(34 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 and calculation of uptake ratios between regions of interest.
Scenium 3.0 display and analysis software enables visualization and appropriate rendering of multimodality data, providing a number of features which enable the user to process the acquired image data. Scenium 3.0 is post processing and does not control the scanning features of the system.
The provided text is a 510(k) summary for the Scenium 3.0 device. A 510(k) submission generally establishes substantial equivalence to a predicate device and does not typically involve the presentation of detailed acceptance criteria or extensive clinical studies in the same way a PMA submission might.
Based on the provided document, here's what can be inferred about acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists no specific quantitative acceptance criteria or detailed device performance metrics in a tabular format. The submission focuses on demonstrating substantial equivalence to predicate devices (Scenium 2.0, NeuroTrans3D, Brass) rather than proving performance against predefined clinical thresholds.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify any sample size used for a test set or the provenance of any data used for testing (e.g., country of origin, retrospective or prospective). This type of information would typically be detailed in a separate clinical or performance evaluation report, which is not part of this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set or their qualifications. The submission is based on the functional and technological equivalence of the Scenium 3.0 software to predicate devices for aiding clinicians in assessment and quantification, not on a new clinical claim requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set:
No adjudication method (e.g., 2+1, 3+1, none) is mentioned because the document does not describe a clinical test set that would require such a method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe an MRMC comparative effectiveness study or indicate an effect size for human readers improving with or without AI assistance. This type of study is more common for devices making claims about improving diagnostic accuracy or efficiency with AI. Scenium 3.0 is described as post-processing software that aids in analysis and quantification, implying it's a tool for clinicians rather than an AI-driven diagnostic system in the conventional sense that would undergo MRMC.
6. Standalone (Algorithm Only) Performance Study:
The document does not describe a standalone performance study of the algorithm without human-in-the-loop performance. The device is presented as a tool to "aid the Clinician" and "facilitates comparison," indicating it's designed to be used in conjunction with human interpretation.
7. Type of Ground Truth Used:
The document does not specify the type of ground truth used as it does not detail a study that would necessitate it. The focus is on the software's ability to "enable automated analysis through quantification of mean pixel values located within standard regions of interest" and "facilitate comparison with existing scans," suggesting its functionality is related to data processing and visualization rather than a direct diagnostic output requiring a definitive ground truth.
8. Sample Size for the Training Set:
The document does not provide information on the sample size for a training set. This is because the submission emphasizes the software's functionality and its substantial equivalence to predicate devices, not the development and validation of a new machine learning algorithm that would require a distinct training set.
9. How Ground Truth for the Training Set Was Established:
As no training set is mentioned, there is no information on how its ground truth was established.
Summary of Device and Evidence:
The Scenium 3.0 is a Picture Archiving and Communication System (PACS) and emission computed tomography system software. It's designed to aid clinicians in the assessment and quantification of pathologies from PET and SPECT brain scans by enabling automated analysis through quantification of mean pixel values in regions of interest and facilitating comparison with existing scans.
The study presented in the 510(k) summary is a demonstration of substantial equivalence to legally marketed predicate devices (Scenium 2.0, NeuroTrans3D, Brass). The evidence provided focuses on:
- Indications for Use: The Scenium 3.0's indications are similar to those of the predicate devices, aiding clinicians in assessment and quantification of PET/SPECT brain scans.
- Technological Characteristics: The software is described as similar in uses and applications to the predicate devices, all assisting clinicians with visual evaluation, assessment, and quantification.
- Safety and Effectiveness: The device is stated to be designed and manufactured under Quality System Regulations (21 CFR 820) and complies with relevant standards (21 CFR 892.1200, 21 CFR 892.2050, ISO 14971, ISO 62304).
The acceptance criteria for a 510(k) submission like this are implicit: demonstrating that the new device is as safe and effective as a legally marketed predicate device, and does not raise new questions of safety or effectiveness. The study's "acceptance" is the FDA's clearance, indicating that Siemens Medical Solutions USA, Inc. successfully demonstrated substantial equivalence. Quantitative performance data, clinical study details, and expert adjudication are generally not required for this type of submission unless the new device introduces novel technology or makes new clinical claims that fall outside the scope of predicate devices.
§ 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).