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The ultrasound imaging systems are intended for the following applications: Fetal. Abdominal. Intraoperative, Pediatric. Small Parts, Transcranial, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, small organ, neonatal cephalic, adult cephalic, transesophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement; Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The AcuNav Catheter is intended for intraluminal visualization of cardiac and great vessel anatomy and physiology as well as visualization of other devices in the heart of adult and pediative patients. The catheter is intended for imaging guidance only, not treatment delivery, during cardiac interventional percutaneous procedures.

The Quantitative Ultrasound (OUS) software provides the ability to measure the attenuation coefficient in dB/cm-MHz at 3 MHz and the backscatter coefficient in dB/cm-str at 3 MHz in a 3-cm region of interest in the liver. Quantitative Ultrasound also includes the Ultrasonically-Derived Fat Fraction (UDFF) software which provides a 3-cm by 3-cm region of interest measurement tool to report an index that can be useful as an aid to the physician in managing adult patients with hepatic steatosis.

The ACUSON S2000, S3000 Diagnostic Ultrasound Systems are multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

All of the transducers and the catheter based transducers will follow Track 3 acoustic labeling (AIUM 1004, IEC 2007, AIUM/NEMA 2004a) and remain unchanged from the currently cleared ACUSON S-Family systems (K172162).

Only the VTQ application has been modified, all other hardware and software features of the Diagnostic Ultrasound device remain unchanged. Only the ACUSON S2000 and S3000 systems will be updated with the software update to VE11A upon customer purchase of the Quantitative Ultrasound (QUS) application, which will be license controlled. The S1000 system does not support the VTQ application, therefore, will not be configured to support the QUS application.

The ACUSON S3000, S2000 Diagnostic Ultrasound System includes Quantitative Ultrasound (QUS) software that provides the ability to measure the attenuation coefficient (AC) and backscatter coefficient (BSC) at 3 MHz in a 3-cm region of interest in the liver. It also includes Ultrasonically-Derived Fat Fraction (UDFF) software for a 3-cm by 3-cm region of interest measurement that can aid in managing adult patients with hepatic steatosis.

Acceptance Criteria and Device Performance:

The provided document does not explicitly list numerical acceptance criteria for the QUS features (AC, BSC, UDFF) but describes their performance. The acceptance criteria for the QUS functionality appear to be demonstrated by its correlation with established methods and its intended clinical utility.

Study Details:

1. Sample Size and Data Provenance for Test Set:

   • Clinical Study Test Set: 101 participants.
   • Data Provenance: The document doesn't explicitly state the country of origin but refers to an "external clinical study." It is a prospective study as it involved acquiring acoustic property measurements from participants.
   • Phantom Study Test Set: Phantoms with known attenuation and backscatter coefficients. The number of phantoms or measurements is not specified.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not specify the number of experts or their qualifications for establishing ground truth in the clinical study.
   • For the UDFF index, the ground truth reference was MRI Proton Density Fat Fraction (MRI-PDFF), an objective imaging biomarker.
   • For steatosis grading (0, 1, 2, 3), it refers to "% hepatocytes," implying histological assessment, which is typically done by pathologists. No specific number or qualifications are given.

3. Adjudication Method for Test Set:

   • The document does not describe an adjudication method for the test set. For the UDFF index, it relies on a "least squares fit" to MRI-PDFF. For steatosis grades, it appears to rely on histological assessment without mentioning a specific adjudication process among experts.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study is mentioned for the QUS features (AC, BSC, UDFF). The study focuses on the standalone performance and correlation with reference methods.

5. Standalone Performance Study:

   • Yes, a standalone study was performed. The QUS software, including AC, BSC, and UDFF measurements, was evaluated independently.
   • The phantom study assessed the accuracy and precision of AC and BSC measurements.
   • The clinical study assessed the acoustic property measurements (AC and BSC) and the derived UDFF index in relation to MRI-PDFF and histological steatosis grades.

6. Type of Ground Truth Used:

   • Phantom Study: Known nominal values of attenuation and backscatter coefficients.
   • Clinical Study for UDFF: MRI Proton Density Fat Fraction (MRI-PDFF %) measurements were used as the reference standard to establish the UDFF index via a least squares fit.
   • Clinical Study for Steatosis Grading: Histological assessment (percentage of hepatocytes) was used to define steatosis grades (S0, S1, S2, S3), which were then correlated with UDFF and MRI-PDFF values.

7. Sample Size for Training Set:

   • The document does not explicitly specify a separate training set size for the QUS software. The clinical study with 101 participants appears to be used for the development and evaluation of the UDFF index, which is based on a "least squares fit" to MRI-PDFF measurements. This suggests the clinical data was used to train/calibrate the UDFF algorithm.

8. How Ground Truth for Training Set Was Established:

   • Assuming the clinical study data (101 participants) served as the primary data for establishing the UDFF index:
     • MRI-PDFF: This is an objective measurement obtained from magnetic resonance imaging.
     • Steatosis Grade: Defined by the percentage of hepatocytes, which is determined through histological examination (pathology).

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