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The MobiUS Ultrasound Imaging System is indicated for ultrasound imaging, measurement and analysis of the human body for the following clinical applications: fetal/OB, abdominal, cardiac, pelvic, pediatric, musculoskeletal, and peripheral vessel imaging. Its compact size, portability and user interface enable it for use in primary care and special care areas.

The MobiUS Ultrasound Imaging System is a compact, portable ultrasound imaging system consisting of a handheld ultrasound probe, cable, host computer and user interface. The ultrasound probe and cable is one of the five models of the INTERSON USB Ultrasound Imaging Probe, ranging from 3.5 MHz to 12.0 MHz. The probes consist of a single-element mechanical sector scanner that contains the ultrasound generator and receiver, analog-todigital converter, microcontroller, control logic, USB 2.0 interface and control within the hand piece. It has a push button control to activate scanning. The probe is connected via a USB cable to a host computer. The host computer comes preloaded with the MobilUS software which utilizes an icon touch-based user interface. The software enables ultrasound image capture and review, image controls for near, mid, and far gain, as well as image intensity and contrast, linear measurement, storage and transmission of images and videos. The MobiUS Ultrasound Imaging System allows the user to image in real-time and review cine or freeze-frame images on the screen in B-Mode scan format.

The provided text does not contain information about acceptance criteria or a study proving that the "MobiUS Ultrasound Imaging System" device meets specific acceptance criteria. This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against defined acceptance criteria through a clinical or performance study.

The document lists the intended uses and technical characteristics of the MobiUS Ultrasound Imaging System and its various transducers, comparing them to previously cleared predicate devices (INTERSON USB Ultrasound Probe System, GE VScan Diagnostic Ultrasound System, Signos Personal Ultrasound).

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on a standalone performance study.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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