(9 days)
syngo.x is a software solution intended to be used for viewing, manipulation, and storage of medical images.
It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo.x based software options.
syngo.x supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
This premarket notification covers Siemens enhanced PACS system syngo.x.
syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images. It can be used as a stand-alone device or together with a variety of cleared and unmodified syngo x based software options. syngo x supports interpretation and evaluation of examinations within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments. The system is not intended for the displaying of digital mammography images for diagnosis in the U.S.
The system is a software only medical device. It defines minimum requirements to the hardware it runs on. The hardware itself is not seen as a medical device and not in the scope of this 510(k) submission.
It supports the physician in diagnosis and treatment planning. syngo.x also supports storage of Structured DICOM Reports.
In a comprehensive imaging suite syngo.x integrates Radiology Information Systems (RIS) to enable customer specific workflows.
syngo.x allows to use a variety of advanced applications (clinical applications) designed for syngo.x just as the predicate device syngo MultiModality Workplace (K072728, cleared on April 22, 2007). These applications are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo x medical device. syngo.x has a universal component called generic reader application which is part of this medical device and it allows no newly introduced imaging and postprocessing algorithms compared to the above mentioned predicate devices.
syngo.x is based on Windows. Due to special customer requirements and the clinical focus syngo.x can be configured in the same way as the syngo MultiModality Workplace with different combinations of syngo.x- or Windows -based software options and clinical applications which are intended to assist the physician in diagnosis and/or treatment planning. This includes commercially available post-processing software packages.
syngo.x is a "software only"-system, which will be delivered on CD-ROM / DVD to be installed on common IT hardware. This hardware has to fulfil the · defined requirements. The Software will be installed by Siemens service engineers only.
The herewith described syngo.x supports DICOM formatted images and objects.
The syngo.x will be marketed as a software only solution for the end-user (with recommended hardware requirements). It will be installed by trained service engineers only. Any special needs such as integration in a specific environment and updates / upgrades will be covered by individual service contract and fulfilled by special trained service technicians.
The provided text is a 510(k) summary for the syngo.x Picture Archiving and Communications System (PACS). This document focuses on demonstrating that the syngo.x device is substantially equivalent to previously cleared devices (syngo Imaging and syngo MultiModality Workplace), rather than presenting a study to prove meeting specific acceptance criteria for performance.
Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data details) is not available in this specific 510(k) summary.
The document primarily states that "syngo.x does not introduce any new significant potential safety risks and is substantially equivalent to and performs as well as the predicate devices." This substantial equivalence argument is based on similar intended use and technical characteristics, not on a new clinical study with defined performance metrics.
Here's a breakdown of what can be extracted from the provided text, and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as quantifiable performance metrics for the syngo.x device itself. The acceptance criteria for this 510(k) submission are implicitly demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.
- Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, processing speed targets) are reported for syngo.x. The claim is that it "performs as well as the predicate devices," but no data from a performance study is included to substantiate this in a measurable way.
Missing Information: Specific KPIs, thresholds, and performance results of syngo.x.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not applicable or not specified. There is no mention of a test set being used for a performance study.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable or not specified.
Missing Information: Any details about a performance test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable or not specified.
- Qualifications of Experts: Not applicable or not specified.
Missing Information: Details about experts for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable or not specified.
Missing Information: 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:
- MRMC Comparative Effectiveness Study: No, an MRMC study is not mentioned. The syngo.x is a PACS system for viewing, manipulation, communication, and storage of medical images, and its 510(k) is about demonstrating substantial equivalence to existing PACS systems, not about demonstrating improvement in human reader performance with AI assistance. The document explicitly states that "advanced applications (clinical applications) designed for syngo.x... are medical devices on their own rights and filed separately. They are not part of this 510(k) submission and not part of the syngo x medical device."
Missing Information: MRMC study details and effect size.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No, a standalone algorithm performance study is not mentioned. This device is a PACS system intended for human use and interaction, not a standalone diagnostic algorithm.
Missing Information: Standalone study details.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: Not applicable or not specified. No performance study data is presented.
Missing Information: Type of ground truth.
8. The sample size for the training set:
- Sample Size (Training Set): Not applicable or not specified. No machine learning or AI algorithm development details are provided for syngo.x itself in this submission.
Missing Information: Training set details.
9. How the ground truth for the training set was established:
- Ground Truth Establishment (Training Set): Not applicable or not specified.
Missing Information: Ground truth establishment for training set.
Summary of available information:
The 510(k) summary for syngo.x focuses on:
- Device Description and Intended Use: Viewing, manipulation, communication, and storage of medical images (excluding digital mammography for diagnosis in the U.S.).
- Regulatory Classification: Class II, Product Code LLZ, 21 CFR §892.2050 (Picture Archiving and Communications System).
- Substantial Equivalence: Claimed based on similar intended use and technical characteristics to predicate devices:
- Safety and Effectiveness Concerns: Addressed through risk analysis, software development, verification and validation testing, and adherence to recognized industry practices and standards.
- Software Only: The device is a software-only medical device, with hardware requirements specified, and installation performed by Siemens service engineers.
In essence, this 510(k) submission is a declaration of equivalence to existing PACS systems based on the functionalities and technological aspects of the software, not a report of a new performance study with specific acceptance criteria that the device had to meet through experimental data.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).