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510(k) Data Aggregation
(100 days)
Centricity Universal Viewer
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed. Typical users of this system are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Contraindications:
Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Centricity Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system that assists radiologists and cardiologists in their diagnostic workflows. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity Universal Viewer provides APIs (Application Program Interfaces) to integrate with third-party medical devices and non-medical devices, which include integration with Tomtec-Arena ™ [1] for advanced cardiology applications.
Centricity Universal Viewer supports DICOM SOP classes to access and manage medical imaging studies from Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear Medicine (NM), Computerized Radiography (CR), Digital mammoaraphy (MG), Digital X-ray (DX), Positron Emission Tomoaraphy (PET/PT), X-Ray Angiography (XA), Digital Intra-oral X-Ray (IO), Radiofluoroscopic X-ray (RF), Secondary Capture Images (SC), Visible Light (VL) Endoscopic and Photographic Image Storage, Slide Coordinates Microscopic Image Storage, Presentation States (PS), Key Image Notes (KIN), and other DICOM imaging modalities.
Centricity Universal Viewer is not intended for the diagnosis of digital pathology images.
Centricity Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.
The system does not produce any original medical images. All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems.
The provided document describes the GE Healthcare Centricity Universal Viewer (K182419), a medical image display and interpretation software. The submission aims to establish substantial equivalence to a predicate device (K150420) by detailing modifications and demonstrating that these changes do not alter the intended use or raise new safety/effectiveness concerns.
Here's an analysis of the acceptance criteria and study information, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative "acceptance criteria" for performance metrics in a pass/fail format. Instead, it focuses on demonstrating "equivalence" to the predicate device and that modifications do not raise new safety or effectiveness issues. The performance is described through verification and validation activities.
| Feature Area | Predicate Device (K150420) Performance | Subject Device (K182419) Performance | Discussion of Differences / Equivalence |
|---|---|---|---|
| Intended Use / Indications For Use | Displays medical images/data, assists in viewing, analysis, diagnostic interpretation, sharing. Mammography interpretation requires compliant monitor. | Identical to predicate device. | No change. |
| Contraindication | Lossy compressed mammographic images and digitized film screen images not for primary interpretation. | Identical to predicate device. | No change. |
| Cath Analysis Tools | Not supported. | Supported: Stenosis Analysis, Left ventricular analysis, Catheter calibration (Point to Point, extension), Distance measurement. | Equivalent. Functionality identical to K063628. No new potential hazards or changes in risk ratings. |
| Workflow: Interactive Search for Studies | Search by: Patient name, ID, Accession Number, Study date, Study description, Modality, Study status, Referring Physician, Date of Birth, Referring Service, Priority, Online status (CPACS only), 0 image studies (CPACS only), Performing physician, Location (EA only for Cardiology). | Same as predicate, except: retrieval of off-line study, access to confidential patient studies based on privileges, increased number of studies the worklist can display (removed 30 study limit), support for Technologist study verification workflow and teaching folder, create/access/save/display key images. | Equivalent. Modifications do not impact device safety and effectiveness. |
| Workflow: Search from DICOM Server | Search for studies on external DICOM server (IW backend only). | Same as predicate, except: search and retrieve prior exams from external DICOM server, save and display DICOM grayscale presentation state object to work with any type of underlying hanging protocol. | Equivalent. Modifications do not impact device safety and effectiveness. |
| Image Display: Ability to Display Information | Ability to display: Image, Report, Patient information, Exam information, DICOM Header, GSPS, RPPS, FCE, Key Image Notes, Exam Notes, Modality and VOI LUT, Structured Reports. | Same as predicate, except: native support of diagnostic interpretation for 2D and DBT mammo images, user/group/system level step protocols, support DICOM metadata in overlay / annotation editor, support synchronized ECG curve/scroll/height selector, support Dorsal view (Reverse ACR IHE) for mammography. | Equivalent. Modifications do not change intended use, device continues to support display/storage/analysis/processing of medical images using similar technology. No new potential hazards or changes in risk ratings. |
