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Ultrasound imaging or fluid flow analysis of the human body as follows: General Imaging and Cardiology for Fetal, Abdominal, Intraoperative (abdominal and neurological), Pediatrics, Small Organs (breast, thyroid, penis and prostate), Neonatal/Adult Cephalic, Cardiac (adult, pediatric and neonatal), Trans-esophageal, Transrectal, Transvaginal, Peripheral Vessel, and Musculo-skeletal (superficial and conventional) applications, and intended uses as defined in the FDA guidance document. The system also provides for the measurement of anatomical structures and analysis packages that provide information that is used for clinical diagnosis purposes.

The Sequoia is a general purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for thermal and mechanical indices related to potential bioeffect 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) wave Doppler mode, color Doppler mode. Power Amplitude Doppler mode, a combination of these modes, Harmonic Imaging, or 3D imaging, on a CRT display.

The provided text is a 510(k) Summary for the Siemens Medical Solutions USA, Inc. Sequoia Diagnostic Ultrasound System. It describes the device, its intended uses, and lists safety standards it conforms to. However, it does not contain any information about acceptance criteria, specific performance studies, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment methods.

The document primarily serves to establish substantial equivalence to a predicate device (Sequoia Diagnostic Ultrasound System Signature II, K022567) and outlines the approved clinical applications and imaging modes for various transducers. The tables presented are "Indications for Use Forms," indicating what the device is cleared for, not how its performance was evaluated against specific criteria.

Therefore, I cannot provide the requested information from the given text. The text explicitly states "This summary of safety and effectiveness is provided as part of this Premarket Notification in compliance with the Safe Medical Device Act of 1990 revisions to 21 CFR, Part 807.92, Content and Format of a 510(k) Summary," which typically focuses on substantial equivalence rather than detailed performance study results.

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