Search Results

syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.

syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network.

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.

syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo Dynamics is a digital image display and reporting system with flexible deployment – it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.

The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound and ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).

syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations.

syngo Dynamics provides various semi-automated anatomical visualization tools.

syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting; A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).

In the United States, monitors (displays) should not be used for diagnosis, unless the monitor (display) has specifically received 510(k) clearance for this purpose.

This FDA 510(k) clearance letter pertains to syngo Dynamics (Version VA41D), a Medical Image Management and Processing System (MIMPS). While the document broadly discusses the device's substantial equivalence to a predicate device (syngo Dynamics VA40F) and its general functionalities, the only specific AI/ML-enabled function for which performance data and acceptance criteria are detailed is the Auto EF algorithm for calculating left ventricular ejection fraction from ultrasound images.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based specifically on the Auto EF algorithm information provided:

1. Table of Acceptance Criteria and Reported Device Performance (Auto EF Algorithm)

The document states that "Additional acceptance criteria were defined with a total of 12 predetermined acceptance criteria," but only explicitly details one primary statistical criterion and provides summarized performance for a few other aspects.

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

• Sample Size for Test Set: n = 150 cases.
• Data Provenance: The test data originated from 3 sites in the U.S., representing geographic diversity from 2 different regions. The data was collected retrospectively, as it was independent of the training data. The document states it is "representative of the intended use population for Auto EF" and balanced for gender, covering ages 21-93 years and BMIs 16.5-48.8. It also included data from three ultrasound manufacturers (Philips, GE, and Siemens).

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

• Number of Experts: 2 experienced sonographers.
• Qualifications: "experienced sonographers." Specific details regarding their years of experience or board certifications are not provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: The two sonographers worked independently to establish the ground truth. There is no mention of a formal adjudication process (e.g., 2+1, 3+1), arbitration by a third expert, or a consensus meeting after independent readings. They "did not have access to Auto EF when establishing the ground truth."

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

• MRMC Study: No. The document explicitly states, "No clinical studies were carried out for syngo Dynamics (Version VA41D). All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." The evaluation focused on the algorithm's performance against ground truth, not on human reader performance with or without AI assistance.
• Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was performed.

6. Standalone (Algorithm-Only) Performance Study

• Standalone Study: Yes. The performance validation of the Auto EF algorithm was conducted in a standalone manner. The "Auto EF results with the subject device" were compared directly against the established ground truth. The algorithm processed the images and generated biplane EF values without human intervention in the calculation process, although the system allows users to "review, edit or reject the results."

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus with a conventional manual method based on the "Method of Disks" (MOD), also known as the Modified Simpson's Rule. The ground truth was established by two independent sonographers calculating left ventricular volumes and ejection fraction.

8. Sample Size for the Training Set

• Training Set Sample Size: Not explicitly stated. The document mentions the algorithm was "re-trained with more training data" compared to the predicate device, but does not provide a specific number.

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

• Training Set Ground Truth Establishment: Not explicitly detailed. The document only states that the "LV auto contouring algorithm has been updated with pre-training and additional annotated training data." It does not specify the method (e.g., expert consensus, manual contouring) or the number/qualifications of experts involved in annotating the training data. However, given that the test set ground truth was established by sonographers using the Method of Disks, it is highly probable that a similar methodology was used for the training data annotation.

Ask a specific question about this device

syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.

syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network.

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.

syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo Dynamics is a digital image display and reporting system with flexible deployment - it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.

The use of syngo Dynamics is focused on cardiac ultrasound (echocardiography), angiography (x-ray), cardiac nuclear medicine (NM), CT and MR studies that cover both adult and pediatric medicine. Also supported is vascular ultrasound in Obstetrics/Gynecology and Maternal Fetal Medicine (fetal echocardiography during pregnancy).

syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations. syngo Dynamics provides various semi-automated anatomical visualization tools.

syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting; A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Device: syngo Dynamics (Version VA40F) - Specifically, the Auto EF algorithm.

