(22 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, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, transesophageal, transrectal, transvaginal, peripheral vessel, musculo-skeletal (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 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 bioeffect 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.
The provided text is a 510(k) premarket notification for Siemens Medical Solutions USA, Inc.'s Acuson S1000/S2000/S3000 Diagnostic Ultrasound Systems. This document outlines the device's features, intended use, and its substantial equivalence to previously cleared predicate devices. It explicitly states that clinical data is not required for this submission because the systems use the same technology and principles as existing, already cleared devices. Therefore, the document does not contain information about acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, or standalone performance related to new clinical studies to prove the device meets acceptance criteria.
The submission focuses on establishing substantial equivalence based on technological characteristics and intended use compared to its own previously cleared S1000, S2000, and S3000 systems (K140959), and for one accessory (biopsy needle guide) to a guide for the X700 Ultrasound System (K123001).
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly detailed in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than reporting performance against specific acceptance criteria for a novel device. The document states that the device "has been found to conform with applicable medical device safety standards" and "complies with the following voluntary standards." These standards could be considered broad acceptance criteria, but specific performance metrics against those criteria are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not applicable as the document explicitly states: "Since the S1000, S2000, S3000 systems in this submission use the same technology and principles as existing devices, clinical data is not required." Therefore, there was no test set derived from human or animal subjects for performance evaluation in this 510(k) submission.
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 no clinical data or test set requiring expert ground truth was used for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical data or test set requiring adjudication was used for this submission.
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. The document does not mention any AI assistance or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as the device is an ultrasound system and its transducers, not a standalone AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable, as no clinical data was required or used for this submission. The "ground truth" for this submission would be the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
Not applicable, as no new algorithms or clinical training sets were mentioned or required for this submission.
9. How the ground truth for the training set was established
Not applicable, as no new algorithms or clinical training sets were mentioned or required for this submission.
In summary, the provided document demonstrates substantial equivalence through a comparison of technological characteristics and intended use to previously cleared devices, rather than through new clinical performance studies.
§ 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.