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The LOGIQ V ! / LOGIQ V2 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculoskeletal Conventional & Superficial; Urology; Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g. Nerve Block, Vascular Access, Tissue Biopsy/Fluid Drainage).

The LOGIQ V1 / LOGIQ V2 systems are a laptop ultrasound console approximately 120mm in height, 368mm in width and 396mm in length with integrated keyboard, a color video LCD type display, one inbuilt active probe ports and two probe port adapters. It has digital acquisition, processing and display capability and operates from an integrated battery or separate power supply/charger. LOGIQ V1 and LOGIQ V2 have the same hardware and system features.

The provided document is a 510(k) Premarket Notification from the FDA for GE Medical Systems' LOGIQ V1/LOGIQ V2 ultrasound systems. This document primarily focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with detailed acceptance criteria and testing methodology for a novel AI/CAD device.

Therefore, the specific information requested regarding acceptance criteria, device performance data, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this document.

The document states:
"Summary of Clinical Tests: The subject of this premarket submission, LOGIQ V1 / LOGIQ V2, did not require clinical studies to support substantial equivalence." (page 15)

This indicates that a performance study with the requested details was not conducted or submitted for this particular FDA clearance, as the device was deemed substantially equivalent to predicates based on technological characteristics and safety standards.

The document lists the product as an "Ultrasonic pulsed doppler imaging system" (21 CFR 892.1550). It's a general-purpose ultrasound system (hardware), not specifically an AI or CAD device with performance metrics based on diagnostic accuracy.

Given the information provided, I cannot populate the table or answer the specific questions about acceptance criteria and study details.

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