Ask a specific question about this device

syngo Dynamics is a multimodality, vendor agnostic Cardiology image and information system intended for medical image management and processing that provides capabilities relating to the review and digital processing of medical images.

syngo Dynamics supports clinicians by providing post image processing functions for image manipulation, and/or quantification that are intended for use in the interpretation and analysis of medical images for disease detection, diagnosis, and/or patient management within the healthcare institution's network.

syngo Dynamics is not intended to be used for display or diagnosis of digital mammography images in the U.S.

syngo Dynamics is a software only medical device which is used with common IT hardware. Recommended configurations are defined for the hardware required to run the device, and hardware is not considered as part of the medical device.

syngo Dynamics is intended to be used by trained healthcare professionals in a professional healthcare facility to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo Dynamics is a digital image display and reporting system with flexible deployment - it can function as a standalone medical device that includes a DICOM Server or as an integrated module within an Electronic Health Record (EHR) System with a DICOM Archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. There are three deployments: Standalone, EHR/EHS Integrated, and Multi-Modality Cardiovascular (MMCV). MMCV deployment functions as a standalone medical device with capability of natively support 2D and 3D CT and MR image types.

syngo Dynamics is based on a client-server architecture. The syngo Dynamics server processes the data from the connected imaging modalities, and stores data and images to a DICOM server and routes them for permanent storage, printing, and review. The client provides the user interface for interactive image viewing, reporting, and processing; and can be installed on network connected workstations.

syngo Dynamics offers multiple access strategies: A Workplace that provides full functionality for reading and reporting: A Remote Workplace that provides additionally compressed images with access to full fidelity images for reading and reporting; and a browser based WebViewer that provides access to additionally compressed images and reports from compatible devices (including mobile devices).

The provided document describes a 510(k) premarket notification for syngo Dynamics (Version VA40E), a medical image management and processing system. The submission aims to demonstrate substantial equivalence to a predicate device, syngo Dynamics VA30 (K171053).

Based on the document, here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for specific performance metrics (e.g., sensitivity, specificity, accuracy) because it is a substantial equivalence submission for a software update rather than a new device that needs to establish clinical efficacy from scratch. The acceptance criteria are implicitly met by demonstrating that the new version performs as well as or better than the predicate device, or that any changes do not introduce new safety or effectiveness concerns.

The performance is primarily evaluated through non-clinical testing (verification and validation) to confirm that the updated software continues to function as intended and maintains the performance of the predicate device, especially considering the added functionalities.

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

• Sample Size: Not explicitly mentioned in terms of number of cases or studies. The submission states that "All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This implies functional testing, integration testing, and performance testing against defined specifications rather than testing with a "test set" of patient data in a clinical trial context.
• Data Provenance: Not applicable, as no clinical studies with patient data were conducted. The testing involved non-clinical verification and validation.

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

• This information is not provided because no clinical studies were conducted, and therefore, no "ground truth" was established by experts for a test set of clinical cases. The device is for image management and processing, and its performance is assessed through technical verification and validation, ensuring it functions correctly and aligns with the predicate device.

4. Adjudication Method for the Test Set

• Not applicable as no clinical test set requiring expert adjudication was used.

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, an MRMC comparative effectiveness study was not done. The device, syngo Dynamics (Version VA40E), is a medical image management and processing system, not an AI-assisted diagnostic tool designed to directly improve human reader performance in interpreting images. It provides functionalities for image manipulation, quantification, review, and reporting.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document implies that standalone software verification and validation were performed for the syngo Dynamics (Version VA40E) software, as it is a "software only medical device." The tests assessed the functionality of the device itself (e.g., image processing algorithms, communication protocols, reporting features) to ensure it meets specifications, which is a form of standalone performance assessment. However, it's not a standalone diagnostic performance study in the sense of a deep learning algorithm detecting disease.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• Again, this is not explicitly stated as no clinical studies establishing diagnostic performance with a ground truth were conducted. For non-clinical software testing, the "ground truth" would likely be the expected output or behavior validated against established functional requirements, design specifications, and relevant industry standards (e.g., DICOM standard conformance for image handling).

