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syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.

It supports the physician in diagnosis and treatment planning.

syngo® Imaging also supports storage and archiving of Structured DICOM Reports.

In a comprehensive imaging suite syngo® Imaging integrates Radiology Information Systems (RIS) to enable customer specific workflows.

Enhanced syngo® Imaging workplaces use a variety of advanced postprocessing applications.

This premarket notification covers Siemens enhanced PACS system syngo® Imaging, version V20A.

syngo® Imaging is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital radiological images, including digital mammography images.

It supports the physician in diagnosis and treatment planning.

syngo® Imaging also supports storage and archiving of Structured DICOM Reports.

Enhanced syngo® Imaging workplaces use a variety of advanced postprocessing applications.

The system is a "hardware independent" solution to be distributed either as software only or combined with common IT hardware which must comply to predefined minimum hardware requirements.

The version V20A contains improvements for workplace functionality, such as layout enhancements and display improvements (user interface) and amended functionality.

The three syngo® Imaging workplace deployments ...

• syngo® Web Studio a web-based viewing application mainly used for image distribution a)
• syngo® Basic Studio for basic reporting, inside as well as outside of the radiology b) (standalone workstation)
• syngo® Advanced Studio Advanced Application Bundle for use inside the radiology c) with advanced reporting functionality

... are medical diagnostic and viewing workstations intended for postprocessing, reporting, viewing and communicating / distributing of radiological softcopy images (including digital mammographic images) and so allow radiologists and radiological technicians to receive and process all data needed.

Based on Siemens syngo® software, the syngo® Imaging supports the wide variety of image types and its modular design and is capable of combining applications from different modalities in one workstation.

The syngo® Advanced Studio integrates the modality specific application package syngo® CT Colonography (K042605).

By usage of specific FDA approved monitors (Barco: Coronis dual head 21.3" Medical -K042221; Siemens AG: SMVD 21500 or DjSB-2103-D-5MP - K043122; Planar, Dome C5i-1 and C5i-2 - K032202) diagnosis on digital mammography images is possible, if images are not compressed lossy, as disclaimed respectively.

syngo® Imaging Data Management ensures all authorized personnel fast and continuous access to radiological data. It's main functionality ranges from availability of images having regard to data security, open interfaces, storage media, central system administration, back-up, software distribution to providing a flexible storage hierarchy.

The main purpose is storing and archiving of radiological softcopy images and structured (DICOM) reports.

For PACS server the syngo® Imaging Data Management can be used as a DICOM-Archive (LTS Longterm Storage) in accordance with the DICOM Conformance Statement.

syngo® Imaging (version V20A) is a "software only"-system, which will be delivered on CD-ROM / DVD or as a complete radiology solution consisting of common IT hardware and preinstalled software. syngo® Imaging will be installed by Siemens service engineers.

Defined Hardware requirements are to be met.

The backend communication and storage solution (DM) is based on the Solaris 8 operating system. The workplaces are based on Windows XP, as well as LINUX and IBM operating systems.

The herewith described syngo® Imaging supports DICOM formatted images and objects.

This 510(k) summary for the syngo® Imaging (V20A) PACS system does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, ground truth establishment, sample sizes for training/test sets, MRMC studies, etc.) that would typically be required to prove a device meets specific acceptance criteria in the way you've outlined.

This document is a premarket notification for a Picture Archiving and Communication System (PACS), which is a general imaging software. The FDA 510(k) pathway for such devices often relies on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies with specific performance metrics and acceptance criteria for diagnostic accuracy.

Therefore, I cannot fill out the requested table or answer most of the questions fully as the provided text does not contain this information.

Here's what I can extract and explain based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: The document does not specify quantitative acceptance criteria for image display, processing, or diagnostic accuracy. For a PACS, acceptance criteria would typically focus on functionalities like image loading speed, display quality (resolution, grey-scale accuracy), data integrity, storage capacity, and adherence to DICOM standards. These are generally verified through engineering and functional testing rather than clinical study performance metrics.
• Reported Device Performance: The document states that the device "performs as well as the predicate devices" in terms of its intended use and similar technical characteristics. It notes "improvements for workplace functionality, such as layout enhancements and display improvements (user interface) and amended functionality." However, it doesn't provide specific performance metrics (e.g., image loading times, display luminance, or diagnostic accuracy scores) to quantify these improvements or compare them against predifined acceptance criteria.

2. Sample size used for the test set and the data provenance:
* Not explicitly stated. The document mentions "verification and validation testing" as part of risk management, but it does not specify any test set size or data provenance (e.g., country of origin, retrospective/prospective) for a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/not stated. As there's no diagnostic performance study described, there is no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/not stated. No adjudication method is mentioned as there's no described diagnostic performance study.

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. The document does not describe an MRMC study. This device is a PACS, not an AI-powered diagnostic tool, so such a study would not typically be performed or relevant for its 510(k) submission based on the provided text.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* No. This is a PACS, an infrastructure and viewing system, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
* Not applicable/not stated. No ground truth is discussed as no diagnostic performance study is presented.

8. The sample size for the training set:
* Not applicable/not stated. This is a PACS, not a machine learning model, so there is no concept of a "training set" in the context of its performance validation as described here.

9. How the ground truth for the training set was established:
* Not applicable/not stated. As there is no training set mentioned, there's no information on how its ground truth was established.

Summary of what the document does communicate regarding safety and effectiveness:

• Intended Use: Display, process, read, report, communicate, distribute, store, and archive digital radiological images, including digital mammography images, to support physicians in diagnosis and treatment planning.
• Predicate Devices: Siemens SIENET Cosmos (K042832), LEONARDO (K040970), MammoReport Softcopy Workstation (K042868).
• Substantial Equivalence Argument: Siemens argues that syngo® Imaging (V20A) "has the same intended use and similar technical characteristics" as the predicate devices and "does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices."
• Safety and Effectiveness Concerns: Risk management via risk analysis, software development, verification and validation testing, and adherence to industry practices and standards to minimize electrical, mechanical, and radiation hazards. The device labeling contains instructions for use and warnings.
• Key Features Highlighted: Enhanced workplace functionality, layout and display improvements, amended functionality, support for various image types, modular design, integration of syngo® CT Colonography, data management for storage and archiving, HL7/DICOM compatible RIS integration, and support for specific FDA approved monitors for digital mammography.

Conclusion:

The provided 510(k) summary focuses on demonstrating substantial equivalence of the syngo® Imaging PACS to existing predicate devices based on intended use, technological characteristics, and safety considerations. It does not contain the detailed, quantitative performance study data with specific acceptance criteria, sample sizes, ground truth establishment, or reader studies that would be present for a novel diagnostic algorithm or a device requiring specific performance claims. For a PACS, the "acceptance criteria" are predominantly functional and safety standards, verified through internal engineering and quality assurance processes, rather than clinical efficacy trials.

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