(34 days)
The 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 Ultrsound 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 S3000™ Ultrasound System is 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 document is a 510(k) premarket notification for the Siemens Acuson S3000 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data to prove novel acceptance criteria.
Therefore, the document explicitly states that clinical data is not required because the S3000 uses the "same technology and principles as existing devices." This means there isn't a specific study outlined in this submission that defines and proves novel acceptance criteria for the device's performance through clinical trials. Instead, the "acceptance criteria" are implied by conformance to existing safety and performance standards for diagnostic ultrasound systems and demonstrating substantial equivalence to predicate devices already on the market.
Given this, I cannot provide detailed answers to many of your specific questions, as they pertain to clinical studies with ground truth establishment, expert adjudication, and statistical performance metrics, which are not typically part of a 510(k) submission for a device demonstrating substantial equivalence to well-established technology like an ultrasound system.
However, I can extract the information that is present and relevant to the "acceptance criteria" and "study" as implied by the 510(k) process.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, there isn't a table of novel acceptance criteria with reported performance from a specific clinical study for this device. Instead, the acceptance criteria are met by:
- Conformance to established safety and performance standards.
- Demonstration of substantial equivalence to predicate devices (Acuson Antares and S2000 Ultrasound Systems, and specific transducers from those systems). The document implies that the performance of the S3000 is "substantially equivalent" to these cleared devices, meaning it performs as well as, or comparably to, devices already deemed safe and effective.
The table below outlines the general characteristics and features of the Acuson S3000 compared to its predicate devices, demonstrating how it meets the "acceptance criteria" of being substantially equivalent. "Reported device performance" in this context refers to the presence of capabilities and adherence to standards, aligning with the predicates.
| Feature / Characteristic | Acceptance Criteria (Implied by Predicate Equivalence & Standards Conformance) | Reported Device Performance (Acuson S3000) |
|---|---|---|
| Indications for Use | Must align with or be a subset of predicate device indications. | Broad range of applications (Fetal, Abdominal, Cardiac, Vascular, etc.), consistent with predicates. Explicitly lists all indications as "√" (included) or "N" (new, but implicitly equivalent by technical characteristics). |
| Center Frequencies | Must support a range of clinically relevant frequencies similar to predicates. | Supports frequencies from 2.0 MHz to 10.0 MHz, consistent with predicates. |
| Modes | Must support standard ultrasound imaging modes (B, M, Doppler, etc.). | Supports B, M, PWD, CWD, Color Doppler, Amplitude Doppler, and Combined modes, consistent with predicates. |
| Special Features | Must include features similar to or enhanced but equivalent to predicates. | Includes various advanced features like Quad processing in color, Native™ tissue harmonic imaging, SieScape™ panoramic imaging, 3-Scape™ real-time 3D, fourSight™ 4D, TEQ™ ultrasound, syngo® Auto OB measurements, Advanced SieClear™, STIC, Amnioscopic rendering, Cadence contrast agent imaging, Clarify™ vascular enhancement, eSie™ Touch elasticity imaging, syngo® Auto Left heart, syngo® Velocity Vector Imaging, Semi Auto-segmentation, Custom Tissue Imaging/Speed of Sound, AHP, and 19" FPD monitor. Many are marked as also present in the K111674 S2000 predicate. |
| Biocompatibility | Must conform to ISO 10993-1. | "Tested to ISO 10993-1" |
| Electrical Safety | Must conform to UL 60601-1. | "UL 60601-1 Certified" |
| Acoustic Output | Must conform to AIUM/NEMA UD-3 and UD-2. | Device has been evaluated for acoustic output and conforms to these standards. |
| Cleaning/Disinfection | Must meet established effectiveness for cleaning and disinfection. | Device has been evaluated for cleaning and disinfection effectiveness. |
| EMC/Mechanical Safety | Must conform to IEC 60601-1-2 and other relevant IEC standards. | Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2. |
| Quality System | Manufacturer's process must conform to 21 CFR 820 and ISO 13485:2003. | "The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Since the S3000 uses the same technology and principles as existing devices, clinical data is not required." Therefore, there is no test set of clinical data used in this 510(k) submission, and consequently, no relevant information on sample size or data provenance. The assessment for substantial equivalence is based on technical comparisons, non-clinical tests (safety, EMC, etc.), and adherence to established standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
As no clinical test set was required or submitted, there is no information provided on experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As no clinical test set was required or submitted, there is no information provided on an adjudication method.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was conducted or reported in this 510(k) submission. This is a premarket notification for an ultrasound system, not an AI-powered diagnostic device requiring such a study for clinical effectiveness. The document also does not mention AI assistance for human readers in its description of features.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an ultrasound system, not a standalone algorithm. Performance is assessed as a complete system, and no mention of a standalone algorithm (without human operation) is made or relevant here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since no clinical studies with test sets were performed, no ground truth types are mentioned in this submission. The "ground truth" for the device's acceptable performance is implicitly derived from its adherence to safety standards and its substantial equivalence to previously cleared devices.
8. The sample size for the training set
The document does not describe a "training set" in the context of machine learning or AI models. This 510(k) is for a diagnostic ultrasound system based on established technology, not an AI/ML-driven device that typically undergoes "training."
9. How the ground truth for the training set was established
As no "training set" (in the AI/ML context) is discussed, there is no information provided on how ground truth for such a set was established.
§ 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.