(29 days)
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, trans-esophageal, 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 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 pediatic patients.
The ACUSON S3000, S2000, S1000 Ultrasound Systems are a multi-purpose mobile, software controlled diagnostic ultrasound system with and 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, M-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 text is a 510(k) premarket notification for the SIEMENS HEALTHCARE ACUSON S2000 S2000 S1000 Diagnostic Ultrasound Systems. It primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or specific reported device performance metrics in a table format as might be seen for an AI/ML device validating a specific diagnostic output. Instead, it justifies substantial equivalence by stating that the new device's features and characteristics are consistent with predicate devices and comply with relevant safety and performance standards.
The acceptance criteria are implicitly met by:
- Identical Indications for Use: The current devices (ACUSON S3000, S2000, S1000) share the exact same stated "Indications for Use" as their predicate device (Acuson S3000, S2000, S1000 K163635) across a wide range of clinical applications. This implies that the device is expected to perform equivalently for these applications. The table from the document highlighting the identical indications for use is presented below.
- Compliance with Recognized Standards: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, and thermal, electromagnetic, and mechanical safety, conforming to applicable medical device safety standards like AIUM/NEMA UD-3, AIUM/NEMA UD-2, IEC 62359, UL/IEC 60601-1, AAMI/ANSI ES 60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, and ISO 10993-1. These standards serve as inherent acceptance criteria for the safety and foundational performance of the device.
- Technological Characteristics: The document lists numerous features (e.g., B-mode, M-mode, PWD, CWD, Color Doppler, Amplitude Doppler, various imaging technologies like SieScape, 3-Scape, TEQ, etc.) that are identical to the predicate device. This implies that the performance of these features is expected to be equivalent to the cleared predicate.
Since this is a 510(k) for an ultrasound system, not an AI/ML diagnostic tool with specific quantifiable output for clinical decision-making, direct "acceptance criteria" and "reported device performance" in terms of clinical accuracy (e.g., sensitivity, specificity) are not described for novel AI functions. The basis of clearance is substantial equivalence to legally marketed predicate devices, meaning it performs as safely and effectively as those devices for their stated indications.
Table of Comparison with Predicate Device (Implicit Acceptance Criteria)
| Feature / Characteristic | Acuson S3000, S2000, S1000 (New Device) | Acuson S3000,S2000, S1000 K163635 (Predicate) | QLAB K132165 (Predicate) | Device Meets Acceptance? |
|---|---|---|---|---|
| Indications for Use: | ||||
| ■ Fetal | √ | √ | Yes (Equivalent) | |
| ■ Abdominal | √ | √ | Yes (Equivalent) | |
| ■ Intraoperative abdominal and vascular | √ | √ | Yes (Equivalent) | |
| ■ Intraoperative neurological | -- | -- | Yes (Equivalent, not present) | |
| ■ Pediatric | √ | √ | Yes (Equivalent) | |
| ■ Small Organ | √ | √ | Yes (Equivalent) | |
| ■ Neonatal cephalic | √ | √ | Yes (Equivalent) | |
| ■ Adult Cephalic | √ | √ | Yes (Equivalent) | |
| ■ Cardiac | √ | √ | Yes (Equivalent) | |
| ■ Trans-esophageal | √ | √ | Yes (Equivalent) | |
| ■ Transrectal | √ | √ | Yes (Equivalent) | |
| ■ Transvaginal | √ | √ | Yes (Equivalent) | |
| ■ Peripheral vessel | √ | √ | Yes (Equivalent) | |
| ■ Laparoscopic | -- | -- | Yes (Equivalent, not present) | |
| ■ Musculo-skeletal (conventional) | √ | √ | Yes (Equivalent) | |
| ■ Musculo-skeletal (superficial) | √ | √ | Yes (Equivalent) | |
| Center Frequencies Supported: | ||||
| (Various frequencies listed, all identical) | √ | √ | Yes (Equivalent) | |
| Modes: | ||||
| ■ B | √ | √ | Yes (Equivalent) | |
| ■ Parallel processing in B mode | √ | √ | Yes (Equivalent) | |
| ■ M | √ | √ | Yes (Equivalent) | |
| ■ PWD (Pulsed Wave Doppler) | √ | √ | Yes (Equivalent) | |
| ■ CWD (Continuous Wave Doppler) | √ | √ | Yes (Equivalent) | |
| ■ D (Color Doppler) | √ | √ | Yes (Equivalent) | |
| ■ Amplitude Doppler | √ | √ | Yes (Equivalent) | |
| ■ Combined (BMDC) | √ | √ | Yes (Equivalent) | |
