(31 days)
To retrieve and display for reading, diagnostic review, analysis and measurement of digital medical images acquired from DICOM compliant acquisition systems such as CT, MR, PET, X-ray and Ultrasound. Also, for images acquired from GE LOGIQ ultrasound, to process, analyze and manipulate images with the same post acquisition capability as that provided on the GE LOGIQ ultrasound scanner.
The GE LOGIQ Works Image Analysis and Review Workstation is optimized for ultrasound images that are acquired primarily via the GE LOGIQ family of diagnostic ultrasound systems. It is sold with or without the designated computer hardware.
The GE LOGIQ Works Ultrasound Workstation is a medical image management device designed for retrieving, displaying, and processing diagnostic medical images.
Here's an analysis of its acceptance criteria and the supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Section in Document |
|---|---|---|---|
| System Functionality | Conformance to design specifications | Device has been evaluated for conformance to its design specifications | Section b): 1. Non-clinical Tests |
| Industry Standards | Conformance to applicable industry standards for software development | Device has been evaluated for conformance to applicable industry standards for software development | Section b): 1. Non-clinical Tests |
| System Compatibility | Verification of system compatibility with communicating devices | Device is further verified for system compatibility with the devices with which it communicates | Section b): 1. Non-clinical Tests |
| Hardware Safety | Certification of computer hardware to applicable safety standards | Computer hardware is certified to applicable safety standards | Section b): 1. Non-clinical Tests |
| Quality Systems | Conformance to quality systems | The design and development process conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems | Section b): 3. Conclusion |
| Medical Device Safety | Conformance to applicable medical device safety standards | Device conforms to applicable medical device safety standards and compliance is verified through internal and independent quality system audit | Section b): 3. Conclusion |
| Substantial Equivalence | Equivalence to cleared predicate devices regarding safety and effectiveness | It is the opinion of GE Healthcare that the GE LOGIQ is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market. | Section b): 3. Conclusion |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a specific test set, sample size, or data provenance (country of origin, retrospective/prospective) for evaluating the functionality or performance of the GE LOGIQ Works Ultrasound Workstation. The submission primarily focuses on non-clinical tests related to design, standards, and compatibility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. No clinical test set or ground truth establishment by experts is mentioned for this device. The submission explicitly states "Clinical Tests: None required to confirm safety and effectiveness."
4. Adjudication Method for the Test Set
Not applicable. As no clinical test set is described, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document does not describe any MRMC comparative effectiveness study, nor does it discuss human reader improvement with or without AI assistance. The device is a workstation for image management and processing, not an AI-powered diagnostic tool.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is an image processing and review workstation, not an algorithm requiring standalone performance evaluation in a diagnostic context. Its performance is related to its ability to display, process, and manage images as intended, which is covered by non-clinical tests.
7. Type of Ground Truth Used
Not applicable. As clinical tests were not required and no diagnostic claims are being made that would necessitate comparison to a specific ground truth (like pathology or outcomes data), no "ground truth" as typically understood in diagnostic device evaluation was used. The ground for its "effectiveness" is its ability to perform its defined functions (display, process, analyze) in accordance with its specifications.
8. Sample Size for the Training Set
Not applicable. This device, a medical image management workstation, does not utilize machine learning or AI models that would require a "training set" in the conventional sense. Its functionality is based on established software engineering principles and image processing algorithms.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for this type of device, no ground truth for a 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).