(83 days)
The LIS 6000A is intended to acquire a full resolution set of B-Mode images. The source of these images is the analog video or digital video output of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000A is intended to acquire a full resolution set of Color Flow images. The source of these images is the analog video or digital video outputs of a diagnostic ultrasound system. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000A is intended to acquire a high resolution set of B-Mode loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition geometry shall be either linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000A is intended to acquire a high resolution set of Color Flow loops. The source of these loops is the analog video or digital video output of a diagnostic ultrasound system. Gating is accomplished by analyzing externally generated cardiac and/or respiratory signals. Image acquisition excernally generator linear (parallel slice), axial (propeller slice) or sector (fan slice).
The LIS 6000 is intended to reformat the acquired B-Mode and Color Flow data sets into a single volumetric data space and subsequently display multiple planar cross sections of that space, either individually, or together in a 3D polyhedral display
The LIS 6000A is intended to display three different volumetric rendering display modes: Maximum intensity, surface rendering and volume rendering.
The LIS 6000A will make basic distance, area, and volume measurements based on boundaries defined in user selected cross sectional planes.
The LIS 6000 is a device which can acquire, display, and post process diagnostic ultrasound images.
Data acquisition involves video grabbing a set (or sets) of ultrasound frames, each frame representing a planar image, while positioning the ultrasound probe such that the set of 2D planes acquired spans a predefined volume with a known relationship between the planes. The probe positioning devices are described below. Three types of acquisitions are defined for the LIS 6000A: ungated, single phase gated and multiphase gated.
The provided document does not contain information about acceptance criteria or a study proving the device meets them. The text describes a medical device, the Life Imaging Systems LIS 6000A - Image Processing System, and its accessories, detailing its function, acquisition methods, post-processing capabilities, and intended uses. It also includes a comparison table with a predicate device, the TomTec EchoScan.
Therefore, it is not possible to provide the requested information, including:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or the effect size.
- Whether a standalone performance study was done.
- The type of ground truth used.
- The sample size for the training set.
- How the ground truth for the training set was established.
§ 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).