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SonoSync is a software solution for live streaming images acquired through ultrasound systems to healthcare professionals for diagnostic image viewing, remote access, review, consultation, quidance, support and education in real time.

It is required to follow the technical and operator requirements in the User Manual.

As users of this remote solution, the healthcare professionals take responsibility for ensuring that image quality, display contrast and ambient light conditions meet the generally accepted practices of the ultrasound imaging.

SonoSync is a software solution that allows medical professionals to stream ultrasound images live, providing real-time access to diagnostic imaging, remote viewing, reviewing, consulting, guiding, supporting, and educating.

SonoSync supports four main features: remote diagnostic viewing and guiding, remote clinical training and education, collaboration, and remote service support.

With permission from the person operating the ultrasound equipment, a remote user can control the ultrasound equipment using a virtual remote touch panel and remote control panel.

Furthermore, under the technical, operational, and environmental conditions described in the manual, healthcare professionals can provide clinical diagnostics at a remote location as if directly using the ultrasound equipment.

The provided text does not contain detailed information about a study that proves the device meets specific acceptance criteria in the format requested. The document is an FDA 510(k) submission summary for SonoSync, a software solution for live streaming ultrasound images.

While it mentions "Pre-set criteria were utilized in validation tests to assess whether remote viewing and reviewing with SonoSync matched the performance of local ultrasound systems," it does not provide the specific acceptance criteria, the reported device performance against those criteria, the sample size or provenance of data, the number or qualifications of experts, adjudication methods, or other detailed study information.

It states:

• "10. Summary of Non-Clinical Testing: Pre-set criteria were utilized in validation tests to assess whether remote viewing and reviewing with SonoSync matched the performance of local ultrasound systems. Specifications for remote displays and required network bandwidth to ensure diagnostic image quality were identified. Labeling materials have been prepared to inform users about the necessary specifications for safely and effectively conducting remote diagnostic reviews and viewing."

This indicates that some testing was performed, but the results, methodology, and specific criteria are not elaborated in this summary. Therefore, I cannot generate the requested table or answer the specific questions about the study design.

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