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The MySono U5 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, Obstetrics, Gynecology, Musculoskeletal, Small Parts, Vascular, Cardiac, Pediatric Cardiology, TCD and Urology applications.

The MySono U5 is a hand-held, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D Mode, M Mode, Color Doppler Mode (C Mode), Power Doppler Mode (PD Mode), and PW Spectral Doppler Mode (D Mode), 3D imaging mode or as a combination of these modes. The MySono U5 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The provided document is a 510(k) summary for the MySono U5 Diagnostic Ultrasound System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the performance of a novel device against specific acceptance criteria through a clinical study. As such, the document does not contain the detailed clinical study information requested.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The document primarily focuses on establishing substantial equivalence by demonstrating that the MySono U5 has similar technological characteristics and intended uses as the predicate devices (SONOACE X8 and SONOACE PICO). It lists the intended uses and the various operating modes for different clinical applications for the system and its associated transducers (3D2-6, C3-7, EV4-9, L5-12, P2-4).

The acceptance criteria mentioned are general product safety standards (e.g., UL 60601-1, IEC60601-2-37, EN/IEC60601-1-2) and acoustic output measurement standards (NEMA UD 2-2004, NEMA UD 3-2004, IEC 61157), and biocompatibility (ISO10993). These are engineering and safety standards, not clinical performance metrics. The fact that the device has been designed to meet these standards is stated, implying adherence, but no specific performance data or study details demonstrating compliance with these standards within the context of a clinical study are provided in this K summary.

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