8. The Sample Size for the Training Set

• Not applicable. The device is a software system for image management and processing, not a machine learning model that requires a training set of data.

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

• Not applicable, as there is no training set for this type of software.

Ask a specific question about this device

syngo Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting.

As a Cardiology PACS and information system, syngo Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology. Obstetrics and Gynecology or other departments.

syngo Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S.

syngo Dynamics VA30, is a digital image display and reporting system. This system can function as a standalone medical device that includes a DICOM server or as an integrated module within and Electronic Health Record (EHR) System with a DICOM archive that receives images from digital image acquisition devices such as ultrasound and x-ray angiography machines. The syngo Dynamics system provides components that can be used to review, edit and manipulate image data, as well as to generate quantitative data, qualitative date and diagnostic reports. syngo Dynamics VA30 also provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine) and vascular ultrasound studies.

syngo Dynamics is a software only medical device. Recommended configurations are defined for the hardware required to run the device. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.

syngo Dynamics is based on a client-server architecture. The server processes the data from the connected imaging modalities. The client provides the user interface for interactive image viewing and processing and can be installed on remote, network connected, workstation machines or through industry standard virtualization software.

The provided document is a 510(k) summary for the medical device "syngo® Dynamics Version VA30," a Picture Archiving and Communication System (PACS). This document does not describe any quantitative acceptance criteria or a study proving that the device meets such criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (syngo® Dynamics VA10A) based on functional performance, technical characteristics, and adherence to relevant standards.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

• No Diagnostic Performance Claims: The device is a PACS system designed for image management, review, analysis, quantification, and reporting. It is explicitly stated that "syngo Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S." This implies that the device itself is not making diagnostic claims that would require clinical performance metrics like sensitivity or specificity.
• Focus on System Functionality and Safety: The "acceptance criteria" and "study" described are primarily related to software verification and validation, cybersecurity, and risk management, ensuring the system functions as intended and is safe within its defined scope.

However, based on the information provided, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:

Since there are no diagnostic performance metrics (e.g., sensitivity, specificity) for this PACS device, the "acceptance criteria" can be inferred from the non-clinical testing and conformance to standards. The "reported device performance" refers to the successful completion of these tests and compliance.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly mentioned. The document states "All performance testing was conducted in a non-clinical fashion as part of the verification and validation activities for the medical device." This implies internal testing with data relevant to PACS functionalities (e.g., various image formats, sizes, and data types to ensure proper storage, display, and manipulation).
• Data Provenance: Not explicitly mentioned. Given it's a PACS system for various medical images (Ultrasound, XA, DX, DR, PET, Nuclear Medicine), the test data would likely be representative medical images and related patient information used for internal V&V. The data used is almost certainly retrospective as it's for non-clinical V&V, not a prospective clinical study. No country of origin is specified for test data.

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 diagnostic performance study was conducted where "ground truth" for disease states would be required, this information is not relevant or provided. The "truth" for this device's testing would be whether its software functions correctly, adheres to DICOM standards, correctly displays images, and performs specified manipulations/quantifications as per its design specifications.

4. Adjudication method for the test set:

• Not Applicable. Since there was no clinical diagnostic performance study requiring expert interpretation of medical images to establish a ground truth, no adjudication method (like 2+1 or 3+1) was applicable or mentioned.

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 MRMC study was done. The device is a PACS system, not an AI-powered diagnostic algorithm intended to assist human readers in interpretation or alter their diagnostic performance. It is a tool for image and information management. The document explicitly states: "No clinical studies were carried out for syngo Dynamics VA30."

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not Applicable. The device is a PACS system; it doesn't have a "standalone algorithm" in the sense of a diagnostic AI performing automated interpretations. Its performance is intrinsically linked to its functionality as an imaging and information management system, which supports human users. The "software verification and validation" tests its standalone functional capabilities.

