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Centricity PACS-IW with Universal viewer is a software only product that is part of a Picture Archiving and Communication System (PACS) medical device. Centricity PACS-IW with Universal Viewer is a device that displays medical images (including mammograms) and data from various imaging sources. Images and data can be viewed, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Megapixel resolution and meet other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to radiologists, physicians, nurses, medical technicians, and assistants.

Centricity PACS-IW with Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS-IW with Universal Viewer includes features to access and manage medical imaging studies from Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear medicine (NM). Computerized radiography (CR). Diaital mammography (MG),Digital x-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic x-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic, Microscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN) and other DICOM imaging modalities. Centricity PACS-IW with Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in in most healthcare organizations and utilizes commercially available computer platforms and operating systems. The system does not produce any origing| medical images. All images located on the Centricity PACS, PACS-IW, and Enterprise Archive systems have been received from DICOM compliant modalities and/or image acquisition systems. The Universal Viewer Zero Foot Print (ZFP) clinical viewer is an optional viewer which allows trained professionals to display and manipulate images stored in Centricity Enterprise Archive or other DICOM archive devices. These trained professionals include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants. The Universal Viewer Zero Foot Print option is not intended for primary diagnosis.

Here's a breakdown of the acceptance criteria and study information for the Centricity PACS-IW with Universal Viewer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not contain a specific table of acceptance criteria or quantified device performance metrics. Instead, it states that the device did not require clinical studies. The "acceptance" in this context refers to demonstrating substantial equivalence to a predicate device through non-clinical means.

The "performance" is implicitly deemed acceptable because the device leverages the same fundamental scientific technology as its predicate and the modifications are primarily related to user interface, integration, and minor enhancements, which were validated through non-clinical testing.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not applicable. The document explicitly states: "The subject of this premarket notification submission, Centricity PACS-IW with Universal Viewer, did not require clinical studies to support substantial equivalence."
• Data Provenance: Not applicable, as no clinical studies were performed. The non-clinical testing data provenance is not specified (e.g., country of origin).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable, as no clinical studies were performed and no separate "test set" with expert-established ground truth for performance evaluation is mentioned beyond internal verification and validation.

4. Adjudication Method for the Test Set

Not applicable, as no clinical studies or a separate "test set" requiring adjudication for ground truth were performed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states that clinical studies were not required.

6. Standalone Performance Study

No, a standalone (algorithm only without human-in-the-loop performance) study was not done or at least not described as a separate study for the purpose of demonstrating device performance in this submission. The device is a Picture Archiving and Communication System (PACS) component, intended to be used by human professionals (physicians, radiologists, etc.). Its performance is primarily assessed through its functionality, integration, and display capabilities as part of a human workflow, rather than as a standalone diagnostic algorithm.

7. Type of Ground Truth Used

Not applicable in the context of clinical performance evaluation. For non-clinical verification and validation testing, the "ground truth" would have been defined by the device's functional requirements and design specifications.

8. Sample Size for the Training Set

Not applicable. The Centricity PACS-IW with Universal Viewer is a software product for image DISPLAY and MANAGEMENT, not an AI/ML algorithm that requires a training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this type of software device.

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Centricity PACS-IW by GE Healthcare is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor that offers at least five Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Centricity PACS-IW is an internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).

Centricity PACS-IW includes features to access and manage medical imaging studies and data from computed tomography (CT), magnetic resonance (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammoqraphy (MG), digital x-ray (DX), special procedures and Interventional radiography (XA), PET/CT scan (PT), and other imaging modalities.

Centricity PACS-IW is designed to be deploved over conventional TCP/IP networking infrastructure available in most healthcare organizations utilizing commercially available computer hardware platforms and operating systems. The system does not produce any original medical images. All images located in the Centricity PACS-IW have been received from DICOM compliant modalities and/or systems.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Centricity PACS-IW device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not establish specific quantitative acceptance criteria or provide detailed numerical performance metrics for the Centricity PACS-IW. Instead, it relies on substantial equivalence to a predicate device and verification/validation testing.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket notification submission, Centricity PACS-IW, did not require clinical studies to support substantial equivalence."

Therefore, there is no clinical test set, sample size, or data provenance information provided for an evaluation of the device's diagnostic performance on medical images. The testing focused on software verification and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no clinical test set was used for performance evaluation, no experts were involved in establishing ground truth for such a set.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states that clinical studies were not required. There is no mention of an MRMC study or an effect size for human readers with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The device is a PACS system, designed for human use in interpreting images. Its "performance" is primarily related to its ability to store, communicate, process, and display images reliably, rather than providing automated diagnoses.

7. Type of Ground Truth Used

For the software verification and validation testing, the "ground truth" would have been the expected behavior and outcomes defined by the software requirements and design specifications. For example, for a functional test, the ground truth would be that a specific image should display correctly or that a data transfer should complete without error.

8. Sample Size for the Training Set

Not applicable. This device is a PACS system, not an AI/ML algorithm that requires a "training set" in the conventional sense of machine learning for diagnostic inference. The "training" here refers to software development and testing cycles, not data-driven model training.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of AI/ML for diagnostic inference. The development process likely involved thorough software engineering practices where expected behaviors and outputs were defined by system architects and engineers.

