(139 days)
The Siemens SOMATOM Definition Flash 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.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
New software version syngo® VA48 (SOMARIS/7 VA48) is a commandbased program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation that will be available on the SOMATOM Definition Flash CT system. syngo® VA48 (SOMARIS/7 VA48) is a further development to the SOMARIS/7 operating software cleared as part of the predicate devices.
syngo® VA48 is scanner platform software that supports the following device features:
1). New system scanner software version SOMARIS/7 VA48 which includes:
-Respiratory - Analysis of Respiratory Rate & Pitch Adjustment -FAST 3D Reconstruction (FAST 3D Align)
-Multiphase reconstruction with extended Field of View
-FAST DE Results (Dual Energy PACS-ready images) -FAST Contact
-Iterative Reconstruction with extended Field of View
-OEM Varian RGSC Online Mode
-Full 4D Lung Scan
-Applications at CT - syngo.via client
- -Temporal MIP (t-MIP)
- -TrueD 4D Viewer
- 2). ADMIRE Iterative Reconstruction (option)
- 3). iMAR Improved Metal Artifact Reduction (option)
- 4). MARIS (Metal Artifact Reduction in Image Space) Option
- 5). HandCARE Quantitative Dose Reduction Option
- 6). CARE Dose4D Dose Reduction Option
There are no modifications to the hardware of the SOMATMOM Definition Flash.
The provided text is a 510(k) premarket notification for the Siemens SOMATOM Definition Flash CT system. It describes the device, its intended use, and its equivalence to previously cleared predicate devices. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study that proves the device meets them.
The document states:
- "The test results show that all of the software specifications have met the acceptance criteria. Verification and validation testing of the device was found acceptable to support the claims of substantial equivalence." (Page 6)
- "Performance tests were conducted to test the functionality of the SOMATOM Definition AS Open configured with software version syngo® VA48. 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. The result of all conducted testing was found acceptable to support the claim of substantial equivalence." (Page 7)
While it confirms that tests were conducted and acceptance criteria were met for software specifications and overall functionality, it does not explicitly list the acceptance criteria themselves, nor does it provide detailed study data, sample sizes, ground truth establishment methods, or specific performance metrics (like sensitivity, specificity, or AUC) that you'd expect from a clinical performance study.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The document focuses on regulatory compliance (510(k) pathway for substantial equivalence) rather than a detailed clinical performance study report.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot provide. The document states that acceptance criteria were met for software specifications and device functionality, but it does not specify what those criteria were (e.g., specific quantitative thresholds for image quality, diagnostic accuracy, or dose reduction) or the numerical 'reported device performance' against them.
2. Sample size(s) used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot provide. The document mentions "non-clinical tests (integration and functional)" and "Performance tests" but does not detail the nature of these tests in terms of patient data (if any), sample sizes, or data provenance. The focus is on software and system functionality testing.
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):
- Cannot provide. The document does not describe any expert-reviewed test sets or ground truth establishment relevant to clinical performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot provide. Not applicable as no expert-reviewed test set is detailed.
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:
- Cannot provide. No mention of MRMC studies or AI assistance for human readers. The device is a CT scanner system with new software features, not an AI-assisted diagnostic tool in the sense of improving human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Cannot provide. While there were "Performance tests" and "software verification and validation," the document doesn't provide details to assess if these were purely standalone performance evaluations of an algorithm in a clinical context (e.g., detecting specific pathologies). The tests appear to be primarily functional and integration tests for a CT system's software update.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot provide. No information on ground truth for clinical performance.
8. The sample size for the training set:
- Cannot provide. The document describes software updates for a CT system, not an AI/machine learning model that would typically have a "training set."
9. How the ground truth for the training set was established:
- Cannot provide. See answer to point 8.
In summary: The provided document is a regulatory submission for a CT system upgrade, demonstrating substantial equivalence through non-clinical and functional testing against recognized standards. It does not contain the detailed clinical performance study information you are seeking.
§ 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.