(269 days)
The Siemens SOMATOM Perspective system is intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.
In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images.
For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation.
The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
The Siemens SOMATOM Perspective is a Computed Tomography X- ray System which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.
The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The new version of system software, SOMARIS/5 VC30 supports 1) Localized language support of scan protocols. 2) Easy UI Improvement, 3) iMAR, 4) Study Split Improvement, 5) FAST kV, 6) e-Sleep Improvement, 7) syngo. via client, 8) Touch Panel(FAST Positioning), 9) online help based on knowledge gateway, 10) FAST Wizard, 11) new software field update concept. 12) Temporal-MIP. 13) TrueD-4D viewer, 14) Adaptive Signal Boost Improvement, 15) FAST 3D Align, 16) Dual Spiral Dual Energy, 17) FAST DE Results (for Mono-energetic), 18) Tube Protection, 19) Modified Patient Table.
The provided text describes a 510(k) premarket notification for a Computed Tomography X-ray System, the Siemens SOMATOM Perspective, and its updated software version. However, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets them.
Specifically, the document does not provide:
- A table of acceptance criteria and reported device performance with specific metrics.
- Sample sizes used for a test set, its data provenance, or the number/qualifications of experts for ground truth establishment.
- Adjudication methods.
- Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
- Details of a standalone algorithm performance study.
- Sample size for the training set or how ground truth for the training set was established.
The document focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and adherence to recognized standards.
Here's a summary of the information that is available in the provided text, categorized by your request:
1. A table of acceptance criteria and the reported device performance
- The document states: "Performance tests were conducted to test the functionality of the SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version. These tests have been performed to test the ability of the included features of the subject device. The results of these tests demonstrate that the subject device performs as intended."
- It also mentions: "The testing results supports that all the software specifications have met the acceptance criteria."
- However, specific acceptance criteria (e.g., quantitative metrics for image quality, resolution, noise, dose, or specific diagnostic performance benchmarks) and the corresponding reported values are NOT detailed in this document. The document refers to conformance with various IEC and NEMA standards rather than presenting specific performance data for each criterion.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not specified. The document does not describe a clinical test set or its characteristics. The testing mentioned appears to be primarily non-clinical, focusing on engineering verification and validation against standards.
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)
- Not applicable/Not specified. As no clinical test set for diagnostic performance is detailed, there's no mention of experts establishing ground truth for such a set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. No clinical test set or adjudication method is described.
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
- No, an MRMC study is not mentioned. This document is for a CT scanner and its software updates, not an AI-assisted diagnostic tool in the sense of comparing human reader performance with and without AI. It mentions "iTRIM - Iterative Temporal Resolution Improvement Method" for cardiac imaging, which is a reconstruction algorithm, but its impact is noted as "improves the temporal resolution" rather than a comparative effectiveness study with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies standalone testing of the software's functionality and adherence to standards: "Performance tests were conducted to test the functionality of the SOMATOM Perspective configured with software version SOMARIS/5 VC30 syngo® CT VC30-easylQ version. These tests have been performed to test the ability of the included features of the subject device." However, concrete performance metrics for such standalone tests are not provided beyond the statement that acceptance criteria were met.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not specified for a clinical diagnostic context. The "ground truth" implicitly refers to compliance with established engineering and medical device standards (e.g., IEC, NEMA for safety, performance, and software life cycle).
8. The sample size for the training set
- Not applicable/Not specified. This document does not describe a machine learning model that would require a distinct training set in the typical sense of AI development. It refers to software updates and a reconstruction algorithm (iTRIM), but details on their development or "training" are not provided.
9. How the ground truth for the training set was established
- Not applicable/Not specified. See point 8.
In summary: This 510(k) submission primarily focuses on demonstrating that the updated SOMATOM Perspective CT system and its software (syngo® CT VC30-easyIQ version) are substantially equivalent to previously cleared predicate devices. The "study" referenced is a series of non-clinical verification and validation tests against established medical device standards and internal specifications, confirming that the device performs as intended and meets its software specifications. It does not provide the kind of detailed clinical performance study data (e.g., sensitivity, specificity, reader studies) that would be expected for a diagnostic AI device.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.