(47 days)
Encompass.Net™ device is software intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US and other DICOM compliant medical imaging systems when installed on suitable commercial standard hardware. Encompass.Net™ receives imaging studies over a network from Empiric Systems servers or directly from CD with images utilizing both lossless (reversible) and lossy (irreversible) compression.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. 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.
It is the User's responsibility to ensure monitor quality, ambient light conditions, and image compression ratios are consistent with clinical application.
Encompass.Net™ is a fully web-based system that operates in a Microsoft Internet Explorer (Version 6.0 and above) environment. Encompass.Net™ is run in a Windows 2003 environment, using Microsoft's Internet Information Server functions. The core database is Microsoft SQL 2000.
Encompass. Net is intended to acquire medical images for storage, archiving, and routing to medical professionals. In addition, Encompass.Net allows medical professionals to retrieve medical images on demand using Internet communication protocols according to various user options and lossy and/or lossless compression techniques for subsequent review. A host of image process tools are available for the medical professional.
In addition to Encompass. Net, the fully integrated RIS/PACS device, there are also multiple stand-alone PACS models (subsets of Encompass Net) that will be marketed. Those configurations are: R1.Net, R2.Net, and R3.Net.
The provided text is a 510(k) summary for the Encompass.Net™ device, which is a Picture Archiving Communications System (PACS). It describes the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain any information about specific acceptance criteria or a study proving the device meets them.
The document is primarily a regulatory submission to the FDA for market clearance, focusing on:
- Device Description: Encompass.Net™ is a fully web-based system for acquiring, storing, archiving, routing, and retrieving medical images (CT, MR, CR, DR, US, and other DICOM compliant systems) for viewing and diagnostic interpretation. It supports both lossless and lossy compression.
- Indications for Use: Viewing and diagnostic interpretation of images from various medical imaging systems, with specific caveats for mammographic images (lossy compressed mammograms and digitized film-screen images) which must not be reviewed for primary interpretation, and requiring FDA-approved monitors for mammography.
- Technological Characteristics: It's a software product that handles digital medical images and does not contact the patient or control life-sustaining devices.
- Predicate Device: Amicas Light Beam Workstation (K022970).
- Conclusion: The submission aims to demonstrate substantial equivalence to the predicate device.
Therefore, I cannot provide the requested information about acceptance criteria or a study with performance data because it is not present in the provided text. The document does not describe a clinical performance study using test sets, ground truth, or expert readers. It appears to be a review of technical and functional equivalency rather than clinical efficacy or accuracy.
§ 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).