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510(k) Data Aggregation
(97 days)
The syngo X Workplace is a medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage of medical images and data on exchange media. It is used for diagnostic image viewing and post processing and for viewing and post processing during interventional procedures.
The syngo X Workplace can be configured as stand-alone diagnostic review, post-processing, and reporting workstation. It can also be configured within a network to send and receive DICOM data. Furthermore, the X Workplace can be combined with systems of the Artis family. In combination with an Artis system, it provides image guided solutions in the operating room, for image guided surgery, by Image Fusion and by navigation systems, image guided solutions in interventional cardiology and electrophysiology and image guided solutions for interventional oncology, interventional radiology, and interventional neuroradiology.
The syngo X Workplace can also be combined with fluoroscopy systems or Radiographic systems.
The syngo X Workplace can be configured with a variety of syngo or Windowsbased software options, which are intended to assist the physician in diagnosis, treatment planning and treatment control. It includes commercially available postprocessing techniques and OEM options.
Procedures that can be performed include: minimally invasive surgical procedures and minimally invasive tumor treatment.
The syngo X Workplace (XWP). SW Version VD10 is a medical diagnostic workstation for real-time viewing, image manipulation, communication, and storage of medical images and data on exchange media. It is a further development of the X-LEONARDO Workstation and offers a comprehensive solution to view, optimize, and postprocess diagnostic information and to aid the doctors in the evaluation of digital radiological examinations and patient information. It can be configured with different combinations of clinical applications based on modality image type and clinical focus.
The provided document is a 510(k) summary for the syngo X-Workplace SW VD10, seeking clearance based on substantial equivalence to the predicate device, the X-LEONARDO Workstation (K042995). The document describes the device, its intended use, and comparisons to the predicate, along with non-clinical performance testing.
Here's a breakdown of the requested information based on the document:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly list specific numerical acceptance criteria. Instead, it makes general statements about testing and conformance.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|
| Conformity with performance standards: IEC 60950-1+A1, 94 A/B, 60601-1-2, 14971, 60601-1-6, 62304, 60038, CAN 7CSA-C22.2 No. 60950-1-08, NEMA PS3 and following / ISO 12052. | Siemens claims conformance to all listed standards. |
| All software specifications meeting acceptance criteria. | "The testing results supports that all the software specifications have met the acceptance criteria." |
| Acceptable verification and validation for supporting claims of substantial equivalence. | "Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence." |
| Performance tests for functionality yielding acceptable results. | "Results of all conducted testing and clinical images were found acceptable in supporting the claim of substantial equivalence." |
| Cybersecurity requirements met (preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information). | Siemens conforms to cybersecurity requirements by implementing a process to prevent unauthorized access, modifications, misuse, or denial of use, or the unauthorized use of information. Cybersecurity statement considers IEC 80001-1:2010. |
| Risk management ensuring hazards are controlled. | Risk management (hazard analysis, software development, verification/validation testing) is used to control potential hazards. |
| Instructions for use enabling safe and effective operation. | "Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner." |
2. Sample size used for the test set and the data provenance
The document states "clinical images" were used for testing, but does not specify the sample size of these images or their provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states "clinical images" were provided and used in testing, but does not specify the number of experts used to establish ground truth or their qualifications. It only mentions that "operators are health care professionals familiar with and responsible for the evaluating and post processing of medical images." This statement refers to the intended users of the device, not necessarily experts establishing ground truth for testing.
4. Adjudication method for the test set
The document does not describe any adjudication method used for establishing ground truth for the test set.
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 mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size related to human readers improving with or without AI assistance. The device is a medical workstation, not explicitly an AI-assisted diagnostic tool in the sense of providing automated interpretations to readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as a "medical workstation for real-time viewing, image manipulation, 3D-visualization, communication, and storage" and "intended to assist the physician in diagnosis, treatment planning and treatment control." This strongly implies a human-in-the-loop performance model rather than a standalone algorithm. The document does not explicitly state that a standalone (algorithm-only) performance evaluation was conducted.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document refers to the use of "clinical images" for testing but does not specify the type of ground truth used for these images.
8. The sample size for the training set
The document does not provide information on the sample size used for a training set. The submission focuses on verification and validation of software modifications to an existing predicate device, not the development of a new algorithm requiring a distinct training phase.
9. How the ground truth for the training set was established
Since no training set information is provided, how ground truth for a training set was established is not mentioned.
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