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The Ultrasound system is intended for use by a qualified physician or allied health professional for ultrasound evaluations. Specific clinical applications include:
Abdominal
Gynecology (including endovaginal)
Obstetric
Cardiac
Small parts (Breast, Testes, Thyroid, etc.)
Urology
Musculoskeletal
Peripheral vascular
Intra-operative
Pediatric
Neonatal (including abdominal and cephalic)
Adult Cephalic

Acclarix AX4/ Acclarix LX4 is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided text is a 510(k) summary for the Acclarix AX4 and Acclarix LX4 Diagnostic Ultrasound Systems. It details the device's intended use and compares it to predicate devices to demonstrate substantial equivalence. However, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, specifically for an AI/ML component.

The document discusses non-clinical tests for electrical safety, electromagnetic compatibility, and acoustic output, as well as biocompatibility. These are standard tests for ultrasound systems and are about the hardware and general safety, not specifically about the performance of an AI/ML algorithm within the device.

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance from this document, nor can I provide details on sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set size for an AI/ML component, as this information is not present in the provided text.

The document explicitly states: "Clinical test: Clinical testing is not required." This further indicates that no studies demonstrating specific clinical performance or AI/ML algorithm effectiveness were conducted or reported in this 510(k) summary.

In summary, the provided text describes the regulatory clearance process for an ultrasound system based on substantial equivalence to existing devices, focusing on hardware safety and performance, not AI/ML algorithm performance.

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