Syngo Carbon Clinicals (VA41)

“Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading.”

“The OrthoMatic Spine core algorithm's outputs for six primary spinal measurements—Cobb angles, coronal balance, kyphosis angle, lordosis angle, and sagittal vertical alignment—were assessed against the mean values obtained from the radiologists' assessments. There is no reader study/bench test that was required for the TimeLens tool as the AI algorithm is very simple workflow enhancement algorithm and the above criteria does not affect the algorithm.”

“The dataset was split into 60% for training, 20% for validation, and 20% for model selection. Splitting was done at the patient level, ensuring no overlap between subsets. Stratification ensured balanced representation across data sources and patient positions. There is no reader study/bench test that was required for the TimeLens tool as the AI algorithm is very simple workflow enhancement algorithm and the above criteria does not affect the algorithm.”

“Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Clinicals.”