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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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