(83 days)
ViewPoint 6 is intended to be used in medical practices and in clinical departments and serves the purposes of diagnostic interpretation of images, electronic documentation of examinations in the form of text and images, and generation of medical reports primarily for diagnostic ultrasound.
ViewPoint 6 provides the user the ability to include images, drawings, and charts into medical reports. ViewPoint 6 is designed to accept, transfer, display, calculate, store, and process medical images and data, and enables the user to measure and annotate the images. The medical images, which ViewPoint 6 displays to the user, can be used for diagnostic purposes.
ViewPoint 6 is intended for professional use only. ViewPoint 6 is not intended to be used as an automated diagnosis system.
ViewPoint 6 is not intended to operate medical devices in surgery related procedures.
ViewPoint 6 is an image archiving and reporting software for medical practices and clinical radiological departments. It is used for diagnostic interpretation of images and other data. It provides different calculations and tools to allow for the assessment of the images and data.
ViewPoint 6 is for professional use only and enables quick diagnostic reporting with standardized terminology. It has an intuitive graphical user interface (GUI) and is based on Microsoft Windows® with defined hardware requirements for the user to install on their computer.
ViewPoint 6 provides exam type specific reporting forms for various medical care areas. Forms are composed of different sections with data entry fields. The documentation can include measurements, exam findings, images, and graphs. All data is saved in the ViewPoint 6 database and can be compiled to a professional report. Images and image sequences can be reviewed in the ViewPoint 6 display area based on user preference.
ViewPoint 6 supports both a single workstation and a client - server setup. The number of user licenses determines how many workstations in the network have concurrent access to the database. Access can be limited to read - only functionality.
This FDA 510(k) summary for GE Healthcare's ViewPoint 6 software does not contain the detailed information necessary to complete the requested table and answer the study-related questions. The document states that no clinical studies were required to support substantial equivalence (Page 6).
Therefore, I cannot provide:
- A table of acceptance criteria and the reported device performance: This information is derived from clinical studies, which were not performed.
- Sample size used for the test set and the data provenance: No clinical test set was described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth for a test set was established as no clinical test was conducted.
- Adjudication method for the test set: Not applicable as no test set was used.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, the document explicitly states no clinical studies were required.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as no algorithm performance study was described. ViewPoint 6 is described as an image archiving and reporting software, not an automated diagnostic algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Based on the provided document, the ViewPoint 6 device is a Picture Archiving and Communication System (PACS) software tool. The 510(k) submission for ViewPoint 6 relied primarily on non-clinical tests and a comparison to predicate devices, rather than clinical performance studies, to demonstrate substantial equivalence.
The document states:
- "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." (Page 6)
- "GE Healthcare considers the ViewPoint 6 to be as safe, as effective, and performance is substantially equivalent to the predicate devices." (Page 6)
- The determination of substantial equivalence was based on "intended use, capabilities, technological characteristics, safety and effectiveness" compared to predicate devices (ViewPoint 6, K173456, and reference devices Voluson E10, K192159 and Versana Balance, K191792). (Page 5)
- The summary focuses on "Non-Clinical Tests" such as compliance with voluntary standards (IEC 62366-1, IEC 62304, NEMA PS 3.1-3.20 DICOM, ISO 14971, IEC 82304-1) and quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, various levels of testing). (Pages 5-6)
Therefore, the requested information regarding acceptance criteria and performance data from a clinical study cannot be extracted from this document, as no such study was conducted or presented in this 510(k) summary.
§ 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).