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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.

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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Horizon Cardiology™ is an integrated multimodality image and information system designed to perform the necessary functions required for import, export, storage, archival, review, analysis, quantification, reporting and database management of digital cardiovascular images.

Horizon Cardiology™ is intended for use in the Cardiology, Radiology or other departments throughout the healthcare facility and may be part of a larger PACS configuration.

Horizon Cardiology™ offers support for third party plug-ins in order to enable the use of commercially available tools for analysis, quantification and reporting.

Horizon Cardiology™ is an image processing system. The device consists of the following components and accessories: software application; database server; web server; application server; image and document storage server and media; long term archive and disaster recovery media; and client application workstation.

The provided 510(k) summary for McKesson Israel Ltd.'s Horizon Cardiology™ does not contain specific acceptance criteria or a study that evaluates the device against such criteria in terms of clinical performance or accuracy beyond confirming its intended functionality.

Instead, the submission focuses on substantial equivalence to predicate devices based on intended use, technological characteristics, and principles of operation. The "Performance Data" section states that "Verification and validation testing was performed on Horizon Cardiology™ to ensure it met all specifications. The device was further validated to ensure that it performs as intended. In all instances, Horizon Cardiology™ functioned as intended and the results observed demonstrate substantial equivalence with the predicate devices." This suggests internal testing for functionality and specifications, but no detailed clinical performance study with defined acceptance criteria is presented.

Therefore, the requested information cannot be fully extracted from the provided text. However, based on the information given, here's what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of the provided document. The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for a specific diagnostic task). The "performance" discussed broadly refers to the device functioning as intended in comparison to predicate devices, not against specific, measurable clinical outcomes.

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

Not specified. The document mentions "Verification and validation testing" but does not detail the nature of this testing, the size of any test sets (clinical or technical), or the provenance (country of origin, retrospective/prospective) of any data used.

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

Not applicable/Not specified. Since no clinical performance study with a test set and ground truth establishment is described, this information is not present.

4. Adjudication Method for the Test Set

Not applicable/Not specified. As no clinical performance study with a test set is described, there is no mention of an adjudication method.

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

No. The document does not describe a MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated.

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

No. The device is described as an image and information system for import, export, storage, archival, review, analysis, quantification, reporting, and database management. It's a system to support cardiovascular imaging workflows, not a standalone AI algorithm designed for automated diagnostic tasks. Therefore, a standalone performance study in the sense of an "algorithm only" evaluation is not relevant or described.

7. Type of Ground Truth Used

Not applicable/Not specified. Without a clinical performance study, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" for the device's functionality would likely be adherence to technical specifications and successful execution of its stated features.

8. Sample Size for the Training Set

Not applicable/Not specified. As this is not presented as an AI/machine learning diagnostic device in the sense of a predictive algorithm, there is no mention of a training set or its size.

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

Not applicable/Not specified. Similar to the above, without a training set for an AI algorithm, there is no information on how its ground truth would be established.

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syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. syngo® Dynamics is not intended to be used for reading of mammography images.

This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 7.0. syngo® Dynamics is a digital image management system that includes a DICOM server. This system receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound, computer tomography, MRI and xray angiography machines. The system has workplaces that can be irsend to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports. syngo® Dynamics new release focuses on advanced support for cardiology users. Reporting will be enhanced with the option of interactive coronary artery diagrams or the revised cardiac wall motion scoring model. Also, syngo Dynamics 7.0 will add support for CR and DR image types. Version 7.0 contains extended features for existing reporting functionality including hemodynamic data import from selected third party devices, easier serviceability and a flexible operating system support. syngo® Dynamics is a software device that is shipped as a turn key server system with pre-installed server software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers. The workstation with full viewing and report generation functionality is offered "software only" i.e. it will be delivered on CD or DVD media and installed bnothe end user or by a Siemens service engineer on the user's own computer hardward your

This 510(k) summary for syngo® Dynamics (version 7.0) does not contain detailed information regarding acceptance criteria or a specific study proving the device meets those criteria. The document primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's general functionality and safety considerations.

Here's a breakdown of what can be extracted and what is missing:

The document asserts that the device is substantially equivalent to predicate devices, and therefore, it likely meets similar performance standards as those devices. However, explicit performance metrics and an associated study are not provided in this summary.

Information NOT Found in the Document:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document generally states that "syngo® Dynamics 7.0 does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices."
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, how much human readers improve with AI vs without AI assistance: This type of study is not mentioned, and the device is described as a PACS system, not an AI-assisted diagnostic tool in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Information That Can Be Inferred/Extracted (though not directly addressing performance metrics):

• Study Type: The overall "study" presented is a substantial equivalence assessment. The manufacturer asserts that the new version of syngo® Dynamics is substantially equivalent to previously cleared versions (K070322, K053133) and another PACS system (K063628). This implies that the device's performance is, at a minimum, comparable to these predicates for its stated intended use.
• Demonstration of Substantial Equivalence: The document states:
  • "Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development and verification and validation testing." This indicates that verification and validation (V&V) activities were performed, which would typically include testing against acceptance criteria, but the specifics are not disclosed in this summary.
  • "Siemens is of the opinion that syngo® Dynamics 7.0 does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices."

In summary, this 510(k) summary for syngo® Dynamics (version 7.0) is a regulatory document focused on demonstrating substantial equivalence. It does not provide the specific performance data, acceptance criteria, or details of efficacy studies that would be expected for a device making specific diagnostic claims or using AI algorithms for interpretation. The "study" mentioned is the overall V&V and substantial equivalence comparison to predicate devices, rather than a detailed performance study with specific metrics.

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