(16 days)
The Sectra Workstation is intended for the manipulation and displaying of medical images, including mammograms. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
Device options make possible mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc.; and teleconferencing.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
The Sectra Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The Sectra Workstation is used as a client together with a Sectra provided server (Sectra PACS Core, Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.
The Sectra Workstation is a family of devices, including several workstations or types of workstations (see Table 1).
The provided text is a 510(k) summary for the Sectra Workstation and the FDA's clearance letter. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, a study proving device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.
The document states that the device is "developed according to ISQ 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0" and concludes that it is "safe, effective, and substantially equivalent to the predicate device." This indicates that the regulatory pathway relied on demonstrating adherence to existing standards and equivalence to an already approved device, rather than a new performance study with specific acceptance criteria.
Therefore, I cannot populate the requested table and answer the study-related questions based on the provided input.
The information requested, such as acceptance criteria, sample sizes for test and training sets, details of ground truth establishment, and MRMC studies, is typically found in clinical validation studies or performance bench-marking reports, which are not part of this 510(k) summary.
§ 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).