(24 days)
Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image.
4D View is a standalone Software product. which can be installed on a Laptop/PC with Microsoft Windows 7, Windows 8 and as virtual machine with Windows 7 on MAC operating systems. Primary Operating Functions are:
• Display and editing of 3D/4D data sets
• Measurements on displayed image incl. derived calculations based on medical literature in the following applications: Abdominal, Obstetrics, Gynecology, Cardiology, Urology, Vascular, Neurology, Small Parts, Pediatrics, Musculo-Skeletal (Orthopedics).
• Data storage (image, measurement and patient data)
• Data transfer to and from remote systems (e.g. via DICOM)
• Adding annotations to acquired image
The provided text is a 510(k) Premarket Notification Submission for GE Healthcare's 4D View software. This document primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain information about acceptance criteria, device performance, or specific clinical studies in the way a medical device validation study typically would.
Therefore, based on the provided text, I cannot provide the detailed information requested in your prompt.
Here's why and what the text does say:
- No Acceptance Criteria or Device Performance Metrics: The document states, "The subject of this premarket submission, 4D View, did not require clinical studies to support substantial equivalence." This means it wasn't a submission based on demonstrating specific performance against predefined clinical criteria through a new study. Instead, it relied on demonstrating that its fundamental technology, intended use, and safety/effectiveness are the same as an already cleared device.
- No Clinical Study Details: Since clinical studies were not required for this submission, there is no information on sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for training sets.
- Focus on Substantial Equivalence: The document highlights that the 4D View "employsthe same fundamental scientific technology as its predicate device(s)" and that "The Intended Use and Indications for use have not changed from the unmodified device." The modifications introduced are the "ability for 4D View to work with additional GE Ultrasound features and data."
What the document does provide:
- Predicate Device: K101166 4D View and K122327 GE Voluson E6/E8/E8ExpertE10 Diagnostic Ultrasound System.
- Voluntary Standards Compliance: IEC62304, ISO14971, NEMA DICOM Set.
- Quality Assurance Measures: Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Performance Testing, Safety Testing, Final Acceptance Testing. These are general software development and quality control processes, not performance metrics for the device itself.
- Intended Use: "Image Display of 3D/4D data sets for diagnostic purposes including measurements on displayed image."
To answer your prompt directly, an 510(k) summary for a substantial equivalence determination often does not include the detailed performance criteria and study results you are asking for, especially when clinical studies are not deemed necessary. Such details are more common in PMA (Premarket Approval) applications or 510(k)s where novel technology or new indications require new clinical evidence.
§ 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).