(60 days)
EchoNet is software which runs on Unix workstations. EchoNet is intended to be used for storing and displaying digital imaqes acquired by digital ultrasound imaging systems. EchoNet provides rapid network access to the imagery and patient demographic data stored on a central server. The system retrieves and stores images as unaltered computer data and as JPEG (Joint Photographic Experts Group) lossy compressed cine-loops. This dual-path storage system allows for rapid access to high quality compressed images with the original unaltered (losslessly compressed) images available on demand. EchoNet is a scalable network system designed to service customers ranging in size from small departments (with 2 or 3 users) to large hospital networks (with tens of users).
EchoNet is composed of the following: Unix workstation which permits review and diagnosis of EchoNet Client: ultrasound imagery and demographics. This review software provides basic controls such as play/pause, image contrast/brightness and image scaling. The system is capable of displaying two types of stored imagery. High quality JPEG compressed (Q-Factor 75 compression ratio approximately 15 to 1) digital cineloops and unaltered digital cine-loops. The JPEG images are intended for preview and preliminary assessment while the original data is always available on demand. EchoNet Server: Unix workstation based database and image server software combined with a virtual file system. The server is a central archive for imagery and patient information. The EchoNet server may be configured with a variety of mass storage devices. These devices such as hard-disks, optical juke-box libraries and tape libraries provide on-line and archival storage of images.
The provided 510(k) summary for EchoNet, designated K960946, does not contain any information regarding acceptance criteria or a study proving the device meets such criteria.
The document primarily focuses on:
- Product Identification: Trade name (EchoNet), common name (unknown), classification name (device, digital image storage), manufacturer, contact, and date prepared.
- Indications for Use: Storing and displaying digital images acquired by digital ultrasound imaging systems, providing network access, storing unaltered and JPEG compressed cine-loops for preview/preliminary assessment and original data access on demand.
- Device Description: Composed of an EchoNet Client (Unix workstation for review and diagnosis, with basic controls and display of JPEG compressed and unaltered cine-loops) and an EchoNet Server (Unix workstation based database and image server software with a virtual file system for central archive and various mass storage options).
- Marketing History: Stating it's identical to the Heartlab EchoNet product (K954860).
- Potential Adverse Effects on Health: Stating concerns are controlled by FMEA.
- Conclusions: Stating "This system poses no added risk to safety."
Therefore, it is impossible to complete the requested table and provide the detailed study information using only the provided text. The document describes a digital image storage and display system, not a device that makes diagnostic or clinical determinations requiring performance metrics like sensitivity, specificity, or reader studies. Its "performance" is implicitly related to its functionality in storing, retrieving, and displaying images accurately, which would typically be verified through software validation and verification testing, not clinical studies with acceptance criteria as envisioned in the prompt.
§ 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).