NAEOTOM Alpha

Bench

sample size not stated

endpoints: The bench test evaluates and compares the accuracy of the three sub-features FAST Isocentering, FAST Range, and FAST Direction to the accuracy of the predicate device with syngo CT VA50 using the old camera hardware and the then only available ceiling mount.; The objectives of the bench test are to demonstrate that the FAST 3D Camera feature of the subject device with SOMARIS/10 syngo CT VB10, where the algorithms have been optimized for a new camera hardware in two mounting positions, achieves comparable results as the predicate device with syngo CT VA50.; The FAST Isocentering accuracy of the subject device with syngo CT VB10 is comparable to the predicate device with syngo CT VA50, regardless of the camera mounting position.; For the FAST Range feature, the detection accuracy of all body region boundaries is comparable between the subject device with syngo CT VB10 and predicate device with syngo CT VA50.; The FAST Direction pose detection results are of comparable accuracy for subject and predicate device, regardless of the camera mounting position.; Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to the SOMARIS/10 syngo CT VA50 predicate for the new FAST 3D Camera hardware.

Bench

sample size not stated

endpoints: This document describes a hardware test in which a CT system with extended distance between CT gantry and patient table base plus a mobile C-arm system were combined to evaluate the technical feasibility and possible limitations of this combination.; The range of possible movement for the mobile C-arm in different positions between CT gantry and patient table was tested and documented by measurement of angles.; Based on the test results it can be concluded that a CT scanner, equipped with a Multi-Purpose (Vitus) Patient Table, which is installed with enhanced distance (674 mm) to the CT gantry and offers the iCT mode functionality, provides sufficient freedom of movement for a mobile C-arm X-ray system to be used for clinical routine without any significant limitations for my needle Laser or 3D Camera.

Bench

sample size not stated

endpoints: that the number of artefacts which can be attributed to a stack misalignment (e.g. discontinuities in vessel structures, anatomical steps at air-soft-tissue interfaces, doubling of vessel or other anatomy) and which are often caused by incomplete patient breath-hold can be reduced in a "Cardiac Stack Artefact Correction" (SAC) reconstruction compared to the standard reconstruction with otherwise matching reconstruction parameters.; that no artefacts are introduced by a SAC reconstruction.; If misalignment artefacts are identified in non-corrected standard ECG-gated reconstructed sequence or spiral images, the feature "Cardiac Stack Artefact Correction" (SAC, marketing name: ZeeFree) enables optional stack artefact corrected images, which reduce the number of alignment artefacts.; The SAC reconstruction does not introduce new artefacts, which were previously not present in the non-corrected standard reconstruction.; The SAC reconstruction does realize equivalent image quality in quantitative standard physics phantom-based measurements (ACR, Gammex phantom) in terms of noise, homogeneity, high-contrast resolution, slice thickness and CNR compared to a non-corrected standard reconstruction.; The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction.; The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device.; The SAC algorithm is independent from the physical detector width of the acquired data

Bench

sample size not stated

endpoints: Tests were performed to ensure clinical usability of the myNeedle Guide needle detection algorithm. Two individual tests were performed. The accuracy of the automatic needle detection algorithm was tested. The reduction of necessary user interactions for navigating to a needle-oriented view with and without the support of the automatic needle detection algorithm was analyzed.; It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases.; Further, the results of this bench test clearly shows that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW. Zero user interactions are required and a needle-aligned view is displayed right away after a new scan, if auto needle detection is switched on in the SW

Bench

sample size not stated

endpoints: T3D reconstructions in Quantumpeak mode are possible with the sharpest available kernels up to Qr89, Br98, etc.; Quantumpeak scan mode allows reconstructions of monoenergetic images at energy levels from 40 to 190 keV.; with T3D reconstructions from Quantumpeak scan modes, high resolution images with sharp kernel up to Br98 are obtained. The resolution is comparable to other Highresultra scan modes of the NAEOTOM Alpha.; Monoenergetic reconstructions from Quantumpeak scan modes are free of artifacts. Measured CT values precisely match the reference values.; The accuracy of monoenergetic reconstructions in iodine and calcium inserts at the NAEOTOM Alpha is comparable or better than on the secondary predicate device SOMATOM Force.

Bench

sample size not stated

endpoints: Quantitative assessment in terms of image noise and a visual assessment of the image quality in ECG gated acquisitions between different scan modes is performed: standard acquisition mode with spectral and non-spectral reconstruction, ultra-high resolution acquisition mode with non-spectral reconstruction (120x0.2 mm and 96x0.2 mm) and spectral image reconstruction (limited to 96x0.2 mm).; Based on the results it can be concluded that substantial equivalence in image quality is achieved by the images derived from the spectral capable cardiac acquisition mode 96x0.2mm for both, the high-resolution UHR and the standard resolution spectral image cases, compared to the single source spectral capable 120x0.2mm UHR scan mode.

Bench

sample size not stated

endpoints: Tests were performed to evaluate the performance of HD FoV on NAEOTOM Alpha.; For this purpose, the HU accuracy in the extended field of view region was measured based on phantom studies. The phantom diameter accuracy has been also evaluated.; Based on the results it can be concluded that HD FoV enables the reconstruction of images while significantly improving the visualization of anatomy in the regions outside the scan field of view of 50 cm. In the phantom study, an HU value accuracy of about ± 40 HU was achieved with skin-line accuracy of about ± 3 mm.