(244 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, transesophageal, transvaginal, peripheral vessel, musculo-skeletal (conventional), musculoskeletal (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 oction 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 Subcinical 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-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.
This document, a 510(k) submission for the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, focuses on establishing substantial equivalence to previously cleared devices rather than demonstrating performance against specific acceptance criteria through a dedicated study for the VTQ feature.
Here's an breakdown based on the provided text, highlighting the absence of some requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria or report device performance in the context of a hypothesis-driven study for the VTQ feature. Instead, it argues for substantial equivalence based on the technological characteristics and intended use being similar to predicate devices. The closest to "performance" is the comparison of features between the Siemens VTQ and the Supersonic Imagine Aixplorer, where the VTQ is positioned as offering a "more consistent shear wave velocity estimation based on our experience in in-vivo studies" and emphasizing its direct measurement of shear wave velocity versus the predicate's Young's modulus.
| Feature / Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (VTQ) |
|---|---|---|
| Comparable Exam Types | Abdomen, Breast, Thyroid | Abdomen, Breast, Thyroid (Matches Predicate) |
| Operating Mode | Single Frame | Single Frame (Different from Predicate's "Low Frame Rate Real Time") |
| Cool Down Period | Variable (~1-3 sec) | Yes (Matches) |
| Push Pulse Sequence | Dual Push Beams | Dual Push Beams (Different from Predicate) |
| Multiple Push Pulse Focal Zones | No (Single focal position tracks with ROI) | No (Matches) |
| Two Dimensional Display with Elasticity ROI | No | No (Different from Predicate - Predicate not cleared in USA) |
| Localized Quantitative Shear Wave Velocity Measurement | Yes - Cleared in USA | Yes (Matches, and seeks clearance for point measurements) |
| Localized Quantitative Young's Modulus Measurement | No | No (Different from Predicate - Predicate not cleared in USA) |
| Localized Shear Wave Velocity Measurement Area | 6C1 HD, 4C1, 4V1: 10mm (h) x 6mm (w); 9L4: 5mm (h) x 6mm (w) | Matches specified dimensions |
| Shear Wave Velocity Measurement Range | 0.5-5.5 m/sec (6C1 HD, 4C1, 4V1); 0.5-8.4 m/sec (9L4) | Matches specified ranges |
| Color Coded Shear Wave Velocity Display | No | No (Different from Predicate) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The S2000, S3000 and Aixplorer use the same technology and principles as existing devices, clinical data is not required." This indicates that no specific test set of patient data was used to demonstrate the performance of the VTQ feature against acceptance criteria. The "experience in in-vivo studies" mentioned in Note 1 is vague and not described as a formal clinical study with a defined sample size or provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Since no specific test set was used for a performance study, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method
Not applicable as no formal test set and ground truth establishment study were performed.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or referenced. The submission is focused on demonstrating substantial equivalence of the device, not comparative effectiveness or human reader improvement with AI.
6. Standalone Performance (Algorithm Only)
The document does not describe a standalone performance study for the VTQ algorithm. The comparisons made are about the operational characteristics and measurement capabilities of the device as a whole, rather than the isolated performance of an algorithm. The "more consistent shear wave velocity estimation based on our experience in in-vivo studies" might hint at internal testing, but it's not a formally described standalone study.
7. Type of Ground Truth Used
No specific ground truth type (e.g., pathology, outcomes data) is mentioned as being used for a performance study of the VTQ feature, given that clinical data was not deemed necessary for the 510(k) submission.
8. Sample Size for the Training Set
There is no mention of a training set or its sample size. This submission is for a medical imaging device with software features, not an AI/ML device that typically requires extensive training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
Summary of the Document's Approach:
The 510(k) submission for the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, particularly concerning the VTQ feature, relies primarily on demonstrating substantial equivalence to existing, legally marketed predicate devices (specifically Supersonic Imagine Shearwave Elastography). This is achieved by:
- Comparing technological characteristics: Detailing how the VTQ feature's operational modes, measurement capabilities, and technical specifications are similar to or offer advancements over the predicate device, while maintaining the same fundamental principles of shear wave elastography.
- Aligning with intended use: Showing that the expanded applications and features (including VTQ) fall within the established indications for use of diagnostic ultrasound systems.
- Compliance with safety standards: Highlighting adherence to various international and national safety and quality standards (UL 60601-1, IEC 60601-2-37, ISO 10993-1, etc.).
Crucially, the submission explicitly states that clinical data (and thus formal studies with acceptance criteria, test sets, ground truth, etc.) was not required for this determination of substantial equivalence because the technology and principles are established. The "studies" referenced are primarily previous 510(k) clearances for the predicate devices and the base S2000/S3000 systems, along with adherence to voluntary standards. "In-vivo studies" are mentioned in a qualitative sense to support claims of consistency but are not presented as formal clinical trials.
§ 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.