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The Advantx LVC+ x-ray imaging system is intended to be used for general purpose diagnostic angiographic fluoroscopy and radiographic studies.

The Advantx LCV+ imaging system is an angiographic positioner with a 32 cm intensifier, for use with a vascular table and an x-ray system.

The provided document is a 510(k) summary for the GE Advantx LCV+ X-ray Imaging System, submitted in 1996. This document does not contain any information regarding acceptance criteria for device performance or a study proving that the device meets such criteria.

The summary primarily focuses on the device's indications for use, description, marketing history, and a general statement about safety, comparing it to existing diagnostic X-ray systems. It mentions a "Hazards Analysis" and "Failure Mode and Effects Analysis (FMEA)" to control potential hazards and ensure performance to specification and Federal Regulations, but it does not specify what those performance specifications are or how they were demonstrated.

Therefore, I cannot fulfill the request to describe the acceptance criteria and a study proving the device meets them based on the provided text. The requested information regarding a table of acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not present in this 510(k) summary.

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