(13 days)
The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.
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 AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. 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 intended use of the device is to provide time-saving pre-processing of images to remove the need for an image review system to perform these activities while a user is waiting for processing to complete, to optimize the use of the user's time.
The AquariusAPS Server utilizes standard "off the shelf" personal computer systems as its hardware platform. The software requires the use of the Windows 2000 operating system, and a Pentium III - class processor or equivalent.
The provided text is a 510(k) Premarket Notification for the TeraRecon AquariusAPS Server. It is a regulatory document and does not contain information about acceptance criteria or a specific study designed to prove the device meets those criteria.
The document primarily focuses on:
- Device identification: Trade name, common name, classification, establishment name, and contact information.
- Substantial Equivalence: Listing equivalent devices (predicates) and claiming equivalence based on basic design, features, and intended use.
- Device Description: What the device does (receives and processes medical images, transmits derived information).
- Intended Use Statement: To provide time-saving pre-processing of images.
- Hardware & Software Information: Operating system, processor requirements, and compliance with FDA guidance for software.
- Feature Comparison Table: A table comparing the AquariusAPS Server's features to those of the predicate devices. This table highlights what features the AquariusAPS Server possesses, but it doesn't provide performance metrics or acceptance criteria for those features.
- FDA Approval Letter: Officially confirming the substantial equivalence determination.
Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because that data is not present in the provided text. The document is primarily a statement of equivalence for regulatory purposes, not a performance study report.
§ 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).