(30 days)
The Scenium display and analysis software has been developed to aid the Clinician in the assessment and quantification of pathologies taken from PET and SPECT scans.
The software is deployed via medical imaging workplaces and is organized as a series of workflows which are specific to use with particular drug and disease combinations.
The software aids in the assessment of human brain scans enabling automated analysis through quantification of mean pixel values located within standard regions of interest. It facilitates comparison with existing scans derived from FDG-PET, amyloid-PET, and SPECT studies, calculation of uptake ratios between regions of interest, and subtraction between two functional scans.
Scenium VD20 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process acquired image data.
Scenium VD20 consists of three workflows:
- Database Comparison -
- -Ratio Analysis
- -Subtraction
These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (i.e., Alzheimer's), movement disorders (i.e., Parkinson's) and seizure analysis (i.e., Epilepsy).
The modifications made to the Scenium VD20 software (K150192) to create the Scenium VE10 software include:
- Enabled comparative quantification between Scenium workflows -
- User interface and usability improvements to improve consistency with the syngo.via platform
- Addition of new normal databases to the Database Comparison workflow
- o SPECT HMPAO (Chang AC) normal database
- PET Florbetaben normal database o
- -Stereotactic Surface Projection (SSP) for Amyloid uptake images can now be viewed
These changes are based on current commercially available software features and do not change the technological characteristics of the device.
Scenium VE10 analysis software is intended to be run on commercially available software platforms such as the Siemens syngo.MI Workflow software platform (K150843).
The provided text describes the regulatory clearance for the "Scenium VE10 Software" to be marketed as substantially equivalent to a predicate device. While it mentions "Performance Testing / Safety and Effectiveness" and that "All testing has met the predetermined acceptance values," it does not provide the specific details regarding the acceptance criteria, the study design, or the results that would allow for a comprehensive answer to your request.
Specifically, the document states:
- "Verification and Validation activities have been successfully performed on the software package, including assurance that functions work as designed, performance requirements and specifications have been met, and that all hazard mitigations have been fully implemented. All testing has met the predetermined acceptance values."
This is a general statement about the completion of testing and meeting acceptance values, but it lacks the actual criteria and reported performance.
Therefore, I cannot provide the detailed information you requested, such as:
- A table of acceptance criteria and the reported device performance: The document does not specify these.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth and their qualifications: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned, and the primary purpose of the software is described as aiding clinicians in assessment and quantification, implying it's a tool for human readers, but no MRMC study details are provided.
- If a standalone (algorithm only) performance was done: Not explicitly stated with outcomes. The software performs "automated analysis through quantification of mean pixel values located within standard regions of interest," which implies standalone processing, but performance metrics for this are not given.
- The type of ground truth used: Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document focuses on the regulatory submission process and the determination of substantial equivalence to a predicate device (Scenium VD20 software, K150192) based on minor changes to the software (enabled comparative quantification, UI improvements, addition of new normal databases, and viewing SSP for Amyloid uptake images). It implies that the underlying technology and functionalities for aiding interpretation were already established with the predicate device.
To answer your questions, one would typically need access to the full 510(k) submission, which would contain the detailed studies and performance data. This document is a summary of the FDA's decision, not the full submission itself.
§ 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).