(80 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, transrectal, 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 option to reference normative tables that have been validated 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-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.
Virtual Touch Imaging and eSie Touch Elastography provide qualization of relative stiffness between tissues with different elastic properties.
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. It is substantially equivalent to the S2000 (K111674) and S3000 system (K121138) which are legally marketed devices.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Siemens Medical Solutions Acuson S2000 and S3000 Diagnostic Ultrasound Systems:
The document is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo performance criteria or conducting extensive clinical trials for new applications. As such, the information provided is geared towards proving that the new device performs as well as or similarly to existing cleared devices.
Based on the provided text, the key "device" being discussed is the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, including various transducers and software features like Virtual Touch Imaging (VTI) and eSie Touch Elastography.
1. Table of Acceptance Criteria and Reported Device Performance
Note: This document does not explicitly state quantitative acceptance criteria in the way one might expect for a new performance claim (e.g., "sensitivity must be >X%"). Instead, the primary "acceptance criterion" demonstrated throughout this 510(k) submission is substantial equivalence to predicate devices. The "reported device performance" is essentially that the new device operates similarly and safely.
The document highlights the features and indications for use as being equivalent to previously cleared devices.
| Acceptance Criterion (Implicit: Substantial Equivalence via Feature/Performance Comparison) | Reported Device Performance (as demonstrated by comparison) |
|---|---|
| Indications for Use (General Ultrasound Applications) | Identical to predicate devices (Acuson S2000 K111674, S3000 K121138, Acuson Antares K063138, Acuson S3000 K122825). Covers Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications. |
| Technological Characteristics (Modes, Frequencies, Features) | Confirmed to be consistent with or improved from predicate devices. Specifically, modes (B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined) and a range of center frequencies (2.0 MHz to 10.0 MHz) are available, matching or expanding on predicates. Features like Native™ tissue harmonic imaging, SieScape™ panoramic imaging, 3-Scape™ real-time 3D, TEQ™ ultrasound technology, etc., are also present. |
| Safety (Acoustic Output, Biocompatibility, Electrical, Thermal, Mechanical, EMC) | Device evaluated and found to conform with applicable medical device safety standards (e.g., UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, UD-2, 93/42/EEC, EN/IEC 60601-1-1/2, IEC 1157, ISO 10993-1). Cleared patient contact materials, electrical, and mechanical safety are unchanged. |
| Performance for Elastography (Virtual Touch Imaging - VTI) | "Additional testing was performed to compare EI to VTI by validating intra-operator and inter-operator reproducibility of VTI using EI as a benchmark. Visual comparison of phantom images generated with EI and VTI demonstrate more consistent contrast to noise ratio and clearer inclusion visualization with VTI than with EI." (This implies a qualitative improvement, not a quantitative acceptance metric.) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a number of cases or patients. The document refers to "phantom images" for the elastography comparison.
- Data Provenance: Not specified for the phantom study (e.g., no country of origin, no mention of retrospective or prospective data collection from human subjects). It's a non-clinical test.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable, as expert involvement for establishing ground truth on a test set (clinical data) is not mentioned. The primary comparison for elastography was qualitative visual comparison of phantom images.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No mention of multiple readers or an adjudication process for clinical ground truth. The comparison for elastography (EI vs VTI) was described as "visual comparison of phantom images."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done?: No. The document states: "The S2000 and S3000 use the same technology and principles as existing devices, clinical data is not required." This explicitly indicates that a comparative effectiveness study involving human readers and clinical data was not performed or submitted for this 510(k).
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as no MRMC study was conducted.
6. Standalone (Algorithm Only) Performance
- Standalone Performance Done?: Not in the typical sense of a quantitative diagnostic system evaluated against clinical ground truth. The "additional testing" for Virtual Touch Imaging (VTI) involved a "visual comparison of phantom images generated with EI and VTI." This is a qualitative assessment of the image quality and reproducibility on a phantom, not a standalone diagnostic performance metric on a clinical dataset. The system itself is a diagnostic ultrasound, implying direct human operation rather than a standalone algorithm providing a diagnostic output independently.
7. Type of Ground Truth Used
- Type of Ground Truth:
- For the overall device, the implicit ground truth is substantial equivalence to legally marketed predicate devices. This means the new device is compared to existing devices known to be safe and effective.
- For the specific feature of Virtual Touch Imaging (VTI), the "ground truth" for comparison was the Established Imaging (EI) technique on phantoms, and the assessment was "visual comparison" for "more consistent contrast to noise ratio and clearer inclusion visualization." This isn't a pathological or outcome-based ground truth, but a comparative image quality assessment on a controlled phantom.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document describes a medical device undergoing premarket notification (510(k)), not an AI/ML algorithm development with distinct training and test sets as typically understood. The device is an ultrasound system with advanced imaging features.
9. How Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable. See point 8.
§ 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.