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The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment.

The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.

In particular, the device is intended to provide:

• Linear distance measurements of anatomical structures,

• Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen.

• Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies,

• Measurement of brightness ratio between structures and in particular between the liver and the kidnev.

• Estimates of speed of sound in the liver.

The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.

E-Scopics' ES Series V2 is an ultraportable ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging and quantitative imaging studies. ES Series V2 consists of a Software App (running on a consumer off-the-shelf Selected Host) and an accessory curved array probe. The system produces images and quantifications, which are displayed on the monitor of the Selected Host. ES Series V2 is operated from the Selected Host multi-touch screen. ES Series V2 also allows the user to perform measurements, to capture images, and to generate printable reports.

ES Series V2 is designed to perform non-invasive measurements of liver/spleen shear wave speed and to estimate tissue stiffness. The e.C5-1 probe is equipped with a mechanical vibrator to produce shear waves in tissue. When used on the spleen applications, shear waves travel through the skin and intercostal space into the abdominal organ. 2D ultrasound is used to track the shear wave and measure its speed. The system then provides an estimate of tissue stiffness. In addition, ES Series V2 is designed to measure several quantitative parameters from B Mode imaging: ultrasound tissue brightness parameters such as ultrasound attenuation and backscattering coefficient, speed of sound, and compute ultrasound brightness ratio between 2 regions in the image. The results of ES Series V2 quantitative imaging modalities are displayed on the selected host monitor.

Here's a breakdown of the acceptance criteria and the study information for the ES Series V2 device, based on the provided text:

Acceptance Criteria and Device Performance

The device's performance was evaluated against precision (within subject coefficient of variation, wCV) and bias (difference from ground truth) on calibrated phantoms. The stated acceptance criteria are reflected in the reported performance.

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