(159 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 SOMATOM Perspective 16 and 32 slice configurations are whole body Xray Computed Tomography Systems. The SOMATOM Perspective 16 and 32 slice configurations produce CT images in DICOM format, which can be used by post-processing applications commercially distributed by Siemens and other vendors.
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, syngo® CT VC28 (SOMARIS/5 VC28) supports several new features which support more economical and energy efficient scanner operation.
The provided text describes a 510(k) submission for the SOMATOM Perspective CT system, which is a medical device. However, it does not include specific acceptance criteria or an explicit study describing the device's performance against such criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence to predicate devices and adherence to relevant safety standards. It mentions "verification and validation testing" and that "all the software specifications have met the acceptance criteria," but it does not detail these criteria or the performance metrics.
Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the given text, nor can I answer questions about sample size for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details, as this information is not present in the provided submission.
The document states:
- Nonclinical Testing: "Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Perspective 16 and 32 slice configurations during product development. The modifications described in this Premarket Notification were supported with verification and validation testing."
- Acceptance Criteria for Software: "The testing results supports that all the software specifications have met the acceptance criteria."
This indicates that testing was performed and acceptance criteria were met, but the specific details of these are not disclosed in this summary.
§ 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.