(36 days)
The Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
The Centricity PACS Workstation software is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility.
The Centricity PACS provides scalable image and data management solutions for medical imaging modalities, such as Computed Tomography (CT). Magnetic Resonance (MR), Computed Radiography (CR), Digital X-Ray (DX), Digital Mammography (MG), Ultrasound (US), Nuclear Medicine (NM), Positron Emission Tomography (PET), X-Ray Angiography (XA), Oral X-Ray (IO), Endoscopic Video (ES), and any other DICOM devices.
The workstation interface software provides the user with a means to display, manipulate, archive, print, and export images when connected with the Centricity PACS infrastructure.
To be viewed for primary interpretation, the digital mammography images must be acquired from an FDA approved Full Field Digital Mammography (FFDM) device for primary interpretation. Furthermore, the FFDM must be able to provide, to the Centricity PACS, a viewable DICOM 'for presentation' mammography image as approved by the FDA for primary interpretation. Images that are printed to film must be printed using a FDA approved printer for the diagnosis of digital mammography images.
To be viewed for primary diagnosis, digital mammography images must be viewed on a display system that has been cleared by the FDA for the diagnosis of digital mammography images.
The Centricity PACS allows integration with other open interfaces, such as DICOM. to web client products and archive devices.
The Centricity Infrastructure software provides for the system's database and image management, printing, HL-7 interfacing, and all DICOM services including but not limited to, Store, Print, Query/Retrieve, and Send.
It is the user's responsibility to ensure quality, ambient light conditions, and image compression ratios are consistent with the clinical application.
Centricity PACS is an enterprise grade Picture Archiving and Communications System (PACS) for managing digital medical images and associated data. Centricity PACS enables the storage, retrieval, distribution, printing, and presentation of images acquired from diagnostic imaging modalities.
Centricity PACS is a standards-based, customizable, and scalable solution supporting several of the Integrating the Healthcare Enterprise (IHE) profiles, Digital Imaging and Communications in Medicine (DICOM), and the Health Level Seven (HL7) protocol standards for managing digital medical images and patient data. Centricity PACS supports radiographic imaging-as in clinical radiography, cardiology, dentistry, and mammography and non-radiologic imaging, including video support.
Centricity PACS v3.2.1 employs the same fundamental scientific technology as its predicate devices, however v3.2.1 is a software only product.
This GE Healthcare Centricity PACS submission (K110875) describes a Picture Archiving and Communication System (PACS) software product. As such, the submission does not contain information about the performance of an AI/ML algorithm.
Here's a breakdown of the information available based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, there are no specific performance-based acceptance criteria or reported device performance metrics in the provided text. The device's "performance" is primarily tied to its functionality as a PACS system.
The acceptance criteria referenced are related to quality assurance measures during development:
| Acceptance Criteria (Quality Assurance) | Reported Device Performance |
|---|---|
| Risk Analysis | Complies with voluntary standards; Applied to development |
| Requirements Reviews | Applied to development |
| Design Reviews | Applied to development |
| Testing on unit level (Module verification) | Applied to development |
| Integration testing (System verification) | Applied to development |
| Performance testing (Verification) | Applied to development |
| Safety testing (Verification) | Applied to development |
| Simulated use testing (Validation) | Applied to development |
2. Sample Size Used for the Test Set and Data Provenance:
No test set for evaluating specific device performance (e.g., diagnostic accuracy) is mentioned because clinical studies were not conducted. The "testing" mentioned refers to software development and validation activities.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as no clinical studies requiring ground truth establishment were conducted.
4. Adjudication Method:
Not applicable, as no clinical studies requiring adjudication were conducted.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done, as the submission explicitly states that clinical studies were not required. The device is a PACS system, not an AI-assisted diagnostic tool in the context of this submission.
6. Standalone (Algorithm Only) Performance Study:
Not applicable, as this device is a PACS system and the submission does not detail any specific AI/ML algorithms or their standalone performance.
7. Type of Ground Truth Used:
Not applicable, as no clinical studies requiring ground truth were conducted.
8. Sample Size for the Training Set:
Not applicable, as the submission does not describe the development or training of an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as the submission does not describe the development or training of an AI/ML algorithm.
Summary of the Study:
The "study" described in this 510(k) submission is primarily a non-clinical study focusing on design and quality assurance processes to demonstrate substantial equivalence to a predicate device (K043415 Centricity™ PACS).
The key points of the study are:
- Objective: To demonstrate that Centricity PACS v3.2.1 is substantially equivalent to its predicate device (K043415 Centricity™ PACS).
- Methodology: The submission relies on a comparison of technological characteristics and adherence to quality assurance measures during device development.
- Demonstration of Substantial Equivalence: The applicant argues that the proposed device employs the "same fundamental scientific technology" as its predicate and complies with voluntary standards. They performed various risk analyses, reviews, and testing (unit, integration, performance, safety, and simulated use testing) as part of their quality assurance process.
- Conclusion: GE Healthcare concludes that Centricity PACS is as safe, as effective, and its performance is substantially equivalent to the predicate device, thus not requiring clinical studies.
In essence, this 510(k) is for a software update to an existing PACS system, and the "study" is a collection of engineering and quality management documentation rather than a clinical trial or AI performance study.
§ 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).