7. The type of ground truth used:

• For this device, "ground truth" pertains to the correct functioning of the software according to its specifications and adherence to standards. It would involve comparing the system's output (e.g., displayed image, stored data, reported measurement) against expected, known correct values or behaviors established by engineering specifications, DICOM standards, or manual verification. It's not expert consensus, pathology, or outcomes data as it's not a diagnostic device making clinical claims.

8. The sample size for the training set:

• Not Applicable. This device is a PACS system, not a machine learning or AI algorithm that requires a "training set" of data for model development. Its development follows traditional software engineering principles.

9. How the ground truth for the training set was established:

• Not Applicable. As no training set is used for this type of software, this question is not relevant.

Ask a specific question about this device

syngo® Dynamics is an image and information system intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including review, analysis, quantification and reporting.

As a Cardiology PACS and information system, syngo® Dynamics supports the physician in interpretation and evaluation of examinations within healthcare institutions, in particular, in Cardiology, Obstetrics and Gynecology or other departments.

syngo® Dynamics is not intended to be used for displaying of digital mammography images for diagnosis in the U.S.

The system is a "software only" medical device. It defines recommended requirements to the hardware it runs on. The hardware itself is not considered a medical device and not in the scope of this 510(k) submission.

syngo® Dynamics is a system that includes a DICOM Server which receives, stores, distributes, and archives images from digital image acquisition devices such as ultrasound, computer tomography, magnetic resonance and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows.

syngo® Dynamics Version VA10A provides advanced reporting support for cardiology, OB/GYN, MFM (maternal fetal medicine), vascular ultrasound, including specific echo and cath lab oriented features for documentation support in the cardiology department.

The provided 510(k) summary for syngo® Dynamics (Version VA10A) does not contain detailed information about specific acceptance criteria and a study proving the device meets those criteria in a quantitative sense with performance metrics like sensitivity, specificity, or accuracy.

The document states:
"Siemens conducts testing to verify the design output met the design input requirements and to validate the device conformance to the intended use. Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device."

However, it does not provide the specific acceptance criteria or the reported device performance metrics against those criteria. Instead, the focus of this 510(k) summary is on demonstrating substantial equivalence to a predicate device (syngo® Dynamics Version 9.0 (K102150)) based mainly on functional equivalence, technological characteristics, and risk management.

Here's a breakdown of the information that is available in the provided text, and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The submission focuses on functional equivalence rather than quantitative performance metrics for a specific clinical task.

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

Not explicitly stated for any performance testing. The document mentions "Integration and System Testing were performed for verification and validation of The device," but does not specify the sample size of images, cases, or the origin (country, retrospective/prospective) of any data used for these tests.

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

Not applicable/Not provided. Since no specific clinical performance study with annotated ground truth for a diagnostic task is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable/Not provided. Without a specific clinical performance study and expert-established ground truth, adjudication methods are not discussed.

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

No MRMC comparative effectiveness study is mentioned. The device, a PACS system, is not typically evaluated in this manner, as it's an infrastructure tool rather than a diagnostic algorithm that directly aids human readers in interpretation beyond displaying images. The submission focuses on its capabilities as an image and information system.

6. Standalone (Algorithm Only) Performance Study

No standalone performance study for an algorithm is mentioned. This device is described as a "software only" medical device, but its function is as an image and information system (PACS), not a standalone diagnostic algorithm with a specific output to be evaluated for accuracy.

7. Type of Ground Truth Used

Not applicable/Not provided in relation to a clinical performance study. The ground truth concept for this device's validation would likely revolve around functional correctness, data integrity, and adherence to standards (DICOM, HL7, etc.), rather than clinical diagnostic accuracy against pathology or outcomes data.

8. Sample Size for the Training Set

Not applicable/Not provided. As this is a PACS system and not a machine learning-based diagnostic algorithm, there isn't a "training set" in the sense of data used to train an AI model. Its development would involve software engineering and testing principles.

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

Not applicable/Not provided for the same reasons as #8.