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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:

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.

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Centricity PACS Web DX) PACS System by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicallyd, processed and displayed within the system or across computer networks at distributed locations.

Lossy compressed matther mages and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using and TDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed argepted by FDA.

Typical users of this system are trained professionals, including but not the physicians, radiologists, nurses, medical technicians, and assistants.

Centricity PACS Web Diagnostic (Web DX) PACS System is an Internet bases software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS Web Diagnostic (Web DX) PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentiumbased) and operating systems (Microsoft Windows 2000, Windows 98). The system does not produce any original medical images. All images located on Centricity PACS Web Diagnostic (Web DX) PACS System have been received from DICOM compliant modalities and/or systems.

The provided text is a 510(k) summary for the GE Healthcare Centricity PACS Web Diagnostic (Web DX) PACS System. This document focuses on demonstrating substantial equivalence to predicate devices for a Picture Archiving Communications System (PACS) rather than establishing novel performance claims for a specific algorithm.

Therefore, the document does not contain the detailed information typically found in studies designed to prove a device meets specific performance-based acceptance criteria for an AI or imaging diagnostic algorithm. The information requested in your prompt (acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) is not applicable or available in this type of submission.

Here's a breakdown of why the requested information is not present and what the document does provide:

1. A table of acceptance criteria and the reported device performance: Not applicable. This PACS system is cleared based on functional equivalence to predicate devices, not specific diagnostic performance metrics of an algorithm. Its "performance" is in its ability to accept, transfer, display, store, and process medical images, which was verified through system verification and validation testing, not a comparative clinical study with acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The "testing" referred to is "Thorough system verification and validation testing" to ensure safe and effective use and substantial equivalence, not a clinical test set for an algorithm's diagnostic performance. There is no information on data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. No ground truth for diagnostic performance was established for an algorithm.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 is a PACS system, not an AI-powered diagnostic tool requiring MRMC studies to show improved human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a PACS system, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. There is no AI algorithm being "trained" mentioned in this submission.

9. How the ground truth for the training set was established: Not applicable.

What the document does indicate regarding "testing":

• Substantial Equivalence: The primary "proof" is the demonstration of substantial equivalence to predicate devices (#K072986 IntegradWeb™ PACS System by GE Healthcare Dynamic Imaging Solutions and #K043415 Centricity PACS System by GE Medical Systems). This means its functions are comparable to already legally marketed devices.
• Non-Clinical Testing: "Thorough system verification and validation testing was performed to ensure the safe and effective use of the Centricity PACS Web Diagnostic (Web DX) PACS System." This would typically include software testing, integration testing, cybersecurity, and ensuring compliance with standards for image display, storage, and transfer, rather than diagnostic performance metrics.
• Limitations/Caveats: The document explicitly states limitations, for instance:
  • "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations."
  • "Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." This highlights that the system's role is in data management and display, and appropriate hardware and image types are crucial for diagnostic interpretation by human readers.

In summary, the K053018 submission for the Centricity PACS Web Diagnostic (Web DX) PACS System did not involve a study to prove an algorithm meets specific performance-based acceptance criteria because it is a PACS system, not an AI diagnostic algorithm or a device making primary diagnostic interpretations. Its clearance was based on demonstrating functional equivalence to existing PACS systems and general safety and effectiveness through system-level verification and validation.

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Centricity PACS IW ™ by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Centricity PACS IW ™ PACS System is an Internet bases software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms). Centricity PACS System includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital mammography (DM), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. Centricity PACS IW ™ PACS System is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on Centricity PACS IW ™ PACS System have been received from DICOM compliant modalities and/or systems.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the Centricity PACS IW™ PACS System meets those criteria:

Device Name: Centricity PACS IW™ PACS System

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit, quantitative acceptance criteria with specific performance metrics (e.g., sensitivity, specificity, or objective measurements for image display quality). Instead, the validation appears to be qualitative, focusing on "substantial equivalence" and user experience.

• Acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
• Access and manage studies from various modalities (CT, MR, US, NM, CR, DR, DM, DX, XA, PET).
• Deployment over TCP/IP networks.
• Use of commercial computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, NT, 98). | "Testing performed has shown that the Centricity PACS IW™ PACS System incorporating enhanced PET-CT user preferences is substantially equivalent to the above referenced predicate devices." |
  | II. Safe and Effective Use:
• No contact with the patient.
• Does not control life-sustaining devices.
• Provides ample opportunity for competent human intervention in image interpretation.
• Proper handling of mammographic images (no lossy compression for primary interpretation, requires FDA-approved 5 Mpixel monitor). | "Thorough system verification and validation testing was performed to ensure the safe and effective use of the Centricity PACS IW™ PACS System with enhanced PET-CT user preferences."
  "The information provided... has shown that the Centricity PACS IN™ PACS System with enhanced PET-CT user preferences is substantially equivalent to the predicate device and is safe and effective for its intended use." |
  | III. Enhanced PET-CT User Preferences:
• Improvement or equivalence in user experience with PET-CT specific functionalities compared to the predicate. | "A reader evaluation, consisting of 11 board certified Radiologist was conducted where they evaluated the new enhanced PET-CT user preferences to the predicate device on actual clinical cases." (Implicitly, the evaluation found them equivalent or improved enough for substantial equivalence). |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The text states "actual clinical cases" were used, but the specific number of cases or images in the test set is not provided.
• Data Provenance: The origin of the data (e.g., country) is not specified. It refers to "actual clinical cases," implying retrospective data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: 11 board-certified Radiologists.
• Qualifications: "board certified Radiologist" (no specific number of years of experience mentioned).

