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PIUR tUS inside System is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules. PIUR tUS inside System may be used on any adult patient aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply. The PIUR tUS inside System acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging. The PIUR tUS inside System is not intended for body contact (including skin, mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood).

PIUR tUS inside is a medical device which enhances standard ultrasound devices with a three-dimensional (3D) tomographic imaging method for a 3D analysis of ultrasound volumes. With PIUR tUS inside, examining physicians can make diagnostic decisions based on standard 2D as well as 3D image data integrated in an ultrasound device environment. This 3D data provides information which previously could have only been generated using other 3D imaging technologies like CT or MRI. The PIUR tUS inside runs on a compatible GE Healthcare ultrasound system. The PIUR tUS inside takes as an input a sequence of 2D ultrasound images that are transmitted through a software interface from the ultrasound to the PIUR tUS inside. In addition, the PIUR Sensor must be clipped onto the ultrasound transducer using individually designed PIUR Brackets. For image acquisition, the user moves the 2D ultrasound transducer perpendicular to the structure to be imaged over the region of interest of the patient's body. An inertial measurement unit (IMU), which is built into the PIUR Sensor, tracks the orientation of the transducer during the scan and sends this information to the ultrasound via Bluetooth. The PIUR tUS inside combines image information and sensor information to generate tomographic 3D ultrasound volumes on which image analysis can be performed. An important property of this method is the unlimited length of the acquired volume. PIUR tUS inside therefore allows recording and analyzing a complete thyroid lobe. The PIUR tUS inside and the PIUR tUS Infinity Predicate Device share most hardware and software components and algorithms. On the hardware side, both systems use the same PIUR Sensor to track probe movement during a freehand ultrasound acquisition. The data from the PIUR Sensor is transferred wirelessly through a Bluetooth connection to the software where it is being used to generate ultrasound volumes from the freehand sweep. Both systems also share the same volume compounding software algorithms, semi-automatic lobe and nodule segmentation algorithms, and volume calculation algorithms. The performance for image compounding and volume calculations are therefore the same for both systems. The main difference between the PIUR tUS inside System and the Predicate Device is the interface for image retrieval. While the Predicate Device uses the Infinity Box to transfer digital ultrasound images from a third-party ultrasound system to the software through a Wi-Fi connection, the PIUR tUS inside has direct access to the image stream through a software interface. It runs directly on the compatible ultrasound scanners: GE Healthcare LOGIQ E10 (K231966) and GE Healthcare LOGIQ E10s/Fortis (K231989). This, however, is not performance relevant as the image data remains the same. It only reduces the number of compatible ultrasound systems as a close collaboration with the ultrasound manufacturer is required. The PIUR tUS inside System acts as part of the diagnostic chain only and must not be used as a sole source for diagnostic or treatment decisions. The solution is intended to be used on patients aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply, in a non-sterile environment. The solution is not intended to be used on patients with open wounds or irritated skin or during surgery.

PIUR tUS Infinity is a computer-aided detection device intended to assist and support medical professionals in the diagnostic workflow of thyroid and thyroid nodules acquired from FDA-cleared ultrasound systems, including image documentation, analysis, and reporting. The device supports the physician with additional information during image review, including quantification and visualization of sonographic characteristics of thyroid nodules. PIUR tUS Infinity may be used on any adult patient aged 22 and older, independent of gender, linquistic and cultural background, or health status, unless any of the contraindications apply. The PIUR tUS Infinity acts as part of the diagnostic chain and must not be used as a sole source for treatment decisions, but as an add-on solution to regular 2D ultrasound imaging. PIUR tUS Infinity device is not intended for body contact (including skin. mucosal membrane, breached or compromised surfaces, blood path indirect, tissues, bones, dentin, or circulation blood),

PIUR tUS Infinity is a computer-aided solution to aid in the diagnostic workflow of thyroid and thyroid nodules, including image documentation, analysis, and reporting. Computer vision and machine learning algorithms are applied to a sequence of ultrasound images of the thyroid that have been acquired by a compatible FDA-cleared ultrasound system. The solution identifies the thyroid lobe and proposes its margins to the user who then can make adjustments to the segmentation and approve the final result. Based on this, a lobe volume is calculated. With additional user input, thyroid nodules can be marked, quantified, and visualized as multiplanar reconstructions or 3D volume renderings. The system provides a user interface for the user to select the five ACR TI-RADS parameters and calculates the ACR TI-RADS level from the user input for each nodule. All proposed results must be verified, adjusted if necessary, and confirmed by the user before they can be added to an automatically generated clinical report. The Infinity software runs on a stand-alone computer (Infinity Workstation - not part of the medical product) that fulfils the defined minimum requirements. It takes as an input a sequence of ultrasound images that are transmitted from the ultrasound to the Infinity Workstation wirelessly through the Infinity Box. The Infinity Box is a piece of hardware that connects to compatible standard ultrasound systems via digital video output such as HDMI or DVI. It grabs 2D ultrasound images through a video grabber and transfers the images to the Infinity Workstation via Wi-Fi in real-time. In addition, a small Infinity Sensor must be clipped onto the ultrasound transducer using individually designed attachments. An inertial measurement unit (IMU) tracks the orientation of the transducer during the scan and sends this information to the Infinity Workstation via Bluetooth. The Infinity Workstation combines information from the Infinity Box and Sensor to generate tomographic 3D ultrasound volumes on which the abovedescribed image analysis can be performed. The PIUR tUS Infinity acts as part of the diagnostic chain only and must not be used as a sole source for diagnostic or treatment decisions. The solution is intended to be used on patients aged 22 and older, independent of gender, linguistic and cultural background, or health status, unless any of the contraindications apply, in a non-sterile environment. The solution is not intended to be used on patients with open wounds or irritated skin or during surgery.