(14 days)
RA600/CA1000/Digital Hardcopy is intended for viewing and diagnostic interpretation of images acquired from CT, MR, CR, DR, US, XA and other DICOM-compliant medical imaging systems when installed on suitable commercial-standard PC hardware. RA600 / CA1000 is intended for use as a primary diagnostic and analysis workstation in Radiology/ Cardiology or other departments. It is also intended for use as a clinical review workstation throughout the healthcare facility and may be part of a larger PACS configuration.
Digital Hardcopy is intended for use primarily as a workstation for the high volume burning of CDs or DVDs containing DICOM medical images and associated diagnostic report or analysis information. CD /DVD burning and disk labeling are done via a commercially available external robotics device.
RA600/CA1000/Digital Hardcopy receives imaging studies and data over LAN, WAN, intranet or internet from a PACS server or directly from a DICOM -compliant modality or archive utilizing both lossless and lossy compression. It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application. The RA600/CA1000/Digital Hardcopy may interface with various information systems within the healthcare environment, such as the HIS, RIS, and CVIS. It may be sold as software only, or as a turnkey system.
Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy workstation is a PC-based DICOM workstation platform which provides scaleable image and data management solutions for medical imaging. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data. RA600/CA1000 / Digital Hardcopy may be combined with a PACS network or connected directly to a modality through the use of DICOM networking. The RA600/CA1000 / Digital Hardcopy software application may be sold as a standalone product for use with 'off the shelf' PC hardware that meets minimum specifications or as a turnkey solution integrated with hardware components to be configured to meet the users specific needs. RA600 / CA1000 / Digital Hardcopy can also provide the hardware and OS platform for a user to operate 3rd party software and/or other GE software applications such as RIS, voice recognition, or advanced imaging analysis, and view any data presented through those applications. RA600 / CA1000 can act as an image repository for the Centricity Web Viewer application.
The provided text does not contain specific acceptance criteria or a detailed study proving device performance against such criteria. Instead, it describes a 510(k) submission for a Picture Archiving and Communications System (PACS) workstation, focusing on its intended use, technology, and compliance with general quality assurance measures, rather than a clinical performance study with quantitative results.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the given text. The document refers to "voluntary standards as detailed in Section 9 of this submission" and mentions various quality assurance measures (Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Final Acceptance Testing, Performance Testing, Safety Testing). However, it does not specify what those standards are, what the acceptance criteria for those standards were, or the quantitative performance results of the device against those criteria.
2. Sample size used for the test set and the data provenance:
This information is not provided. The text mentions "Testing on unit level," "Integration testing," "Final acceptance testing," and "Performance testing" but does not detail the test set used for these activities, its size, or its provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document describes the intended users as "trained professionals, including radiologists, cardiologists, physicians, technologists and nurses," but does not mention the involvement of experts in establishing ground truth for any testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This information is not provided, and it's highly unlikely such a study would be relevant for this type of device (a PACS workstation) with the given context. The device described is a platform for viewing and managing medical images, not an AI-powered diagnostic tool. The focus is on functionality and compatibility, not diagnostic accuracy enhancement via AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided, and again, it's not applicable in the context of this device. The device itself is a workstation used by humans, not a standalone algorithm performing diagnostic tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. As no specific diagnostic performance study is mentioned, the concept of "ground truth" in that context is not discussed. Compliance with "voluntary standards" would imply adherence to functional and safety requirements, not clinical diagnostic accuracy against a ground truth.
8. The sample size for the training set:
This information is not provided. The device is a software application for managing and displaying medical images, not a machine learning model that requires a training set in the conventional sense.
9. How the ground truth for the training set was established:
This information is not provided, for the same reason as point 8.
In summary:
The provided document is a 510(k) summary for a PACS workstation. It focuses on demonstrating substantial equivalence to predicate devices and adherence to general quality assurance and safety standards. It does not present a clinical performance study with specific acceptance criteria, quantitative results, or details about test sets, ground truth establishment, or expert involvement in the way a diagnostic AI device submission would. The "study" mentioned consists of internal quality assurance measures and performance/safety testing, without providing the quantitative details requested.
§ 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).