(73 days)
AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
AW Server is a medical software system that allows multiple users to remotely access AW applications from compatible computers on a network. The system allows networking, selection, processing and filming of multimodality DICOM images.
Both the client and server software are only for use with off the shelf hardware technology that meets defined minimum specifications.
The device is not intended for diagnosis of mammography images. The device is not intended for diagnosis of lossy compressed images. For other images, trained physicians may use the images as a basis for diagnosis upon ensuring that monitor quality, ambient light conditions and image compression ratios are consistent with clinical application.
A W Server is a software package delivered with off-the-shelf server-class hardware that allows easy selection, review, processing and filming of multiple modality DICOM images from a variety of PC client machines, using LAN or WAN networks. It also allows user selectable loss-less and lossy compression schemes that are used in order to make a trade-off between speed and quality.
AW Server is intended to be used in a manner similar to the current GE Medical Systems A W workstation product. It will be used to create and review diagnostic evidence related to radiology procedures by trained physicians in General Purpose Radiology, Oncology, Cardiology and Neurology clinical areas.
AW Server, like Advantage Workstation 4.3, may be used with a variety of other GE software medical devices, which are cleared by FDA in their own names.
The provided text describes a 510(k) summary for the GE Medical Systems' AW Server. This device is a medical software system that allows remote access to AW applications, networking, selection, processing, and filming of multimodality DICOM images. However, the document does NOT contain information about acceptance criteria or a study proving performance against such criteria.
The 510(k) submission primarily focuses on demonstrating substantial equivalence to existing predicate devices (Advantage Workstation 4.3 and AquariusNET Server) based on functional features and intended use. It highlights that the AW Server does not introduce new potential safety risks and performs comparably to devices already on the market.
Therefore, I cannot fulfill your request for: a table of acceptance criteria and reported device performance, sample sizes, data provenance, number of experts, adjudication methods, MRMC study details, standalone performance, type of ground truth, training set sample size, or how training ground truth was established.
The document states:
- "AW Server does not result in any new potential safety risks and performs as well as devices currently on the market."
- "GE considers features of the AW Server to be equivalent to predicate devices listed in section 6."
- "GE has assessed and tested this device as a software moderate Level of Concern device."
These statements suggest that the "acceptance criteria" were primarily demonstrating equivalence in functionality and safety to legally marketed predicate devices, rather than meeting specific quantitative performance metrics from a clinical study. The testing mentioned refers to "Software Development, Validation and Verification Process to ensure performance to specifications, Federal Regulations and user requirements" and "Adherence to industry and international standards," which are general quality and regulatory compliance activities, not a clinical performance study with specific endpoints as you've requested.
§ 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).