In summary, the 510(k) for syngo® Dynamics (Version VA10A) focuses on establishing substantial equivalence through:

• Identical Intended Use: The device shares the same intended use as its predicate.
• Similar Technological Characteristics: The document provides a detailed table comparing functionalities, operating systems, image sources, display, data handling, and algorithms with the predicate device, highlighting minor enhancements (e.g., collaborative reporting, mobile device support) that do not raise new safety or effectiveness concerns.
• Compliance with Voluntary Standards: DICOM, IEC/ISO, HL7, IEC 62366, SMPTE are listed.
• Risk Management: Adherence to ISO 14971:2007 for risk analysis and control.
• Verification and Validation Testing: General mention of "Integration and System Testing" to verify design output against input and validate conformance to intended use.

The submission confirms that "Predefined acceptance criteria was met" for these tests, but it does not specify what those criteria were in the context of clinical performance metrics, nor does it provide quantitative results from such a study. The nature of a PACS system's 510(k) often centers on functional validation and interoperability rather than diagnostic accuracy as would be required for an AI-powered diagnostic tool.

Ask a specific question about this device

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 addresses the Siemens syngo® Dynamics version 9.0 Picture Archiving and Communication System.

syngo® Dynamics is intended to display, process, read, report, communicate, distribute and store digital medical images. The system is a "software only" medical device. It defines recommended requirements to the hardware it runs on.

The hardware itself is not considered a medical device and not in the scope of this 510(k) submission.

syngo® Dynamics supports the physician in diagnosis and treatment planning. It also supports storage and archiving of DICOM Structured Reports. In a comprehensive imaging suite syngo® Dynamics integrates Hospital / Radiology / Cardiology Information Systems (HIS/RIS/CIS) to enable customer specific workflows.

The syngo® Dynamics new release focuses on support of web based reporting. Also, in syngo® Dynamics 9.0, server as well as the workplaces will be offered as "software-only".

The provided text is a 510(k) summary for the syngo® Dynamics (version 9.0) Picture Archiving and Communication System (PACS). This document primarily describes the device, its intended use, and its substantial equivalence to a predicate device, focusing on regulatory aspects rather than detailed performance studies or elaborate acceptance criteria for specific features beyond general safety and effectiveness.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document states: "Predefined acceptance criteria was met and demonstrated that the device is as safe and effective as the predicate device." However, it does not provide a specific table of acceptance criteria or reported device performance metrics related to diagnostic accuracy, processing speed, or other quantitative performance measures that would typically be found in a detailed validation study. The acceptance criteria appear to be related to demonstrating substantial equivalence to the predicate device and adherence to general safety and effectiveness concerns through risk management, software development, verification, and validation testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not provide information on the sample size used for any test set or the data provenance. The focus is on the software itself and its conformance to standards and risk management.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not provide information on the number of experts, their qualifications, or how ground truth was established for a test set.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

The document does not provide information on any adjudication method.

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

The document does not indicate that an MRMC comparative effectiveness study was conducted. The device is a PACS system for displaying and managing images, not an AI-assisted diagnostic tool in the sense of providing automated interpretations or improving human reader performance in a controlled study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes syngo® Dynamics as a "software only" medical device that supports physicians in diagnosis and treatment planning by displaying, processing, and storing images. It does not perform "standalone" diagnostic tasks in the absence of human interpretation; rather, it provides the tools for human professionals. Thus, a standalone performance study in the context of diagnostic accuracy would not be applicable to this kind of device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The document does not specify the type of ground truth used. Given the nature of the device as a PACS, the ground truth would typically relate to the accuracy of image display, storage, and retrieval, rather than diagnostic accuracy against a clinical reference.

8. The sample size for the training set

The document does not provide information on the sample size for a training set. This is not a machine learning or AI-driven diagnostic device that typically employs training sets.

9. How the ground truth for the training set was established

The document does not provide information on how ground truth for a training set was established, as it does not describe a training set in the context of machine learning.

Ask a specific question about this device

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.

Ask a specific question about this device

syngo® Dynamics is a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulition 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 6.0.