| Image Annotations and Measurements | Line, Angle, SUV, OB Measurements, Digital Subtraction Angiography (DSA), Triangulation, MIP/MPR, Spine Labeling, "imager pixel spacing" for CR/DX/US measurements, Cardio Thoracic Ratio (CTR), Image Annotations. | Same as predicate, except: automatically mark images as key when annotated, use "imager pixel spacing" DICOM field for CR/DX/US measurements. | Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information already available to be used in the same way. |
| Customized Hanging Protocols | Smart Reading Protocols, Regular Hanging protocols to launch multiple MIP/MPRs. | Same as predicate, except: multi-modality and multi-vendor hanging protocol, dedicated toolbar for mammography features, smart reading protocols learn user's preferences for MRI multiphasic studies. | Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way. |
| Maximum Intensity Projection (MIP) | MIP with interactive window-level clipping volume of interest, zoom, pan, and rotate. | Same as predicate, except: recalculate standard update value on the fly for PET/CT images, multi-planar reconstruction support multiple oblique reconstruction, support for non-square pixel image calibration. | Equivalent. Modifications do not change intended use. No new potential hazards or changes in risk ratings. |
| Printing: Key Images/Print Pages | Created Print Pages from selected Key Images, one-click placement; customized templates; one click-full screen snapshot. | Identical to predicate device. | No change. |
| Printing: Print to Film / Paper | Print collage of images to printer. | Identical to predicate device. | No change. |
| Connectivity, Interfaces & Interoperability: Integration | Integration COM service. | Identical to predicate device. | No change. |
| Connectivity, Interfaces & Interoperability: Interfaces | Generic interface to integrate outbound with third-party and internal GEHC applications. | Same as predicate, except: update to API connectivity to launch newer versions of 3rd party software applications (e.g., GE Healthcare's EchoPAC and Advantage Workstation). | Equivalent. Modifications do not impact device safety and effectiveness. No new potential hazards. |
| Connectivity, Interfaces & Interoperability: External System Launch | Viewer launched via 3rd party application using: url launch, IVAPI, Inbound API. | Same as predicate, except: updates in interfaces with 3rd party software applications, URL launch using SUID when study associated with multiple orders. | Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way. |
| Administrative: Interactive Query | In console, supporting wildcards. | Identical to predicate device. | No change. |
| Administrative: Setup | Wizard and silent. | Identical to predicate device. | No change. |
| Administrative: On-line Help | Yes. | Identical to predicate device. | No change. |
| Administrative: User Interface and User Manual Languages | 21 languages listed (e.g., English, German, Japanese). | Identical to predicate device. | No change. |
| Administrative: Administrative Rights Assignment | Per user/group. | Identical to predicate device. | No change. |
| Administrative: Automatic Notification Messages | By email, HL7. | Same as predicate, except: auto refresh and notification when new images arrive, merge two studies into one, audit log to track export of images. | Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way. |
| Administrative: System Logging | Combined system log. | Identical to predicate device. | No change. |
| Compression | Wavelet (JPEG2000 lossless/lossy), Non-wavelet (JPEG lossless/lossy), JPEG2000 lossless for uncompressed images. | Identical to predicate device. | No change. |
| Minimal System Requirements: Offering | Turnkey solution (software + hardware), Software only solution. | Identical to predicate device. | No change. |
| Minimal System Requirements: ESXi | VMware vSphere ESXi. | Identical to predicate device. | No change. |
| Workstation Features: Operating System for Diagnostic Workstation | Microsoft™ Windows 7 - 64 bit, Microsoft™ Windows 8.1 - 64 bit. | Same as predicate, except: adding support for Windows 10 operating system (32 or 64 bit) with Internet Explorer 11. | Equivalent. Adding support for Windows 10 does not impact device safety and effectiveness. |
| Workstation Features: Minimum Hardware Requirement for Diagnostic Workstation | 2 Quad-core processor of 2.0 GHz or more, 8GB RAM minimum, 146GB drive in Raid 0, DVD-RW, One 1GB NIC, 4 Mbps and faster TCP-IP network. | Identical to predicate device. | No change. |
| Security: User Authentication using a 3rd Party Authentication Server | Active Directory. | Same as predicate, except: provides common authentication, security hardening and cybersecurity improvements. | Equivalent. Modifications do not impact device safety and effectiveness. |
