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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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