(39 days)
The GE ViewPoint is intended to accept, transfer, display, store and process medical images and data, including the ability to measure, calculate, annotate and prepare and print patient examination reports primarily for diagnostic ultrasound.
GE ViewPoint is a software based medical image management system providing the ability to review exam images and data, prepare and printing reports and communicate with ultrasound scanners and other PACS devices via DICOM or other network protocol. It is sold with or without the designated computer hardware.
This document is a 510(k) premarket notification for the GE ViewPoint Image Management and Reporting System, submitted on April 12, 2005. It provides general information about the device and asserts its substantial equivalence to a predicate device. However, it does not contain any specific acceptance criteria or details of a study demonstrating the device meets such criteria in terms of performance metrics.
The document explicitly states:
- "Clinical Tests: None required to confirm safety and effectiveness. However, evaluation in a clinical setting is performed to help assure reliability and compatibility within the intended network environment."
Therefore, based solely on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence based on intended use and technological characteristics to a predicate device, not on specific performance metrics against defined acceptance criteria.
- Sample sizes used for the test set and data provenance: Not applicable as no performance testing study against acceptance criteria is described.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Summary based on the provided document:
The GE ViewPoint system is described as a software-based medical image management system designed to accept, transfer, display, store, and process ultrasound images and data. It allows for measurement, calculation, annotation, and preparation/printing of patient examination reports.
The manufacturer asserts that the device is substantially equivalent to the KinetDx® Diagnostic Workstation for Radiology (K041029). The basis for this equivalence is stated to be:
- Equivalent technological characteristics
- Key safety and effectiveness features
- Physical design, construction, and materials
- Essentially the same intended uses
The submission highlights non-clinical tests for conformance to design specifications and software development, and system compatibility. It also mentions an evaluation in a clinical setting "to help assure reliability and compatibility within the intended network environment," but explicitly states that clinical tests were "None required to confirm safety and effectiveness."
Therefore, the document relies on the concept of substantial equivalence to a legally marketed predicate device rather than demonstrating performance against specific acceptance criteria through a detailed study.
§ 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).