(44 days)
The M-Vu™ CAD Station is intended to support the acquisition and storage of medical images for subsequent digital analysis and processing. The medical imagery can be obtained from film format (digitized by a commercial FDA-cleared medical digitizer) or digital format transmitted via a standard DICOM network interface. The CAD Station can print case information and can connect over a Local Area Network and interface with the M-Vu Viewer Station. The CAD Station is intended for use by a technician under the supervision of a medical professional.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
The M-Vu™ CAD Station is a computer-based system that supports the acquisition and storage of medical images for subsequent digital analysis and processing. The system can obtain digitized imagery from two sources: 1) digitized film images from a medical digitizer that is included as part of the system or 2) digitized images obtained from different sources and sent to the CAD Station via a DICOM network interface. The CAD Station is not intended as an archival device.
The CAD Station has several commercial components integrated together on a custom cart. The components include a 510(k)-cleared medical digitizer for scanning films, a printer for report generation, a touch screen monitor for control and displaying system status and error messages, a Windows™-OS computer for executing control software and for temporary storage of imagery and an uninterruptible power supply. The CAD Station communicates via a standard Ethernet network and can support an interface to other PACS devices through a DICOM interface. It also communicates to the M-Vu™ Viewer Station (K060451) to provide case reports including low resolution radiographic images.
The user interface to the CAD Station is via a touch screen monitor. The monitor allows control of the digitizer and provides system status information. While the system is intended to be operated in an unattended batch mode, case priorities can be manually adjusted for higher priority film or digital cases. Also, user specific configuration information and options can be accessed through an onscreen keyboard.
The printer automatically generates case reports with low resolution imagery and a printed (unique) bar code. The bar code is then used to link the case reports to the graphical imagery on the M-Vu Viewer Station.
The provided text describes the M-Vu™ CAD Station, a device intended to support the acquisition and storage of medical images. However, it explicitly states, "Discussion of Clinical Tests Performed: Not applicable." Therefore, the document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria based on clinical performance.
The submission focuses on establishing substantial equivalence to a predicate device (Consultiva™ Case Input Station, K#031132) through non-clinical testing, particularly regarding safety and performance, including "software validation and verification testing."
Since no clinical study was performed or discussed, the following information cannot be extracted from the provided text:
- Table of acceptance criteria and reported device performance: No clinical performance data is presented.
- Sample size used for the test set and data provenance: No clinical test set.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance (algorithm only without human-in-the-loop performance): Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for the training set: No clinical training set mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 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).