(93 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 VD10 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 VD10 consists of three main workflows: Database Comparison Workflow, Ratio Analysis Workflow, and Subtraction Workflow. These workflows are used to assist the clinician with the visual evaluation, assessment and quantification of pathologies, such as dementia (ie. Alzheimer's), movement disorders (ie. Parkinson's), and seizure analysis (ie. Epilepsy).
The provided text states that "Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met." However, it does not provide specific acceptance criteria or detailed results of the study that proves the device meets these criteria. It primarily focuses on the device description, indications for use, and a comparison to predicate devices for substantial equivalence.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, and MRMC studies are not available in the given document.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "all performance requirements and specifications were met." |
Explanation: The document generally states that performance and functional testing were conducted and that all requirements were met, but it does not list the specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide quantitative performance metrics for the device against these criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not specified.
- Data provenance: Not specified (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 (e.g. radiologist with 10 years of experience)
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not specified.
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 study: Not mentioned or described. The document focuses on the device's ability to "aid the Clinician," suggesting it's a tool for assistance, but it does not quantify human reader improvement.
- Effect size: Not specified.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not explicitly stated as a separate study with specific metrics. The device is described as "aids the Clinician" and "enabling automated analysis," which implies standalone functionality, but a dedicated standalone performance study with results is not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not specified.
8. The sample size for the training set
- Sample size for training set: Not specified.
9. How the ground truth for the training set was established
- Ground truth for training set: Not specified.
Summary of available information regarding the study:
The document mentions that "Performance and functional testing were conducted for Scenium VD10, and all performance requirements and specifications were met." It also states that "risk management is ensured via a risk analysis in compliance with ISO 14971:2007 and ISO 14971:2012 to identify and provide mitigation to potential hazards."
However, this summary does not contain the detailed study plan, methodology, or results that would typically be present to demonstrate how the device meets specific acceptance criteria in terms of accuracy, sensitivity, specificity, etc., with human-read or pathology-confirmed ground truth. The information provided is high-level and confirms that internal testing was done and deemed successful by the manufacturer, but lacks the granular details requested.
§ 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).