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 and x-ray anglography machines. The system has workplaces that can be used to review, edit, and masinilate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

syngo® Dynamics provides advanced reporting features, including cardiology oriented features for review and analysis of x-ray angiographic images, and the capability to launch 3rd party software applications either as stand alone application or via Internet Explorer,

syngo® Dynamics is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. syngg® Dynamics is installed by Siemens service engineers.

Version 6.0 contains extended features for cardiac cath viewing and reporting as well as for cardiac echo reporting. Further on syngo® Dynamics 6.0 includes enhanced integration of the Siemens Sequoia Ultrasound Product and the Siemens Axiom Sensis product for reporting in the cath lab environment.

syngo® Dynamics, version 6.0 also offers an optional "software only" workplace with full viewing and report generation, which will be delivered on CD-ROM and installed by the end user on his own computer hardware.

Here's an analysis of the provided text regarding the acceptance criteria and study details for the syngo® Dynamics (version 6.0) device.

However, it's important to note that the provided 510(k) summary (K070322) for syngo® Dynamics (version 6.0) does NOT contain information about specific performance acceptance criteria or a study designed to prove the device meets those criteria, as one might find for a diagnostic or AI-driven CAD device. This document is a Class II device clearance for a PACS system, which primarily focuses on image management, storage, and display functionality. The regulatory pathway for such devices often emphasizes substantial equivalence to predicate devices and adherence to general safety and effectiveness concerns rather than specific clinical performance metrics like sensitivity or specificity.

Therefore, many of the requested details, particularly those related to clinical performance studies, ground truth establishment, expert review, and sample sizes for training/test sets, are not present in the provided text.

The information below reflects what can be extracted from the document, with explicit notation where information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

As stated above, this 510(k) summary does not outline specific, quantifiable performance acceptance criteria (e.g., sensitivity, specificity, accuracy) typical of diagnostic or AI-driven devices, nor does it report such performance metrics. The clearance is based on substantial equivalence for a Picture Archiving and Communication System (PACS).

The "acceptance criteria" for this type of device primarily revolve around:

• Functional equivalence to predicate devices: Performing the same functions (acceptance, transfer, display, storage, archive, manipulation of digital medical images, quantification, report generation) as cleared predicate devices.
• Adherence to standards: Compliance with DICOM (Digital Imaging and Communications in Medicine) standards.
• Software validation and verification: Ensuring the software performs as intended without introducing new safety risks.
• Safety assessment: Risk management to identify and control potential hazards.

Therefore, a table of acceptance criteria and reported performance, in the sense of clinical metrics, cannot be directly constructed from this document.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document describes software verification and validation testing, but does not quantify a "test set" in terms of patient cases or images for clinical performance evaluation.
• Data Provenance: Not specified. Given it's a PACS system and the assessment focuses on functional equivalence and safety, the "data" likely refers to simulated or representative medical images and related data used for software testing, rather than a clinical dataset for performance evaluation.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.
  • Explanation: For a PACS system, "ground truth" as typically understood in AI or diagnostic device evaluation (e.g., confirming a diagnosis) is not the primary focus. Development and testing would focus on accurate data handling, display, and workflow, which might involve domain experts (e.g., radiologists, cardiologists) for usability and functional validation, but not typically for establishing diagnostic "ground truth" for an algorithm's performance.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.
  • Explanation: Since a clinical performance test set with diagnostic "ground truth" is not described, an adjudication method for reconciling expert opinions would not be applicable in the context presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• Was an MRMC study done? No, not mentioned in the document.
• Effect size of human readers with/without AI assistance: Not applicable, as no MRMC study or AI assistance is discussed in the context of improving human reader performance.

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

• Was a standalone study done? No. The device is a PACS system, which supports human clinical workflow. While it has components for "quantification," these are tools for human interpretation, not an autonomous diagnostic algorithm.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not specified in the context of clinical performance.
  • Explanation: For a PACS, "ground truth" in testing would generally relate to the correctness of data storage, retrieval, display accuracy (e.g., does the image display correctly?), and functional execution (e.g., does the measurement tool calculate correctly?). This relies on adherence to standards (DICOM) and internal system logic rather than external expert consensus, pathology, or outcomes data for diagnostic accuracy.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. The document does not describe an AI or machine learning component that would require a "training set" in the context of learning to make diagnostic predictions. This is a traditional software system.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no mention of a training set or an AI/ML component.

