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Hura CTP™ v1.0 is intended as an image processing software to reduce noise of head CT Perfusion (CTP) DICOM images through multiple algorithm steps.

The software reduces image noise and enhances image contrast (e.g. contrast-to-noise ratio (CNR) and signal-to-noise ratio (SNR)) of the CTP DICOM images. Hura CTP™ v1.0 is non-iterative; hence the low computational overhead enables fast processing and allows no interruption to clinical workflow.

Hura CTP™ v1.0 outputs head CTP DICOM images with enhanced image quality to a designated directory defined by the user. The processed DICOM images can be imported to a third-party post-processing software for quantification of hemodynamic parameters.

The use of this algorithm may enhance the image contrast of head CTP DICOM images depending on the clinical task, patient size, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate imaging protocol to obtain diagnostic image quality for the clinical task.

Hura CTP™ v1.0 is intended for use only by trained and qualified clinical personnel (e.g. radiologists). Hura CTP™ v1.0 is also intended to be used by trained and qualified personnel for installation and maintenance of the software.

Hura CTP™ v1.0 is an image processing software which reduces noise of CTP DICOM images and enhances image contrast and signal-to-noise ratio. Hura CTP™ v1.0 is based on a new algorithm termed k-space weighted image average (KWIA) that was adapted from accelerated 4D dynamic MRI with projection view-sharing. There are two major advantages of KWIA compared to existing denoising method for CTP:

• 1. KWIA is computationally simple and fast (non-iterative); hence the low computation overhead enables fast processing and allows no interruption to clinical workflow.
• 2. KWIA does not make assumptions of noise characteristics and preserves the texture and resolution of CT images.

The software consists of three modules, namely the image input module, the processing module, and the output module. The image input module is responsible for interfacing with DICOM compliant CT scanners and receiving DICOM images. The image processing module is responsible for motion compensation, performing Fourier transform on DICOM images, applying KWIA, and performing inverse Fourier transform to output noise-reduced images. Both original and the noise-reduced DICOM images are then saved to the specified file directory. Hura CTP™ v1.0 is written in C/C++ language and runs as a local application on a standard PC, Mac, or UNIX workstation.

Insight Toolkit (ITK) serves as an important off-the-shelf library that KWIA algorithm leverages for a number of computational operations. The output module is responsible for transmitting noise-reduced CTP DICOM images to a designated directory defined by the user. The DICOM images can be imported to a third-party post-processing software (e.g. iNtuition, RAPID, Vitrea, etc.) for quantification of hemodynamic parameters. The software should be used only by trained professionals including, but not limited to, physicians, medical physicists, and technicians.

The provided text describes the acceptance criteria and a study proving the device meets these criteria. Here is a breakdown of the requested information:

Acceptance Criteria and Device Performance

The provided document does not explicitly state a table of "acceptance criteria" with defined thresholds that the device had to meet (e.g., "SNR increase of at least X%"). Instead, it presents performance metrics observed in the validation studies and refers to "significant reduction" or "significant increase" as evidence of effectiveness. The implicit acceptance criterion appears to be a statistically significant improvement in image quality metrics (SNR, CNR, SD reduction) and preservation of diagnostic information (low NRMSE of TDCs, excellent ICC for perfusion parameters).

Table of Acceptance Criteria and Reported Device Performance

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