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The Centricity™ PACS provides scaleable image, data management and storage solutions for medical imaging. The system 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 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), and any other DICOM devices.

The Centricity™ PACS Workstation 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 workstation interface 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 Web client software allows the user to display and manipulate images stored in the Centricity™ PACS or other DICOM archive device including the Centricity™ Enterprise Archive. The Centricity™ Web is not intended for primary diagnosis.

The Centricity™ Infrastructure provides for the system's database management, storage, printing, HL-7 interfacing, and all DICOM services such as Store, Print, Query/ Retrieve, Send, etc.

It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

The Centricity™ PACS include the following major components: Workstation, Web Client, and Infrastructure.

The Centricity™ PACS workstation is used to view, edit, manipulate, annotate, analyze, store and distribute images and data that are stored and managed in the Centricity™ PACS infrastructure for diagnosis. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.

All acquired image data is preserved in the format in which it is received. Changes may be made to the presentation of the images. These changes are saved as display definitions only and do not alter the acquired image pixel data. Any and all display definitions applied to an image can always be reversed to the acquired state.

The Centricity™ PACS workstation may also be used in a remote location, away from the healthcare facility, as long as the workstation has the ability to connect, via network, to the primary healthcare facility where the Centricity™ PACS infrastructure is located.

The Centricity™ PACS Workstation extends its diagnostic and productivity capabilities into the mammography reading environment and may also be used for the primary interpretation of digital mammography images.

The Centricity™ PACS Workstation can also provide the hardware and OS platform for users to integrate and operate 3rd party software and/or other GE software applications such as RIS, voice recognition, or advanced imaging analysis (for example 3D reconstruction, MIP/MPR, and bone templating, etc.) and view any data presented through those applications.

The Centricity™ PACS Workstation software application may be sold as software only for use with 'off the shelf' PC hardware technology that meets defined minimum specifications or as a turnkey solution integrated with hardware components to be configured to meet the users specific needs

The Centricity™ Web is an internal and external image and information distribution system for the clinical review of medical images and reports. The Centricity™ Web is not intended for primary diagnosis. The Centricity™ Web is available as a supplemental sub-system to Centricity™ PACS or as a standalone Web-based image and information distribution system.

The Centricity™ PACS Infrastructure consists of a combined set of servers and software applications, which together with the Centricity™ PACS workstation and the Centricity™ Web, make up the Centricity™ PACS.

Centricity™ Enterprise Archive delivers a complete, scalable storage solution for diagnostic images. Images can be stored in uncompressed, lossless, lossy or in Wavelet/Multi-resolution formats. The system also has the ability to send data to DICOM ready devices via the DICOM standard protocol. It is a DICOM compliant solution for image storage, retrieval and transmission. The Enterprise Archive provides redundancy in long-term storage in several ways, including Redundant Archives, Media Copy, and Application Service Provider (ASP) Archive.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Centricity™ PACS System.

It's important to note that this document is a 510(k) summary from 2004, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with quantitative acceptance criteria in the way a modern AI/CAD device submission might. This summary primarily emphasizes functional equivalence and adherence to voluntary standards and internal quality processes.

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format as might be expected for an AI-driven device's clinical performance study. Instead, it relies on demonstrating that the Centricity™ PACS System "is as safe, as effective, and performs as well as the predicate devices." The core of the "study" described is a declaration of compliance with voluntary standards and the application of internal quality assurance measures during development.

Implied Acceptance Criteria and Reported Performance:

Study Details (Based on the Provided Text)

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly mentioned. The document describes compliance with voluntary standards and internal quality assurance measures (unit testing, integration testing, final acceptance testing, performance testing, safety testing). These imply testing activities, but no specific external test set size or characteristics (e.g., number of images, cases) are provided.
   • Data Provenance: Not specified. The document outlines that the system handles various modalities (CT, MR, CR, DX, MG, US, NM, PET, XA, and any other DICOM devices). However, it does not detail the origin (e.g., country of origin, retrospective/prospective collection) of any data used for testing or evaluation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified. The document does not describe a clinical study involving human readers or the establishment of ground truth by experts for the purpose of validating the system's diagnostic accuracy. Its focus is on functional equivalence and system interoperability.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable/Not specified. Since no clinical test set or ground truth establishment by experts is described, no adjudication method is mentioned.

4. 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:

   • No. The document predates the widespread regulatory requirement for rigorous MRMC studies for AI/CAD devices. This 510(k) summary is for a PACS system, which is a viewing and archiving system, not an AI/CAD-driven diagnostic tool in the modern sense. It doesn't incorporate AI assistance for diagnostic improvement.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable/No. The Centricity™ PACS System is explicitly designed as a "human-in-the-loop" system, intended to be used by "trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses," for diagnosis, review, and analysis. It is described as a tool for these professionals, not a standalone diagnostic algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not specified. As no direct performance study with diagnostic accuracy as an endpoint is described, the type of ground truth used for such a study is not mentioned. The device's "effectiveness" is linked to its functional capabilities and equivalence to predicate devices, not to its diagnostic accuracy against a defined ground truth.

7. The sample size for the training set:

   • Not applicable/Not specified. The Centricity™ PACS System as described is an image management and viewing system, not a machine learning or AI algorithm that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable/Not specified. As the system is not described as involving machine learning, there is no concept of a training set or its associated ground truth establishment.

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