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The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular.

The system also provides the ability to measure anatomical structures (abdominal, small organs, musculoskeletal, superficial musculoskeletal and peripheral vascular).

The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a linear array transducer to produce images 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 and associated calculations, 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 external domes (subm as the predicate devices (see section 4.5.2 for predicate devices) and transducers for the imaging modes: B-Mode imaging, Color Flow imaging, Color Power imaging, Pulsed Wave Doppler, and Elastography Imaging.

This document is a 510(k) summary for the SuperSonic Imagine AIXPLORER® Ultrasound System. It mostly focuses on substantial equivalence to predicate devices and safety considerations for an ultrasound system, not the performance of an AI application. Therefore, most of the requested information regarding acceptance criteria and the study proving an AI device meets these criteria is not available in the provided text.

Specifically, the document does not contain details about:

• Acceptance criteria for an AI device's performance.
• A study validating the performance of an AI component, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance studies for an AI algorithm.
• Ground truth types or training set details for an AI component.

The document primarily describes a diagnostic ultrasound system and its general features, modes of operation, and acoustic output limits, comparing them to legally marketed predicate devices. The "AIXPLORER" name refers to the ultrasound system itself, not necessarily an AI-powered diagnostic tool in the sense of an algorithm making clinical interpretations. The only mention of "AI" is within the trade name "AIXPLORER®".

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study proving an AI device meets these criteria based on the provided text. The document does not describe such acceptance criteria or a study for an AI component.

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