| Features: | ||||
| ■ Quad processing in color | √ | √ | Yes (Equivalent) | |
| ■ Native™ tissue harmonic imaging | √ | √ | Yes (Equivalent) | |
| ■ SieScape™ panoramic imaging | √ | √ | Yes (Equivalent) | |
| ■ Color SieScape™ panoramic imaging | √ | √ | Yes (Equivalent) | |
| ■ 3-Scape™ real-time 3D imaging | √ | √ | Yes (Equivalent) | |
| ■ fourSight™ 4D transducer technology | √ | √ | Yes (Equivalent) | |
| ■ TEQ™ ultrasound technology | √ | √ | Yes (Equivalent) | |
| ■ Cardiac Imaging physiological signal display | √ | √ | Yes (Equivalent) | |
| ■ syngo ® Auto OB measurements | √ | √ | Yes (Equivalent) | |
| ■ Advanced SieClear™ spatial compounding | √ | √ | Yes (Equivalent) | |
| ■ STIC (Fetal Heart Imaging) | √ | √ | Yes (Equivalent) | |
| ■ Amnioscopic rendering | √ | √ | Yes (Equivalent) | |
| ■ Cadence contrast agent imaging | √ | √ | Yes (Equivalent) | |
| ■ Contrast Dynamics | √ | (blank) | √ | Yes (Equivalent to QLAB predicate) |
| ■ Clarify™ vascular enhancement technology | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ eSie™ Touch elasticity imaging | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ syngo ® Auto Left heart | Tested to ISO 10993-1 | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ syngo ® Velocity Vector Imaging | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ Semi Auto-segmentation (eSie Calc) | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ Custom Tissue Imaging / Speed of Sound | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ VTI (S2000, S3000) | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ VTIQ (S2000, S3000) | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ VTQ (S2000, S3000) | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ AHP | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ Monitor: 19" FPD | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| ■ eSie Fusion | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| Output Display Standard (Track 3) | √ | √ | (blank) | Yes (Equivalent to K163635 predicate) |
| Patient Contact Materials | Tested to ISO 10993-1 | Tested to ISO 10993-1 | (blank) | Yes (Equivalent) |
| UL 60601-1 Certified | √ | √ | (blank) | Yes (Equivalent) |
2. Sample size used for the test set and the data provenance
The document states: "Since the ACUSON S3000, S2000, S1000 Ultrasound Systems use the same technology and principles as existing devices, clinical data is not required." This indicates that no specific test set or clinical study was conducted for this 510(k) submission to demonstrate performance on new data. The primary method of demonstrating substantial equivalence was through comparison with predicate devices and compliance with non-clinical performance standards.
Therefore, information on sample size, country of origin, or retrospective/prospective nature of a test set is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no specific clinical test set was used for this submission, there is no mention of experts establishing ground truth for a test set. The device relies on the established safety and efficacy of its predicate devices and compliance with engineering standards.
4. Adjudication method for the test set
Not applicable, as no dedicated test set requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
No, an MRMC study was not conducted or referenced, as clinical data was deemed not required due to substantial equivalence claims to existing devices with the same technology and principles. Therefore, there's no reported effect size of how human readers improve with AI vs. without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not an AI/ML product in the context of "algorithm only" performance. It is a diagnostic ultrasound system. Its performance evaluation is based on meeting safety and performance standards and being substantially equivalent to existing ultrasound systems, not on a standalone algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.)
No specific "ground truth" as typically defined for AI/ML diagnostic performance studies (e.g., expert consensus, pathology, outcomes data) was used or required for this 510(k) submission. The substantial equivalence argument relies on the inherent capabilities and safety profiles of the technological principles and features that are identical to previously cleared devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device submission.
§ 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.