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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.

Study Details

1. Sample size used for the test set and the data provenance:

   • The test set consisted of a "sample of calibrated phantoms." The exact number of phantoms is not specified.
   • The data provenance is in-vitro performance assessment. The document does not specify the country of origin for the phantoms or if the data was retrospective or prospective, as it's an in-vitro study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable for this study. The ground truth for the phantoms was established by their inherent calibrated properties, not by expert consensus.

3. Adjudication method for the test set:

   • Not applicable for this study, as the ground truth was based on calibrated phantoms.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was done. The document explicitly states: "No clinical testing is necessary to demonstrate substantial equivalence between ES Series V2 and its Predicate Device." This study focused on in-vitro technical performance and comparison to a predicate device.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, the performance testing described is a standalone (algorithm only) assessment. The device's quantitative modes (Speed of Sound, Shear Wave Speed/Stiffness, Ultrasound Attenuation, Ultrasound Backscatter Coefficient) were evaluated algorithmically against known ground truth values from calibrated phantoms.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The ground truth used was calibrated phantoms with known reference values.

7. The sample size for the training set:

   • The document does not explicitly state the sample size for the training set. However, given that this is a 510(k) submission primarily focused on demonstrating substantial equivalence to a predicate device through performance testing, the details of the training set used for the underlying algorithms are not typically provided in this summary. The focus is on the performance of the final, developed algorithms.

8. How the ground truth for the training set was established:

   • The document does not explicitly describe how the ground truth for the training set was established. This information is typically proprietary to the developer's internal development process and not required for a 510(k) summary demonstrating equivalence via performance testing.

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