(101 days)
ViewPoint 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 provides the user the ability to including images, drawings, and charts into medical reports. ViewPoint 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 displays to the user, can be used for diagnostic purposes.
ViewPoint is intended for professional use only. ViewPoint is not intended to be used as an automated diagnosis system.
ViewPoint is not intended to operate medical devices in surgery related procedures.
GE ViewPoint 6 is an-image-archiving and reporting software for medical practices and clinical radiological departments used for diagnostic purpose. It incorporates basic features of administration, image and data acquisition from medical devices via DICOM or proprietary interface, data transfer from third party systems, reporting of medical findings, report generation, network interfacing and archiving. Image processing and calculations capabilities are available for images.
The basis for this submission is a modification to a legally marketed device to incorporate additional features and to modify the wording of the indications for use statement for clarification purposes. The proposed indications for use statement is equivalent to the one from the predicate device. The intended use is identical to the predicate device.
The device modifications mainly consist of:
- Enhancements to the User Interface for improved usability;
- Additional customization capabilities;
- Configurable User Interface language.
The provided document is a 510(k) Premarket Notification for GE Healthcare's ViewPoint 6, an image archiving and reporting software for medical practices and clinical radiological departments. The document focuses on demonstrating substantial equivalence to a predicate device (ViewPoint 5) and does not describe a study involving AI or specific acceptance criteria for a device's performance in terms of diagnostic accuracy or a similar clinical metric.
Therefore, many of the requested details, such as a table of acceptance criteria and reported device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable or not available in this document.
Here's what can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable / Not available. The document states that ViewPoint 6 did not require clinical studies. The "acceptance criteria" here are related to regulatory compliance and demonstrating substantial equivalence to a predicate device, rather than specific performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic AI device. The study performed involved non-clinical tests to verify compliance with voluntary standards and ensure quality assurance.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not available. As no clinical studies were performed, there is no test set in the context of diagnostic performance evaluation. The "tests" mentioned are for software verification and validation (e.g., unit, integration, performance, safety, simulated use testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable / Not available. No ground truth for diagnostic performance was established for a test set as no clinical studies were performed.
4. Adjudication Method for the Test Set:
- Not applicable / Not available.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:
- Not applicable. This device is an image archiving and reporting software, not an AI-powered diagnostic tool for assisting human readers. The document explicitly states it "is not intended to be used as an automated diagnosis system."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is software for image management and reporting, not a standalone diagnostic algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No clinical ground truth was established for diagnostic performance. The "ground truth" in the context of this submission refers to the successful completion of software development lifecycle activities and adherence to established standards and requirements for software functionality and safety.
8. The Sample Size for the Training Set:
- Not applicable / Not available. This is not an AI/machine learning device that relies on a training set for model development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable / Not available.
Summary of the Study and Device Information (as per document):
- Device Name: ViewPoint 6
- Device Type: Image archiving and reporting software for medical practices and clinical radiological departments.
- Intended Use: "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." It also explicitly states: "ViewPoint is not intended to be used as an automated diagnosis system."
- Study Performed: Non-clinical tests were conducted to comply with voluntary standards and apply quality assurance measures to the development of the system. These included:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- Safety testing (Verification)
- Simulated use testing (Validation)
- Conclusion of Study: "The subject of this premarket submission, ViewPoint 6, did not require clinical studies to support substantial equivalence." The non-clinical tests were deemed sufficient to demonstrate that ViewPoint 6 is as safe, as effective, and its performance is substantially equivalent to the predicate device (ViewPoint 5).
In essence, the ViewPoint 6 submission is for a software update to an existing PACS (Picture Archiving and Communications System) type device, not for an AI diagnostic device. Its regulatory pathway leveraging substantial equivalence to a predicate device and focusing on non-clinical software testing reflects its classification and intended use as a medical image management system, not a device making diagnostic interpretations.
§ 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).