4. Adjudication Method for the Test Set

The text describes a "reader evaluation" where 11 radiologists "evaluated the new enhanced PET-CT user preferences to the predicate device." It does not explicitly state an adjudication method (like 2+1 or 3+1 consensus). It implies that their collective evaluation or individual feedback contributed to the substantial equivalence conclusion rather than a formal ground truth adjudication process for specific diagnostic decisions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

• Was it done? Yes, a form of reader comparison was performed. The "reader evaluation, consisting of 11 board certified Radiologist was conducted where they evaluated the new enhanced PET-CT user preferences to the predicate device on actual clinical cases." This compares the experience with the new system's features against a predicate.
• Effect Size of human readers' improvement with AI vs. without AI assistance: This study does not measure improvement with AI assistance. The device is a PACS system, a tool for displaying and managing images, not an AI diagnostic algorithm. The study compared user preferences and the experience of using the PACS features (specifically "enhanced PET-CT user preferences") between the new device and a predicate device. Therefore, there's no "AI vs. without AI assistance" effect size to report here.

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

• Was it done? No, a standalone algorithm performance study was not conducted. The Centricity PACS IW™ PACS System is a Picture Archiving Communications System (PACS), which is a display and management system for medical images, not a diagnostic algorithm that provides standalone interpretations. The system "does not produce any original medical images" and "does not contact the patient, nor does it control any life sustaining devices." Human interpretation is explicitly part of the intended use.

7. The type of ground truth used.

The "ground truth" for this study was based on the evaluation and feedback of 11 board-certified radiologists regarding the "enhanced PET-CT user preferences" on "actual clinical cases." This is more akin to a usability or comparative user experience evaluation rather than a ground truth for diagnostic accuracy (e.g., pathology, clinical outcomes, or expert consensus on disease presence). The study aims to show that the new system's features are at least equivalent in utility and user experience to those of the predicate device.

8. The sample size for the training set.

The document refers to "Thorough system verification and validation testing" and a "reader evaluation." It does not mention a training set in the context of an algorithm. This device is a PACS system, not a machine learning model, so the concept of a "training set" for an algorithm doesn't apply.

9. How the ground truth for the training set was established.

As there is no mention of a training set for an algorithm, the method for establishing its ground truth is not applicable and not provided.

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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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The Centricity PACS Plus system is used to transmit, store and display images throughout a clinical environment. The Centricity PACS Plus is an image display software application that is intended for use by qualified physicians and other personnel for reading, diagnostic review, and analysis of digital images acquired from imaging devices such as CT, MR, CR, DX, MG, US, NM, PET, and other devices. As a part of the PACS Plus system the Centricity RA1000 is used to view digital images that are obtained from a GE Centricity PACS System, or another DICOM device.

See Attachment #2

The provided text is a 510(k) Summary for the Centricity PACS Plus device. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a detailed study with acceptance criteria and performance metrics typically found in clinical trials or validation studies for novel AI/CADe devices.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC effectiveness studies is not available in the provided text.

Based on the available information, here's what can be extracted:

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics. The core "acceptance criterion" for this type of 510(k) is demonstrating substantial equivalence to existing legally marketed predicate devices. The performance is reported as:

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

• Sample size for test set: Not specified.
• Data provenance: Not specified. This document refers to displaying images acquired from various imaging devices (CT, MR, CR, DX, MG, US, NM, PET), but does not detail the origin of data used for any testing.
• Retrospective or prospective: Not specified.

3. 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 the establishment of a ground truth for a test set in the context of device performance evaluation.

4. Adjudication method for the test set:

• Not specified.

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:

• No MRMC study mentioned. This document pertains to a Picture Archiving and Communication System (PACS), which is software for transmitting, storing, and displaying images, not typically a device that directly assists with diagnostic interpretation in the same way a CADe system would, hence an MRMC study for reader improvement with AI assistance is not relevant or described here.

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

• Not applicable/Not mentioned. This device is an image display software application intended for use by qualified personnel, implying human-in-the-loop use. It is not an algorithm that performs standalone diagnostic tasks without human oversight.

7. The type of ground truth used:

• Not specified. This document primarily asserts functionality and comparability for image display and storage, rather than diagnostic accuracy that would require a ground truth for a specific disease or condition.

8. The sample size for the training set:

• Not applicable/Not specified. This document describes a PACS system, which is a software application for image management, not a machine learning or AI algorithm that typically has a "training set" in the conventional sense.

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

• Not applicable/Not specified. As there's no mention of a training set, the establishment of its ground truth is not discussed.

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