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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, Musculoskeletal and Peripheral Vascular applications.

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 and Harmonic Imaging on a Display.

I am sorry, but the provided text does not contain the specific information required to answer your request.

Here's why:

• Acceptance Criteria and Reported Device Performance: The document is a 510(k) summary for a diagnostic ultrasound system (ACUSON Sequoia). While it lists various capabilities and features (e.g., modes of operation, clinical applications), it does not provide quantitative acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy, or any numeric scores) for how well the device performs these functions. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
• Study Details: Since no specific performance claims or acceptance criteria are stated, there is no detailed study described that proves the device meets such criteria. 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." This indicates that a pivotal clinical trial demonstrating performance against specific endpoints was not part of this submission for clearance.
• Missing Information: Consequently, all the other requested details such as sample size, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, ground truth type, and training set information are not present in this document because no such performance study is detailed.

The document focuses on establishing substantial equivalence based on:

1. Indications for Use: The system is intended to provide images and signals for various clinical applications (Fetal, Abdominal, Pediatric, Neonatal Cephalic, Small Parts, OB/GYN, Cardiac, Pelvic, Vascular, Musculoskeletal, and Peripheral Vascular).
2. Technological Characteristics: Comparison of modes, frequencies, and features with predicate devices.
3. Safety and Compliance: Adherence to various IEC and ISO standards for acoustic output, biocompatibility, electrical safety, etc.

It operates under the assumption that since the technology and intended use are substantially equivalent to previously cleared devices, explicit performance studies comparing against rigid acceptance criteria are not necessary for this 510(k) clearance.

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