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The ACUSON Freestyle™ Utrasound System is intended for diagnostic imaging or fluid flow analysis of the human body including: Fetal. Abdominal, Intraoperative Neurological, Pediatric, Small Organ. Neonatal Cephalic. Cardiac, Peripheral Vessel, Musculoskeletal (Conventional), Musculoskeletal Superficial.

The ACUSON Freestyle™ Ultrasound System is an ultrasound imaging system, which operates with linear, curvilinear, array transducers. The transducers may be used in either a wireless or wired configuration through a cable connected to the system.

The provided text is a 510(k) summary for the ACUSON Freestyle™ Ultrasound System, detailing its substantial equivalence to previously cleared predicate devices. It focuses on the device's technical characteristics, intended use, and compliance with various safety standards.

However, the document explicitly states that "clinical data is not required for substantial equivalence." This means it does not contain information about specific acceptance criteria related to device performance in a clinical setting, nor does it describe a study that proves the device meets such criteria.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and performance studies, including sample size, data provenance, ground truth establishment, or multi-reader multi-case studies, because this type of clinical performance data is not present in the provided text.

The document mainly focuses on comparing the new device's technical specifications and intended uses to those of predicate devices to demonstrate substantial equivalence, rather than providing performance metrics from clinical trials.

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