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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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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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