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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.

For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used. Also only monitors which received FDA clearance for mammography must be used. syngo® Imaging also supports storage and archiving of DICOM Structured 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 V31.

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.

For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used.

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, especially by supporting the role based and context sensitive RIS portals (such as "Portal Radiologist").

Enhanced syngo® Imaging workplaces use a variety of advanced post processing 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 V31 contains 2 improvements on front end for usability, such as query enhancements and calibration improvements.

The provided 510(k) summary for Siemens' syngo® Imaging (version V31) is a software-only system described as a Picture Archiving and Communication System (PACS). It is intended to display, process, read, report, communicate, distribute, store, and archive digital radiological images, including digital mammography images. It supports physicians in diagnosis and treatment planning.

Crucially, this 510(k) submission does not contain a study presenting specific acceptance criteria or device performance data in the format of a clinical trial or performance study. Instead, it is a Special 510(k), indicating a modification to an already cleared device. The primary method for proving safety and effectiveness in such cases is demonstrating substantial equivalence to previously cleared predicate devices, by showing that the new device does not introduce new potential safety risks and performs as well as the predicates.

Therefore, many of the requested elements for a study proving acceptance criteria will not be present in this document.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

As this is a Special 510(k) focused on substantial equivalence to predicate devices for a PACS system, there are no specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy) or performance metrics for a diagnostic task reported in the document. The acceptance for a PACS system is generally tied to its ability to reliably perform its stated functions (display, process, store, etc.) and integrate with existing systems, rather than diagnostic accuracy metrics.

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

No specific test set or data provenance is mentioned as there isn't a performance study evaluating diagnostic accuracy. The "test set" for a PACS system mainly involves verification and validation testing to ensure software functionality, interoperability, and adherence to DICOM standards. These tests are typically conducted internally by the manufacturer and are not detailed in the 510(k) summary concerning specific image datasets or patient cohorts.

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

Not applicable. As there is no diagnostic performance study, there's no "ground truth" to establish for a test set in the context of expert review of images for disease detection.

4. Adjudication Method for the Test Set:

Not applicable for the reasons stated above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. This type of study is typically performed for AI or CAD devices that directly aid in diagnostic interpretation, not for a general PACS system like syngo® Imaging.

6. If a Standalone Study Was Done:

No, a standalone (algorithm only without human-in-the-loop performance) study was not done for diagnostic accuracy. The device itself is a PACS, which is inherently a human-in-the-loop system designed to present images for human interpretation.

7. The Type of Ground Truth Used:

Not applicable. For a PACS system, "ground truth" relates to the correct functioning of the software, adherence to standards, and successful image archiving/retrieval, not to a diagnostic outcome or pathology finding from a specific image dataset.

8. The Sample Size for the Training Set:

Not applicable. This device is a PACS, not an AI or CAD system that would typically undergo a training phase on a large dataset of medical images.

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

Not applicable, as there is no training set for a machine learning model.

In summary, the 510(k) K081734 for syngo® Imaging (version V31) is a Special 510(k) demonstrating substantial equivalence to previously cleared PACS devices. It focuses on proving that the enhanced version maintains safety and effectiveness and performs comparably to its predicates, particularly highlighting compliance with conditions for digital mammography image handling and general PACS functionalities. It does not present a clinical performance study with specific diagnostic acceptance criteria, test sets, or ground truth establishment because it's a PACS, not a diagnostic AI/CAD system.

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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.

For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used. Also only monitors which received FDA approval for mammography must be used. syngo® Imaging also supports storage and archiving of DICOM Structured 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 V30.

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

It supports the physician in diagnosis and treatment planning.

For primary image diagnosis in mammography only uncompressed or non-lossy compressed images and only pre-processed DICOM "For Presentation" images must be used. Also only monitors which received FDA approval for mammography must be used,

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. especially by supporting the role based and context sensitive RIS portals (such as "Portal Radiologist"). Enhanced syngo® Imaging workplaces use a variety of advanced post processing 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 V30 contains multiple improvements and optimizations on front end for usability, such as layout enhancements and display improvements.