| Enterprise Imaging: DICOM Protocol | Supports DICOM SOP classes, Receive images - DICOM storage SCP, Support DICOM 3.0 input, presentation states. | Same as predicate, except: support additional color (YBR) interpretations with US images, support saving image calibration information in Presentation State. | Equivalent. Modifications do not impact device safety and effectiveness. Enhancements provide information to be used in the same way. |
| Enterprise Imaging: (XED) Cross Enterprise Display | View patient information across multiple enterprise sites based on matching patient ID numbers. | Same as predicate, except: New API to access patient history in FHIR format and from different sources, enhance ability to group studies anatomically, matching patient studies from remote sites with the same patient. | Equivalent. Modifications do not impact device safety and effectiveness. Enhancements allow patient history to be used in the same way. |
| User Environment | Designed to be utilized inside and outside of radiology and cardiology. | Identical to predicate device. | No change. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (country of origin, retrospective/prospective). It mentions "verification and validation testing" and "system verification testing of system level requirements," but no details on data used in those tests. The only indirect mention of data source for features is that "All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information about the number of experts or their qualifications used to establish ground truth for a test set. This type of information is typically relevant for studies evaluating diagnostic accuracy, which is not the primary focus of this submission (which emphasizes modifications and equivalence of a viewing device).
4. Adjudication Method for the Test Set
No information about an adjudication method is provided, as no specific diagnostic performance study requiring adjudicated ground truth is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size with/without AI Assistance
No MRMC comparative effectiveness study is mentioned. This submission is for a medical image viewing and processing software, not an AI diagnostic algorithm.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No standalone algorithm performance study is mentioned. The device is described as "intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images," indicating human-in-the-loop use.
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used for any testing. Performance is primarily framed around verification against design requirements and validation against user needs and intended uses, implying functional and technical testing rather than diagnostic ground truth.
8. The Sample Size for the Training Set
No information about a training set size is provided. The device is described primarily as viewing and processing software, not a machine learning model that would require a distinct training set. The "Cath Tools" functionality is stated to be identical to a previously cleared product (K063628), suggesting its underlying algorithms may have been established earlier.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how its ground truth would have been established.
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(97 days)
Centricity Universal Viewer
Centricity Universal Viewer is a device that displays medical images and data from various imaging sources, and from other healthcare information sources. Medical images and data can be displayed, communicated, stored, and processed.
Typical users of this system are authorized healthcare professionals.
Centricity Universal Viewer is intended to assist in the viewing, analysis, diagnostic interpretation, and sharing of images and other information.
Mammography images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Contraindications:
Centricity Universal Viewer is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Centricity Universal Viewer is an Internet based medical image display and interpretation software product that is part of a picture archiving and communications system that assists radiologists and cardiologists in their diagnostic workflows. It provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images (including digital mammograms).
Centricity Universal Viewer provides APIs (Application Program Interfaces) to integrate with third-party medical devices and non-medical devices, which include integration with Tomtec-Arena™(K132544) for advanced cardiology applications.
Centricity Universal Viewer supports DICOM SOP classes to access and manage medical imaging studies from , Computed Tomography (CT), Magnetic Resonance (MR), Ultrasound (US), Nuclear Medicine (NM), Computerized Radiography (CR), Digital mammography (MG), Digital X-ray (DX), Positron Emission Tomography (PET/PT), X-Ray Angioaraphy (XA), Diaital 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 Universal Viewer is not intended for the diagnosis of digital pathology images.
Centricity Universal Viewer is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms and operating systems.
