(85 days)
The LEONARDO is a medical diagnostic workstation for viewing, manipulation, and storage of medical images and data on exchange media. The LEONARDO can be configured as a satellite console, sharing a database with the main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as stand-alone diagnostic review and post-processing workstation. The LEONARDO can be configured with a variety of syngo- or Windows XP-based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques.
This premarket notification covers Siemens LEONARDO syngo-based multimodality workplace. syngo is a universal imaging platform based on Windows XP. Leonardo offers a comprehensive solution to view, optimize, post-process diagnostic information and aid the doctors in the evaluation of digital radiological examinations and patient information. Due to special customer requirements based on the modality image type and the clinical focus, the LEONARDO can be configured with different combinations of syngo-based applications, which can be added to the LEONARDO multimodality workplace individually or as clinical focus packages. The LEONARDO is a medical diagnostic workstation for viewing, manipulation, and storage of medical images and data on exchange media. The LEONARDO can be configured as a satellite console, sharing a database with the main console of a CT, MR, or radiographic/fluoroscopic imaging system, as well as stand-alone diagnostic review and post-processing workstation. The LEONARDO can be configured with a variety of syngo- or Windows XP-based software options, which are intended to assist the physician in diagnosis or treatment planning. This includes commercially available post-processing techniques. The LEONARDO will be marketed as a software only solution for the end-user (with recommended hardware requirements) or as a complete work station for the end-user (hardware and software package). It will be installed by Siemens service engineers. The LEONARDO supports DICOM formatted images and information. The workstation is based on the Windows XP operating system.
This 510(k) submission (K040970) for Siemens LEONARDO, a Picture Archiving and Communications System (PACS), is for a predicate device application. This means the device is being presented as "substantially equivalent" to an already legally marketed device (K010938, also a syngo Multimodality Workstation).
Therefore, this document does not contain specific acceptance criteria or a study demonstrating the device's technical performance against such criteria. Instead, the "proof" of meeting safety and effectiveness is based on its substantial equivalence to the predicate device.
Given this, I cannot provide the requested information in the format because the submission doesn't contain a performance study for the LEONARDO device itself. The key statements are:
- "The LEONARDO Workplace described in this premarket notification has the same intended use and similar technical characteristics as the device listed above."
- "In summary, Siemens is of the opinion that LEONARDO does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device."
To answer some of your points based on this type of submission:
- A table of acceptance criteria and the reported device performance: Not applicable. The submission asserts substantial equivalence rather than reporting performance against specific acceptance criteria for the new device.
- Sample size used for the test set and the data provenance: Not applicable. No new performance testing is detailed for the LEONARDO.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable. This device is a PACS workstation, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable. The device is a workstation, not an algorithm that requires a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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).