The three syngo® Imaging workplace deployments ...

• syngo® Web Studio a web-based viewing application mainly used for image distribution a)
• b) syngo® Basic Studio - for basic reporting, inside as well as outside of the radiology (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 post processing, reporting, viewing and communicating / distributing of radiological softcopy images (including digital mammographic images) and so allow 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).

The syngo Imaging supports external post processing via the OEM interface by integration of the 314 party application syngo® WebSpace (K062673).

By usage of only specific FDA approved monitors (e.g Siemens AG: SMVD 21500 or Dj(S)}-2103-D-5MP - K043122) validated together with the software, diagnosis on digital mammography images is possible, if images are not compressed lossy, as disclaimed respectively.

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 DIC ()M-Archive (LTS Long-term Storage) in accordance with the DIC()M Conformance Statement.

The Workflow Management enables by integration of any HL7- / DICOM-compatible RIS (IHE Year 5) to the syngo® Imaging PACS a consistent workflow – from patient revisuration to requirement scheduling to a personal work list and supports therefore reporting, documentation or administrative tasks.

syngo® Imaging (version V30) 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 LINUX and Windows 2003 operating system. The workplaces are based on Windows XP. Any hardware platform, which is Windows / Windows XP certified, will be supported.

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

By usage of redundant hardware component and cluster software a high availability concept could be realized, which provides as less as possible system downtime.

This 510(k) submission for the syngo® Imaging (version V30) PACS system does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a specific study proving device performance.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given text. PACS systems generally have performance criteria related to image display accuracy, speed, information integrity, and workflow efficiency. However, no specific metrics or targets are mentioned.

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

This information is not provided. The submission states that "Risk management is ensured via a risk analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing," but no specifics on the test set for these activities are given.

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

This information is not provided.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Improvement with AI vs. Without AI Assistance

This information is not provided. The device is a Picture Archiving and Communication System (PACS), which is infrastructure software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or aiding human readers in specific diagnostic tasks which would typically be evaluated with MRMC studies in this context. While it mentions "advanced post processing applications," it doesn't describe them as AI tools for diagnostic improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not provided. As a PACS system, its primary function is to display, store, and manage images for human interpretation, not to provide standalone diagnostic results.

7. The Type of Ground Truth Used

This information is not provided.

8. The Sample Size for the Training Set

This information is not provided.

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

This information is not provided.

Summary of Device and Evidence from the Submission:

The document describes syngo® Imaging (version V30) as 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 physicians in diagnosis and treatment planning.

Key features highlighted related to performance and safety include:

• Mammography support: Requires uncompressed or non-lossy compressed images, pre-processed DICOM "For Presentation" images, and FDA-approved monitors for primary image diagnosis.
• "Hardware independent" solution: Can be distributed as software only or combined with common IT hardware that meets predefined minimum requirements.
• Risk Management: States that risk management is ensured via a risk analysis to identify potential hazards, controlled through software development, verification, and validation testing. Adherence to recognized industry practice and standards to minimize electrical, mechanical, and radiation hazards.
• Substantial Equivalence: The primary "proof" of safety and effectiveness for this type of device in a 510(k) submission is typically its substantial equivalence to legally marketed predicate devices. The submission claims substantial equivalence to:
  • Siemens syngo Imaging (K05240i)
  • Siemens syngo MultiModality Workplace (K061964)
    The claim is that syngo® Imaging (V30) has the same intended use and similar technical characteristics, and "does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate devices."

In conclusion, this 510(k) summary focuses on the device's intended use, technological characteristics, and its substantial equivalence to previously cleared devices. It does not contain a specific performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert evaluations that would be typical for an AI-powered diagnostic device or a device making quantitative performance claims. The "study" here is implicitly the substantiation of technical similarity and risk mitigation in comparison to existing predicate devices, rather than a clinical performance study with defined metrics.

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