The system does not produce any original medical images. All images located on the Centricity Universal Viewer have been received from DICOM compliant modalities and/or image acquisition systems.
The provided text is a 510(k) Summary for the GE Healthcare Centricity Universal Viewer. This document demonstrates substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a clinical study.
Therefore, many of the requested sections about acceptance criteria, study details, ground truth, and expert involvement are not applicable or cannot be extracted from this type of regulatory submission.
However, I can provide information based on what is available in the document:
1. A table of acceptance criteria and the reported device performance
This document does not describe specific numerical acceptance criteria or performance metrics for the Centricity Universal Viewer in the way one would find in a clinical performance study for an AI algorithm. Instead, it focuses on software verification and validation activities to ensure functional equivalence to a predicate device.
| Acceptance Criteria Category | Reported Device Performance (as described in the document) |
|---|---|
| Functional Equivalence | Demonstrated functional equivalence to predicate device (Centricity PACS-IW with Universal Viewer K123174) with specified modifications. |
| Software Quality Assurance | Complies with voluntary standards; applied quality assurance measures including Risk Analysis, Requirements Reviews, Design Reviews, Usability Analysis, Testing (unit, integration, performance, regression, system), and Simulated use testing (Validation). |
| Safety and Effectiveness | Information provided supports the device to be as safe, as effective and substantially equivalent to its predicate device. |
| Compliance | Software documentation provided at a moderate level of concern following FDA guidance. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a clinical performance study with patient data. The testing mentioned (unit, integration, system, simulated use) refers to software engineering verification and validation activities. Therefore, details about sample size, data provenance, or retrospective/prospective nature are not available.
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. The document describes software verification and validation, not a clinical study where ground truth would be established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document describes software verification and validation, not a clinical study requiring ground truth adjudication.
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 comparative effectiveness study is mentioned in this document. The device is a Picture Archiving and Communication System (PACS) viewer, not an AI-assisted diagnostic tool in the sense of providing specific interpretive recommendations. Its purpose is to display and process images for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not an AI algorithm acting in a standalone capacity. It is an image display and processing system intended for human-in-the-loop diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. Ground truth in the context of clinical performance evaluation is not discussed. Software validation focused on ensuring the system performs as designed and intended.
8. The sample size for the training set
Not applicable. This document describes a PACS viewer, not a machine learning or AI algorithm that requires a "training set" of data in the common sense.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" referenced for an AI/ML algorithm within this document.
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(81 days)
CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
Centricity Universal Viewer Zero Footprint client is a device that displays medical images, data from various imaging sources, and other healthcare information sources. Medical images and data can be viewed, communicated, processed and displayed within a computer network or on a workstation. The device may be used to provide images for diagnostic purposes by trained professionals.
Typical users of this system are authorized individuals and trained healthcare professionals who view medical images and data.
Mammographic images may only be interpreted using a monitor compliant with requirements of local regulations and must meet other technical specifications reviewed and accepted by the local regulatory agencies.
Contraindications:
Centricity Universal Viewer Zero Footprint client is contraindicated for the use of lossy compressed mammographic images. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations.
Centricity Universal Viewer Zero Footprint client (ZFP) is a medical software system that is intended for multiple users to remotely access the images stored in a compatible Picture Archiving and Communication System, from compatible computers or workstations on a network, for the purpose of review, diagnostic interpretation and post-diagnostic review of medical images and reports.
ZFP is a viewer that does not produce any original medical images nor does it alter any images or medical data. Specifically, ZFP is an HTML 5 based viewer which runs within a compatible web browser and supports secure transmission of data.
ZFP operates within an operating environment that meets defined minimum specifications (see Section 11.1 for Hardware Description). Both the client and server software of ZFP are only for use with off the shelf hardware technology that meets defined minimum specifications.
ZFP can access data created in multiple systems when stored in Centricity™ Clinical Archive solution and Centricity PACS. Additionally, ZFP can access data from any DICOM compliant archive using Enterprise Archive for query retrieve and data moves.
