(85 days)
Centricity* Cardio Imaging is a software only Picture Archiving and Communication System (PACS). It will be sold as a software only device to operate on general purpose computing hardware. Centricity* Cardio Imaging receives medical images and other information from various data sources. Information can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Centricity* Cardio Imaging is intended to assist trained professionals in the viewing, analysis, and diagnostic interpretation of images and other information for the diagnosis and treatment of cardiac and vascular disease. These trained professionals include but are not limited to physicians, cardiologists, radiologists, nurses, medical technicians, and assistants.
Centricity* Cardio Imaging is a web enabled cardiology Picture Archiving and Communication System that offers highly integrated imaging, workflow and information management in a single platform. Centricity* Cardio Imaging leverages a rich ECHO/NIPV clinical toolset and the data management capability from its predicate devices.
Centricity* Cardio Imaging is a software only medical device comprised of a client and server. The client is web-accessed and provides the user-facing functions such as the work list, viewing, and reporting. The server provides background functions such as data storage, data transfer, database management, application deployment, user authentication, user profiles, licensing, and hanging protocols.
Centricity* Cardio Imaaina is a software only medical device intended for use with commercially available off the shelf hardware.
The provided 510(k) summary for GE Healthcare's Centricity Cardio Imaging does not contain information about specific acceptance criteria or a study proving that the device meets such criteria.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Centricity PACS-IW and TomTec Imaging System's Image Arena) based on fundamental scientific technology, intended use, and general performance (receiving, storing, communicating, processing, and displaying images).
Here's why the requested information is absent:
- No Clinical Studies Required: The "Summary of Clinical Tests" explicitly states: "The subject of this premarket notification submission, Centricity* Cardio Imaging, did not require clinical studies to support substantial equivalence." This means no clinical performance data was generated or submitted for this device to prove it meets specific performance metrics.
- Focus on Substantial Equivalence: The primary objective of this 510(k) submission is to show that the new device is as safe and effective as a legally marketed predicate device. This is often achieved by demonstrating similar technology, intended use, and performance characteristics, without necessarily conducting new effectiveness studies against predefined acceptance criteria.
- Quality Assurance Measures: The document lists "non-clinical tests" such as Risk Analysis, Requirements Reviews, Design Reviews, and various levels of testing (unit, integration, performance, safety, simulated use). These are general quality assurance and verification/validation activities for software development, ensuring the software functions as designed, but they are not presented as a "study" with specific performance acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance data from the provided text.
Based on the document, I can only state the following:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Not explicitly stated as performance criteria for equivalence) | Reported Device Performance (as implied by nature of 510k submission) |
|---|---|
| No explicit performance-based acceptance criteria are provided in the document. | - Operates as a web-enabled cardiology Picture Archiving and Communication System (PACS). |
- Offers highly integrated imaging, workflow, and information management.
- Leverages ECHO/NIPV clinical toolset and data management capability.
- Receives, stores, communicates, processes, and displays medical images and other information from various data sources.
- Intended to assist trained professionals in viewing, analysis, and diagnostic interpretation.
- Complies with voluntary standards (not specified).
- Underwent risk analysis, requirements reviews, design reviews, unit testing, integration testing, performance testing, safety testing, and simulated use testing. |
2. Sample size used for the test set and the data provenance: Not provided, as no clinical study was conducted. Non-clinical testing data provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was conducted.
4. Adjudication method for the test set: Not applicable, as no clinical study was conducted.
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 a PACS system, not an AI-assisted diagnostic tool, and no clinical study (including MRMC) was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a PACS system, not a standalone diagnostic algorithm, and no clinical performance testing was explicitly described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no clinical study was conducted. For non-clinical validation (simulated use testing), the "ground truth" would have been defined by the expected system behavior and output specifications.
8. The sample size for the training set: Not applicable, as no machine learning/AI training data is mentioned. The device is a PACS.
9. How the ground truth for the training set was established: Not applicable, as no machine learning/AI training data is mentioned.
§ 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).