(24 days)
syngo.via MI Workflows are medical diagnostic applications for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR.
syngo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. syngo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. syngo.via MI Workflows can perform harmonization of SUV (PET) across different PET systems or different reconstruction methods.
syngo via MI workflows support the interpretation and evaluations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Nuclear Medicine and Cardiology environments.
Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. syngo.via MI Workflows are a complement to these standard procedures.
The Total Lesion Glycolysis (TLG) feature resides within synqo.via MI Workflows and is a software only medical device which will be delivered on CD-ROM / DVD to be installed onto the commercially available Siemens syngo.via software platform by trained service personnel.
syngo.via MI Workflows is a medical diagnostic application for viewing, manipulation, 3Dvisualization and comparison of medical images from multiple imaqinq modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MIP and volume rendering.
synqo.via MI Workflows enable visualization of information that would otherwise have to be visually compared disjointedly. synqo.via MI Workflows provide analytical tools to help the user assess, and document changes in morphological or functional activity at diagnostic and therapy follow-up examinations. They additionally support the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology (Oncology), Nuclear Medicine and Cardiology environments.
The modifications to the syngo.via MI Workflows (K151192) include the addition of the Total Lesion Glycolysis (TLG) feature within the MM Oncology workflow. This feature will provide the ability for the user to calculate and display the TLG for a given volume of interest (VOI) in addition to calculating and trending the summed Molecular Tumor Volume (MTV) for all VOIs defined for the given PET series.
The provided text is related to a 510(k) premarket notification for a medical device called "syngo.via MI Workflows – Total Lesion Glycolysis (TLG) feature." This document describes the device, its indications for use, and claims substantial equivalence to a previously cleared device (K151192).
However, the document does not contain the detailed information required to describe the acceptance criteria and the specific study that proves the device meets those criteria, as typically found in a clinical study report. The document states that "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 and does not provide specific acceptance criteria or the study details.
Therefore, I cannot fully answer your request based on the provided text. I can, however, extract what little information is present about performance and testing.
Here's an analysis of the provided text, highlighting what can and cannot be answered:
Acceptance Criteria and Study for syngo.via MI Workflows – Total Lesion Glycolysis (TLG) feature
Based on the provided FDA 510(k) summary, specific acceptance criteria and detailed study information are not explicitly stated in a quantifiable manner (e.g., sensitivity, specificity, accuracy thresholds with corresponding confidence intervals). The document primarily focuses on demonstrating substantial equivalence to a predicate device and outlining general software validation processes.
1. Table of Acceptance Criteria and Reported Device Performance
Cannot be fully answered: The document does not provide a table of quantifiable acceptance criteria or reported device performance metrics such as sensitivity, specificity, or accuracy for the TLG feature. It only broadly states: "All testing has met the predetermined acceptance values."
2. Sample Size Used for the Test Set and Data Provenance
Cannot be answered: The document does not specify the sample size used for any test set or the provenance of any data (e.g., country of origin, retrospective or prospective) used for performance evaluation of the TLG feature.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Cannot be answered: The document does not mention the number of experts or their qualifications used to establish ground truth for any testing of the TLG feature.
4. Adjudication Method for the Test Set
Cannot be answered: The document does not describe any adjudication method (e.g., 2+1, 3+1) used for establishing ground truth or evaluating the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Cannot be answered: The document does not indicate that an MRMC comparative effectiveness study was performed. There is no mention of human readers improving with or without AI assistance, nor any effect size.
6. Standalone (Algorithm Only) Performance Study
Partially Answered: The device is described as "software only" and provides "analytical tools to help the user assess, and document changes." This implies that the TLG feature itself performs calculations and provides numerical results. The general statement "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" suggests that the standalone performance of the algorithm for calculating TLG was evaluated to ensure its functionality and accuracy against specified requirements. However, no specific metrics or study details for this standalone performance are provided.
7. Type of Ground Truth Used
Cannot be answered: The document does not specify the type of ground truth used for any testing (e.g., expert consensus, pathology, outcomes data). In the context of a calculation feature like TLG, ground truth would typically refer to a validated reference method for calculating TLG, but this is not detailed.
8. Sample Size for the Training Set
Cannot be answered: The document does not mention a training set or its sample size. This is a software feature update to an existing platform, and typically training sets are more relevant for machine learning algorithms which are not explicitly described as being part of this specific TLG feature's core functionality beyond calculation.
9. How the Ground Truth for the Training Set Was Established
Cannot be answered: Since no training set is mentioned, how its ground truth was established cannot be answered.
Summary of Available Information from the Document:
The 510(k) summary for syngo.via MI Workflows – Total Lesion Glycolysis (TLG) feature focuses on demonstrating substantial equivalence to a predicate device (K151192) and confirming general software validation practices. It explicitly states:
- "The features introduced into syngo.via VB10B had no impact on the technological characteristics already present in the commercially available predicate system."
- "There are no differences in the Indications for Use or Fundamental Technological Characteristics of the synqo.via MI Workflows as compared to the currently commercially available software (K151192)."
- "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 document serves as an FDA clearance declaration based on substantial equivalence, not a detailed technical report of a new device's performance validation study.
§ 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).