(196 days)
The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, 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, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information 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 Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.
The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.
The provided document is a 510(k) summary for the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, focusing on their Virtual Touch IQ (VTIQ) shearwave elasticity imaging software. The document primarily establishes substantial equivalence to predicate devices and outlines the device's technical characteristics and intended uses.
Here's an analysis of the requested information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the VTIQ feature. Instead, it argues for substantial equivalence based on technological characteristics and a comparison with the predicate device (Supersonic Imagine Aixplorer).
| Feature / Characteristic | Predicate Device (Aixplorer) | Submission Device (Siemens VTIQ) | Comments / Performance |
|---|---|---|---|
| Shear Wave Elasticity Imaging Software | Aixplorer | VTIQ | Comparable exam types and functionality. Siemens is requesting clearance for point measurements in addition to displaying shear wave velocity on the color bar. Siemens VTIQ is stated to achieve higher signal to noise ratio and more consistent shearwave velocity estimation based on in-vivo studies. |
| Comparable Exam Types | Breast, Thyroid | Breast, Thyroid | - |
| Transducer for same Exam Types | 10L2, 15L4 Linear Array | 9L4 Multi-D Linear Array | - |
| Operating Mode | Low Frame Rate Real Time | Single Frame | VTIQ's single-frame acquisition allows for higher SNR without image compounding, contrasted with the predicate's lower frame rate and need for compounding. |
| Cool Down Period before Live Imaging Resumes | No | Yes (variable, ~3-6 sec) | A difference noted, but not tied to specific acceptance criteria. |
| Push Pulse Beam Density | Low (variable with FOV size) | High (variable with FOV size) | Explained as a factor contributing to higher SNR in VTIQ. |
| Multiple Push Pulse Focal Zones | "Mach Cone" | Yes | Both use for increased radiation force uniformity. |
| Two Dimensional Display with Elasticity Region of Interest | Yes | Yes | - |
| Localized Quantitative Shear Wave Velocity Measurement | Yes - Predicate not cleared in U.S.A. | Yes | Siemens VTIQ requests clearance for this. |
| Localized Quantitative Young's Modulus Measurement | Yes - Predicate not cleared in U.S.A. | No | Siemens chose not to include Young's Modulus due to assumptions needed (tissue density, viscosity) that may not be correct, preferring direct shear wave velocity. |
| Shear Wave Velocity Display Mode | Yes | Yes | - |
| Shear Wave Quality Display Mode | No | Yes | Assists user in interpreting possible shear wave velocity estimate artifacts. |
| Shear Wave Travel Time Display Mode | No | Yes | Improves dynamic range of shear wave image in focal regions of high shear wave velocity. |
| Shear Wave Displacement Display Mode | No | Yes | Provides information on relative shear wave amplitudes, useful for identifying lesion boundaries and correlating with attenuation. |
| Shear Wave Propagation "Movie" (clip) | Yes | No | Siemens uses its own display modes (Quality, Time, Displacement) to visualize shear wave characteristics. |
| Shear Wave Velocity Measurement Range | 0.1-10 m/sec | 0.5-10 m/sec | Siemens opted for a higher lower cutoff (0.5 m/s) to avoid potential artifacts, stating that velocities below this are not encountered in vivo. |
| "See through to B mode" when no shear wave detected | Yes | Yes | - |
| Color Coded Shear Wave Velocity Display | Yes | Yes | - |
| Adjustable Maximum and Minimum Velocity Scale | Yes | Yes | - |
| In Color Code. Red is 'stiff' and blue is 'soft' | Yes | Yes | - |
| Color map is transparent over B mode display | Yes | Yes | - |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a formalized "test set" with a specified sample size for validating the VTIQ feature against acceptance criteria. It mentions:
- "Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers."
- "25 example cases submitted (refer to tab 1.7.5.10 D)."
This suggests some form of comparative evaluation on a limited set of cases (at least 25), but details regarding the design of this study (e.g., sample size, prospective/retrospective, country of origin) are missing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document mentions "biopsy proven breast cancers" as a reference for comparison in the aforementioned "many cases." This implies pathology as ground truth. However, the exact number of experts (e.g., pathologists) involved in establishing this ground truth for the "25 example cases" or more generally for the "many cases" is not specified, nor are their specific qualifications.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set or the "many cases" mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance
The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. It describes a comparison between the VTIQ device and a predicate device, focusing on technical performance differences rather than human reader performance with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
The document implies a standalone comparison of the VTIQ algorithm's output (shear wave velocity, image quality) against the predicate device's output. The statement, "Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers," highlights an algorithm-only comparison of the imaging capabilities and derived measurements.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The primary ground truth mentioned that is relevant to disease state is histopathological diagnosis ("biopsy proven breast cancers").
8. The Sample Size for the Training Set
The document does not provide information on a specific training set or its sample size. This filing is a 510(k) for an ultrasound system with new software features, implying that the VTIQ algorithm was likely developed internally and possibly trained on proprietary data which is not described in this summary.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, how its ground truth was established is also not available in the document.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.