Authorized users can use the diagnostic quality images for diagnostic purposes. These Authorized users include but are not limited to physicians, radiologists, nurses, medical technicians, and assistants.
The GE Health Centricity Universal Viewer Zero Footprint client is a medical software system intended for displaying medical images and data for diagnostic purposes. The submission is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria for device performance.
Therefore, the provided document explicitly states:
"The subject of this premarket notification submission, Centricity Universal Viewer Zero Footprint client, did not require clinical studies to support substantial equivalence." (Page 4)
This means that a study proving the device meets specific acceptance criteria in the manner requested (e.g., using sample sizes for test sets, expert ground truth, MRMC studies, or standalone performance metrics) was not performed or required for this 510(k) submission. The focus was on non-clinical testing (software documentation, quality assurance measures) and demonstrating that the device is as safe and effective as its predicate.
Given this, I cannot provide the requested information about acceptance criteria and a study proving device performance because the submission explicitly states such a study was not required and therefore not performed.
However, I can extract information related to the device description and its comparison to the predicate device, which forms the basis of its substantial equivalence.
Summary of the Device and its Equivalence:
The Centricity Universal Viewer Zero Footprint client (ZFP) is a medical software system designed for remote access and display of medical images and data stored in compatible Picture Archiving and Communication Systems (PACS). It is an HTML 5 based viewer that runs within a web browser.
1. A table of acceptance criteria and the reported device performance:
As stated above, no specific performance acceptance criteria or reported values from a clinical study are provided in this regulatory submission. The substantial equivalence relies on non-clinical testing and comparison to the predicate device's established performance.
2. Sample size used for the test set and the data provenance:
Not applicable, as no clinical test set was used for this 510(k) submission. Non-clinical testing involved "Verification" and "Validation" testing on unit, integration, regression, system, and simulated use levels, but these do not typically involve a "test set" in the context of clinical performance evaluation.
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 test set with expert-established ground truth was used for this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test set requiring adjudication was used for this 510(k) submission.
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 viewer, not an AI-assisted diagnostic tool. No MRMC study was performed or mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a viewer for human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical performance evaluation. For non-clinical software testing, "ground truth" would relate to expected software behavior based on requirements and design specifications.
8. The sample size for the training set:
Not applicable, as no machine learning algorithm requiring a training set is described for this medical image viewer.
9. How the ground truth for the training set was established:
Not applicable.
Key Information from the Submission Regarding Substantial Equivalence:
- Predicate Device: K123174 - GE Healthcare Centricity PACS-IW with Universal Viewer
- Basis for Equivalence: Comparison of Intended Uses/Indications for Use, technological characteristics, and performance specifications demonstrating functional equivalence to the predicate device.
- Modifications from Predicate:
- ZFP now provides compatibility with Centricity PACS.
- New ZFP enhancements for side-by-side comparison, patient-level inbound URL launch, secure inbound URL token authentication, broader browser support (IE 7 & 8 via Google Chrome Frame, IE 9 & 10, Safari, Firefox), localizable multiple date format, UTF-16 Character Encoding Scheme, and multi-frame cine capabilities (up to 4 in parallel, zoom/pan during cine).
- ZFP may now be accessed from an iPad with internet access (review-only mode; not for primary diagnosis).
- Non-Clinical Tests Conducted: Risk Analysis, Requirements Reviews, Design Reviews, Usability Analysis, Unit testing (Verification), Integration testing (Verification), Regression testing (Verification), System testing (Verification), Simulated use testing (Validation).
- Conclusion of Submission: "Verification and Validation testing results demonstrate that no adverse effects have been introduced by these differences. The Centricity Universal Viewer Zero Footprint client device will continue to have an intended use and functionality fitting within the definition of 21 CFR 892.2050, Picture Archiving and Communication Systems, Product Code LLZ. Information provided in this premarket notification submission supports the Centricity Universal Viewer Zero Footprint client medical device to be as safe, as effective and substantially equivalent to its predicate device."
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