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The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, and Non-invasive Cardiac.

The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, Intraoperative, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal/Adult Cephalic, Fetal/Obstetrics, Cardiac).

The SuperSonic Imagine AIXPLORER® system is a cart based utrasound imaging system used to perform non-invasive diagnosic general purpose ultrasound imaging studies a scan converter and can be coupled to a variety of finear, curved, micro-convex, and motorized linear and phased array transas, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system function to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFF-ColorFlow Imaging- also called Amplitude Doppler, dCPI, and Angio PLU,S). Pulsed Wave Doppler, 3D imaging and for ShearWaye™ elastography.

This document is a 510(k) summary for the SuperSonic Imagine AIXPLORER® Ultrasound Diagnostic System, indicating that clinical data was not required for its clearance because it uses the same technology and principles as its predicate devices. Therefore, the document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria derived from a human-in-the-loop or standalone AI performance study.

Specifically, section 8 of the summary (page 24) explicitly states: "Clinical data is not required as the Aixplorer® System uses the same technology and principles as predicate devices."

As a result, I cannot provide the requested information, which would typically be found in a clinical study report for an AI/ML medical device. This 510(k) submission is for a conventional ultrasound system, not an AI-powered diagnostic device in the way a modern AI/ML submission would be.

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