Search Results

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.

Ask a specific question about this device

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:

• 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.

Ask a specific question about this device

Centricity® Perinatal and Centricity Intensive Care is intended to be used as a data management tool with which a medical institution may define electronic forms to acquire device data and to document, annotate, display, store, print, export and retrieve patient/clinical practice information. This product is a primary tool for documentation as well as an adjunct tool for surveillance.

The Centricity Perinatal and Centricity Intensive Care (CPN-CIC) is a clinical information system used to manage clinical data. The CPN-CIC may be used in the following clinical settings such as:

• Labor and Delivery (Antepartum, Intrapartum)
• Postpartum
• Newborn Nursery
• Critical Care Units (Neonatal Intensive Care, Adult Intensive Care)

The CPN-CIC can be used in the hospitals, physician offices, and outpatient clinics where the system can accept and display data from the following sources such as:

• Physiologic devices
• External hospital and clinical information systems

NOTE: This product does not replace clinical observation and evaluation of the patient at regular intervals by a qualified healthcare provider, who will make diagnoses and decide on treatments and/or interventions. Features of the product are intended to support clinical decision making and should be used in combination with other clinical inputs, such as real time patient observation, physical exam findings and information contained within other systems or recording tools. The product is not intended to be used as a primary monitoring or diagnostic device.

The Centricity® Perinatal and Centricity Intensive Care is a data management tool.

The basis for this submission is a modification to a legally marketed device. Both the proposed device intended use and indications for use statements are equivalent to that of the predicate device and have been reworded to improve clarity.

Since 1999, Data Management Computer Systems and Technology have evolved. GEHC has modified the device by incorporating "state of the art" technology. The most significant changes being listed are: Overall product enhancements for security and privacy (to support HIPAA), interoperability enhancements, clinician notification enhancements, removal of some features only supplied on the old OS/2 platform version, keeping up with technology changes with respect to Windows Operating system, etc. On their own, none of these changes would have triggered a 510k submission. However, it was deemed important to clarify the Intended Use and Indications for use as well as to notify FDA of the current product state since many changes were made to keep up with the evolution of technology.

The provided document is a 510(k) summary for the GE Healthcare Centricity® Perinatal and Centricity Intensive Care system. It describes the device, its intended use, and indications for use, and confirms substantial equivalence to a predicate device.

However, the document does not contain information related to specific acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) studies.

The submission states that the basis for this 510(k) is a modification to a legally marketed device. The changes primarily relate to "Overall product enhancements for security and privacy (to support HIPAA), interoperability enhancements, clinician notification enhancements, removal of some features only supplied on the old OS/2 platform version, keeping up with technology changes with respect to Windows Operating system, etc."

It explicitly states: "On their own, none of these changes would have triggered a 510k submission. However, it was deemed important to clarify the Intended Use and Indications for use as well as to notify FDA of the current product state since many changes were made to keep up with the evolution of technology."

Therefore, this 510(k) is focused on demonstrating substantial equivalence for an updated version of an existing device, primarily due to technological updates and clarity in intended use/indications, rather than presenting a de novo performance study against defined acceptance criteria for a novel functionality.

Based on the provided document, I cannot fulfill the request as it asks for information not present in the given text.

Ask a specific question about this device

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 R4600/CA1000/Digital Hardcopy workstation 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

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 Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy 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 describes a 510(k) premarket notification for the Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy, which are PC-based DICOM workstation platforms for medical image management. However, the submission does not contain information regarding objective acceptance criteria or a specific study designed to prove the device meets such criteria with quantitative performance metrics for AI/CAD functionality.

The document states that "The Centricity Radiology RA600 / Centricity Cardiology CA1000 / Technology: Centricity Digital Hardcopy employs the same functional scientific technology as its predicate devices" and concludes that "GE considers features of the Centricity Radiology RA600 / Centricity Cardiology CA1000 / Centricity Digital Hardcopy are equivalent to those of the predicate devices." This indicates a reliance on substantial equivalence to predicate devices rather than a de novo performance study with specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria and study design for AI performance cannot be extracted from the provided text because they are not present. The submission focuses on the general function and safety of the PACS workstation and its equivalence to previously cleared devices.

Here's a breakdown of what can and cannot be answered based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as quantitative performance metrics for a specific AI/CAD function. The submission focuses on functional equivalence to predicate devices.
• Reported Device Performance: No specific quantitative performance metrics are provided that would typically be associated with AI/CAD device performance (e.g., sensitivity, specificity, AUC). The "Performance testing" mentioned under "Test Summary" likely refers to system-level performance (e.g., speed, reliability, compliance with DICOM standards) rather than clinical diagnostic accuracy of an AI component.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. There is no mention of a test set, sample size, or data provenance for any diagnostic performance evaluation.

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 provided. No test set means no ground truth establishment for a diagnostic performance evaluation.

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

• Not provided. No test set review process described.

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 provided. The submission does not describe an MRMC study or any AI assistance feature for human readers. This device is a PACS workstation, not an AI/CAD diagnostic tool in the sense of providing specific interpretations or improving reader performance on a task.

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

• Not provided. The device described is a workstation for viewing and managing images, not a standalone AI algorithm that provides diagnostic findings independently.

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

• Not applicable / Not provided. As no specific diagnostic performance study for an AI component is described, there's no mention of ground truth types.

8. The sample size for the training set

• Not provided. The device is a software platform, and the submission does not discuss machine learning or AI model training.

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

• Not applicable / Not provided. As no AI training is discussed, ground truth establishment for a training set is not mentioned.

Summary of available information related to validation/testing based on the provided text:

The submission highlights the following quality assurance measures applied to the development, which are standard for software development and system validation, but do not constitute a clinical performance study with defined diagnostic acceptance criteria for an AI component:

• Risk Analysis
• Requirements Reviews
• Design Reviews
• Testing on unit level (Module verification)
• Integration testing (System verification)
• Final acceptance testing (Validation)
• Performance testing
• Safety testing

The core of the submission relies on the concept of substantial equivalence to predicate devices (K042525, K023178, K023100) rather than presenting novel clinical performance data for new AI algorithms. The device functions as a platform for image viewing and management, not as an AI-powered diagnostic aide.

Ask a specific question about this device