(27 days)
The 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, small organ, neonatal cephalic, adult cephalic, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) 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 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 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 ultrasound systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with and on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. The 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 is a 510(k) Summary for the Siemens Medical Solutions ACUSON S1000, S2000, S3000 Diagnostic Ultrasound System. It asserts substantial equivalence to previously cleared devices (K152369) and does not describe acceptance criteria or a study proving the device meets specific acceptance criteria in the typical sense of a novel algorithm with performance metrics.
Instead, the submission focuses on demonstrating that the modified systems have the same intended use and technological characteristics as their previously cleared counterparts, and that they conform to established medical device safety standards. Therefore, the "acceptance criteria" here refer to conformance with those safety standards and the equivalence of intended use and technological features.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present quantitative acceptance criteria or performance metrics for a novel algorithm. Instead, it asserts equivalence to previously cleared devices and compliance with general safety and performance standards.
| Acceptance Criterion (Implicit) | Reported Device Performance (Implicit Conformance) |
|---|---|
| Same intended use as predicate device (K152369) | Met: Explicitly stated that "The modified Acuson S1000, S2000, S3000 Ultrasound Systems are the same as the company's own previously cleared Acuson S1000, S2000, S3000 Ultrasound Systems (K152369) with regard to both intended use and technological characteristics." |
| Conformance to UL 60601-1 (Safety) | Met: Explicitly states "UL 60601-1 Certified" and "The system complies with the following voluntary standards: UL 60601-1". |
| Conformance to IEC 60601-2-37 (Diagnostic Ultrasound Safety) | Met: Explicitly states "IEC 60601-2-37 Diagnostic Ultrasound Safety Standards." |
| Conformance to CSA C22.2 No. 601-1 (Safety) | Met: Explicitly states "CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment." |
| Conformance to AIUM/NEMA UD-3 (Thermal and Mechanical Acoustic Output) | Met: Explicitly states "AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment." |
| Conformance to AIUM/NEMA UD-2 (Acoustic Output Measurement) | Met: Explicitly states "AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound." |
| Conformance to 93/42/EEC Medical Devices Directive | Met: Explicitly states "93/42/EEC Medical Devices Directive." |
| Conformance to EN/IEC 60601-1, 60601-1-1, 60601-1-2 (Safety and EMC) | Met: Explicitly states various EN/IEC 60601 standards. |
| Biocompatibility (ISO 10993-1) | Met: Explicitly states "Tested to ISO 10993-1." |
| Software Release Verification | Met: "Testing was performed to verify the software release." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission is for an updated version of a previously cleared device, not a novel AI algorithm requiring a new clinical performance study with a test set of patient data. The non-clinical tests mentioned (e.g., electrical safety, biocompatibility) do not typically involve patient data test sets with provenance.
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)
Not applicable. As noted above, this submission relies on demonstrating equivalence to an existing device rather than a clinical performance study with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No new clinical performance study was conducted that would require adjudication.
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
Not applicable. No MRMC study was done, as this is a 510(k) for an updated ultrasound system, not an AI-powered diagnostic aide requiring a comparative effectiveness study. The document explicitly states: "Since the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm with standalone performance being evaluated. It's a diagnostic ultrasound system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. New clinical ground truth was not established for this 510(k) submission. The safety and performance are based on compliance with standards and equivalence to the predicate device.
8. The sample size for the training set
Not applicable. There is no mention of an AI algorithm or a training set in this submission.
9. How the ground truth for the training set was established
Not applicable. There is no mention of an AI algorithm or a training set in this 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.