Search Results

The ES1 Ultrasound Diagnostic System 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 beam attenuation and estimates of speed of sound, in internal structures of the body. This device is intended to be used by trained healthcare professionals, in a healthcare environment.

The ES1 Ultrasound Diagnostic System is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.

In particular, the ES1 ultrasound diagnostic system is intended to provide:

• Linear distance measurements of anatomical structures,

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

• Estimates of ultrasound attenuation coefficient in the liver at 3.5 MHz.

• Measurement of brightness ratio between structures and in particular between the liver and the kidney,

• Estimates of speed of sound in the liver.

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

E-Scopics' ES1 System is an ultraportable ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging and quantitative imaging studies. The ES1 System 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. The ES1 System is operated from the Selected Host multi-touch screen. The ES1 System also allows the user to perform measurements, to capture images, and to generate printable reports.

The ES1 System 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 liver or 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, the ES1 System is designed to measure several quantitative parameters from B Mode imaging: ultrasound attenuation, speed of sound, and compute ultrasound brightness ratio between 2 regions in the image. The results of ES1 quantitative imaging modalities are displayed on the Selected Host monitor.

Here's a breakdown of the acceptance criteria and study information for the ES1 System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document explicitly states that the tests were conducted "on a sample of calibrated phantoms." It does not specify the exact number of phantoms used.

• Data Provenance: The tests were "in-vitro experiments" on phantoms and "on a few subjects in a clinical setting" for B-Mode and Speed of Sound. This indicates a mix of controlled lab settings and limited prospective clinical observation for certain aspects. The country of origin for the data is not specified, but the manufacturing company is E-Scopics S.A.S., France.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not mention the use of experts to establish ground truth for the test set. The ground truth was established by "calibrated phantoms with known reference values."

4. Adjudication Method for the Test Set

Not applicable, as ground truth was established by calibrated phantoms, not human expert consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document focuses on the technical performance of the device against phantoms and comparison with a predicate device, not on human reader performance with or without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the Loop) Performance Study

Yes, the performance data presented is for the standalone algorithm as applied to phantoms. The "Performance Data Discussion" section describes "accuracy and precision of the device ultrasound modalities...tested on calibrated phantoms" and "in-vitro experiments." While "use of the ES1 System on a few subjects in a clinical setting was also demonstrated to be feasible and safe," the quantitative performance metrics (bias, precision, correlation) are derived from the in-vitro phantom studies.

7. Type of Ground Truth Used

The ground truth used for the quantitative measurements (Speed of Sound, Shear Wave Speed/Stiffness, Ultrasound Attenuation) was derived from known reference values of calibrated phantoms. For B-Mode, it involved "distinguish[ing] targets having a contrast ratio of +/- 3 dB as compared to the phantom background," and assessing resolution (axial and lateral).

8. Sample Size for the Training Set

The document does not provide any information about the sample size for a training set. This typically implies that the device's algorithms were developed without a distinct "training set" in the machine learning sense, or that the training data details were not part of this 510(k) summary. The development may have relied on established physics-based algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no information regarding a training set is provided.

Ask a specific question about this device