(22 days)
The ACUSON Sequoia ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Fetal. Abdominal. Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.
The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.
The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal 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 ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M Mode, Doppler Tissue Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.
The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria through a rigorous clinical or standalone study. Instead, it is a 510(k) summary for a medical device (ACUSON Sequoia Diagnostic Ultrasound System) seeking substantial equivalence to previously cleared predicate devices.
The document primarily focuses on demonstrating that the new device shares the same intended use and technological characteristics as the predicate devices, with minor modifications (like new transducers and software features that were already cleared for other transducers/devices).
Therefore, I cannot extract the requested information (like a table of acceptance criteria, sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC study results, or detailed standalone performance) because the document explicitly states:
- "Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (Section 8)
This means the submission relies on the established safety and effectiveness of the predicate devices and general compliance with performance and safety standards, rather than new performance studies with specific acceptance criteria.
The information closest to what you requested, but not a direct answer, is the list of features where the submission device and its predicate are compared (Table in Section 6). This table shows that features are present (marked with '√') but does not specify quantitative acceptance criteria or performance metrics for those features.
If this were a submission for an AI/ML-driven device requiring performance validation, the content would be significantly different and would include the types of studies and criteria you've listed. As it stands, this is a traditional 510(k) for an ultrasound system primarily focused on demonstrating substantial equivalence to prior versions.
§ 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.