts and tools for measurement, calculations and annotations are provided.
Here's a breakdown of the acceptance criteria and the study information for the Impax Volume Viewing device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided 510(k) summary does not explicitly define quantitative acceptance criteria for the Impax Volume Viewing software. Instead, it relies on demonstrating substantial equivalence to predicate devices through functional and technological comparisons, along with verification and validation testing. The reported "performance" is that the device "meets performance, measurement and usability requirements" and conforms to certain standards.
Therefore, the table will reflect the general performance claims rather than specific numerical acceptance criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Device functions similarly to predicates. | "Similar to the predicate devices." "Principles of operation and technological characteristics... are the same." "Has an Indications For Use Statement largely similar to the statements for the two predicates." |
| Intended Use Equivalence | Device has the same intended use as predicates. | "Intended uses... are the same." |
| Technological Characteristics | Software processes 3D image data, offers viewing/manipulation, registration, segmentation, measurement, etc. | "Tool for conveniently viewing and manipulating cross-sectional image series," "second series can be registered or fused," "Segmentation of blood vessels and air-filled structures," "Color maps, subtraction views, multiple screen layouts and tools for measurement, calculations and annotations are provided." |
| Performance | Meets general performance, measurement, and usability requirements. | "Verification and validation testing confirm the device meets performance, measurement and usability requirements." |
| Standards Conformance | Conforms to specified medical device and quality management standards. | Conforms to EN12435:2006, ISO 14971:2007, and ISO 13485:2003. |
| Safety and Effectiveness | Differences from predicates do not alter therapeutic/diagnostic effects. | "Differences in the new device and the predicates do not alter their intended therapeutic/diagnostic effects." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified. The document states "Verification and validation testing" was performed but does not detail the size of the dataset used for these tests.
- Data Provenance: Not specified. It's not mentioned if the data was retrospective or prospective, or its country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified. Given that no clinical trials were performed, it's unlikely that external experts were used for establishing a "ground truth" in a clinical context for the test set as typically understood in a performance study. The testing seems more focused on engineering verification and validation.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified. Without explicit information on expert review or clinical studies, there's no mention of an adjudication method like 2+1 or 3+1.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study Done: No. The document explicitly states: "No clinical trials were performed in the development of the device." An MRMC study would fall under clinical trials.
- Effect Size of Human Readers Improvement with AI vs. without AI assistance: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Standalone Study Done: Yes, implicitly. The "Verification and validation testing" would primarily assess the software's ability to correctly perform its functions (e.g., rendering, registration accuracy, measurement accuracy, segmentation capabilities) without necessarily involving human interpretation as a primary performance metric beyond usability. However, the document doesn't provide specific standalone performance metrics.
7. Type of Ground Truth Used:
- Type of Ground Truth: For the "verification and validation testing," the ground truth would likely be established through:
- Engineering specifications and requirements: The software's output would be compared against predefined correct behaviors, mathematical principles, and known accurate measurements.
- Known good datasets: Using datasets with established characteristics to confirm the software's processing and display accuracy.
- Comparative analysis with predicate devices: Ensuring the new device's output is consistent with the established performance of the predicate devices.
- Given the nature of the device (visualization and manipulation tool), "pathology" or "outcomes data" are less likely to be the primary ground truth for its technical performance rather than its diagnostic utility.
8. Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This device is described as a "visualization package" and a "general purpose digital medical image processing tool." It is not leveraging machine learning or AI models in the sense that requires a "training set" for model development. The software's functionality (rendering, registration, segmentation, measurement) is based on deterministic algorithms and user interaction rather than learned patterns from a training dataset.
9. How the Ground Truth for the Training Set Was Established:
- How Ground Truth for Training Set Was Established: Not applicable, as there is no mention of a training set for machine learning.
§ 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).