(43 days)
The AS-OBGYN Information System is intended to automate the management of patient information. The system allows image acquisition, review, document, storage, archive and reporting.
The AS-OBGYN Information System is intended for use by obstetricians, gynecologists, perinatologists, radiologists and cardiologists. The system is designed for use in hospitals and medical offices.
The AS-OBGYN Information System consists of robust and comprehensive patient information. The system allows the management of patient clinical data and image management (communication, review, storage and archiving). The system provides the capability to edit patient information and clinical data as well as the generation of electronic and printed reports. The device is available in a variety of configurations depending on specific requirements.
The AS-OBGYN Information System communicates with DICOM modalities devices. In the case of DICOM sessions the communication is handled through the AS-DICOM Server package (for TCP/IP connections). For non-DICOM sessions, the communication is handled through the AS-COMM package (for TCP/IP, RS-232 and USB connections). The AS-OBGYN Information System receives single and multi-frame images from devices over the network using the DICOM communication, while additional descriptive data may be received through DICOM session or non-DICOM sessions.
All the hardware used by AS-OBGYN Information System (including computers, storage drives, network interface, monitor and printer) is commercial off-the-shelf equipment.
The provided text is a 510(k) summary for the AS-OBGYN Information System. It describes the device, its intended use, and substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets those criteria based on the provided input.
This 510(k) summary focuses on demonstrating substantial equivalence to existing devices, which is a common pathway for medical device clearance, especially for information systems. It doesn't typically require extensive clinical performance studies in the same way a novel diagnostic or therapeutic device might. The "performance" in this context is likely related to its functionality as an information system (e.g., ability to acquire, review, store, and report data), which would be assessed through software verification and validation, rather than clinical efficacy or accuracy metrics against a ground truth.
§ 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).