(48 days)
MammoWorkstation is designed to assist radiologists in conducting primary diagnostic review for diagnostic and screening mammography through flexible and interactive manipulation of multi-modality softcopy images.
It provides image review, manipulation, analysis, post-processing and printing capabilities that support image management display needs in the medical environment.
MammoWorkstation is designed to give easy and economic access to and display of multi-modality softcopy images, structured reports, and CAD results through interfaces to various image storage devices using DICOM or similar interface standards. It supports creation of structured reports according to the DICOM breast imaging report templates.
MammoWorkstation supports teleradiology and teleconferencing providing access to multi-modality softcopy images and structured reports in multiple locations within and outside the hospital.
Lossy compressed mammographic images must not be used for primary diagnostic interpretation unless approved for use in digital mammography.
Display monitors used for primary diagnostic interpretation of mammographic images must be approved for use in digital mammography.
The MammoWorkstation is a medical image review workstation software for diagnostic and screening mammography. It is a software product. The product consists of features that allow the qualified medical professional to review patient medical images and to apply tools to cover the relevant aspects of an efficient review workflow. In addition, the system supports creation of report documents.
The provided text describes the "MammoWorkstation" device and its 510(k) summary. However, it does not contain any information about acceptance criteria, device performance metrics, or a study proving its conformance to such criteria.
The document is a regulatory submission for a medical device (MammoWorkstation) seeking clearance from the FDA. It focuses on demonstrating "substantial equivalence" to previously cleared predicate devices, rather than presenting a performance study with specific acceptance criteria and results.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide the requested tables and details. All the requested points (1-9) would require a detailed performance study, which is absent in this 510(k) summary.
The document primarily states:
- The product is a medical imaging software for diagnostic and screening mammography.
- It provides image review, manipulation, analysis, post-processing, and printing capabilities.
- It supports teleradiology and teleconferencing.
- It is developed according to ISO 13485:2003, IEC 62304, and ISO 14971, and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0.
- Its intended use and technological characteristics are substantially equivalent to predicate devices (Cedara I-ReadMammo, Sectra Workstation IDS5/mx.net, GE Healthcare Centricity Radiology RA600).
- Differences lie in higher specialization for mammograms, structured report capabilities aligned with DICOM breast imaging templates, and user interface/automation features (e.g., automatic hanging protocol).
This type of regulatory submission often relies on a review of software development processes, verification and validation activities (which might include internal testing), and comparison to existing devices, but it typically does not present a detailed clinical or technical performance study with quantifiable acceptance criteria and results as you've requested for AI/CAD devices.
§ 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).