Ask a specific question about this device

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.

This premarket notification covers Siemens' enhanced system syngo® Dynamics, version 5.0.

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 and x-ray angiography machines. The system has workplaces that can be used to review, edit, and manipulate image data, as well as to generate quantitative data, qualitative data, and diagnostic reports.

synad® Dynamics provides advanced reporting features, including cardiology oriented features for review and analysis of x-ray angiographic images, and the capability to host additional 3rd party software applications.

syngo® Dynamics is a software device that is shipped as a turn key system with pre-installed software on common, off-the-shelf OEM computer hardware. syngo® Dynamics is installed by Siemens service engineers.

Version 5.0 contains extended reporting features to address a broader range of diagnostic imaging needs and other added capabilities for Radiology and Obstetric imaging, while continuing to provide special focus on Cardiology needs including echocardiography, x-ray anqiography, and image storage for nuclear medicine.

synqo® Dynamics, version 5.0 also offers an optional "software only" workplace with full viewing and report generation, which will be delivered on CD-ROM and installed by the end user on his own computer hardware.

Here's an analysis of the provided 510(k) summary for syngo® Dynamics (version 5.0), focusing on acceptance criteria and supporting study details:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for syngo® Dynamics (version 5.0) does not explicitly state specific acceptance criteria or report direct device performance metrics in a quantitative manner.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The core argument for safety and effectiveness is that syngo® Dynamics does not introduce any new potential safety risks and performs as well as the commercially available predicate devices.

Therefore, for this particular submission, the "acceptance criteria" can be implicitly understood as:

• Functional Equivalence: The device performs the same intended functions (acceptance, transfer, display, storage, archive, manipulation of digital medical images, quantification, and report generation) as the predicate devices.
• Safety Equivalence: The device does not introduce new safety risks compared to the predicate devices.
• Compliance with Standards: The device adheres to recognized and established industry practices and standards.

Since no specific performance metrics (e.g., accuracy, speed, uptime) are provided in the summary, a table of reported device performance is not possible to generate from this document.

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

The 510(k) summary does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). The submission relies on establishing substantial equivalence through a comparison of technological characteristics with predicate devices and adherence to risk management processes, rather than reporting on a specific performance study with a test dataset.

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

Since no specific test set or performance study is detailed, there is no information provided regarding the number of experts, their qualifications, or their role in establishing ground truth.

4. Adjudication Method for the Test Set

As no specific test set or performance study is described, there is no information about any adjudication method.

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

The 510(k) summary does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The focus is on substantial equivalence to predicate devices, not on direct comparison of human reader performance with and without AI assistance.

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

The 510(k) summary describes syngo® Dynamics as a "digital image management system," a "software device" that includes features like review, editing, manipulation, quantitative/qualitative data generation, and diagnostic reports. It also mentions an "optional 'software only' workplace with full viewing and report generation."

However, it does not contain information about a standalone (algorithm only) performance study. The device itself is a PACS system designed to be used by humans for managing and interpreting medical images. There's no mention of an embedded AI algorithm whose standalone performance was evaluated independently of human interaction.

7. Type of Ground Truth Used

Given the nature of the submission (substantial equivalence for a PACS system), and the lack of a detailed performance study with a test set, no specific "ground truth" (e.g., expert consensus, pathology, outcomes data) is mentioned as being used for validation. The validation hinges on functional equivalence to predicates and adherence to safety standards.

8. Sample Size for the Training Set

The 510(k) summary does not specify any training set size as it does not describe a machine learning or AI algorithm development that would typically involve a training phase.

9. How Ground Truth for the Training Set was Established

Since no training set is mentioned in the context of an algorithm, there is no information on how ground truth was established for a training set.

Ask a specific question about this device