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The RT55 portable ultrasound diagnostic system is intended for use in obstetrics, gynecology and general radiology examinations by a qualified physician to aid in the diagnosis and evaluation of soft tissues by generating two dimensional images, time-motion images and biometric data. The specific intended uses of this system include: abdominal, small parts, pediatric and fetal imaging.

The RT55 is a portable ultrasound system weighing less than 10 kg .. approximately 28 cm wide, 41 cm deep and 29 cm high with integrated monitor and keyboard. The system is designed for use in linear and convex scanning modes and supports linear, convex and micro convex probes.

The provided text is a 510(k) Summary for the GE RT55 Diagnostic Ultrasound System, dated July 20, 1995. It details the device's identification, contact information, predicate device comparison, and a summary of studies. However, the document does not contain the information required to answer the specific questions about acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is missing:

• No Acceptance Criteria or Performance Data: The document states, "The device has been evaluated for acoustic output, biocompatibility, and thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." However, it does not specify what those standards are, what the acceptance criteria were for conforming to them, or what the reported device performance was against those criteria.
• No Clinical Study Details: The document mentions "Diagnostic ultrasound has accumulated a long history of safe and effective performance," but it does not describe a specific study conducted for the GE RT55 that would include details like sample size, ground truth establishment, expert qualifications, or adjudication methods. The "Summary of Studies" pertains to safety (acoustic output, biocompatibility, electrical safety) and states the device "conforms with applicable medical device safety standards," but doesn't provide performance data relevant to diagnostic accuracy.
• No AI Component: This device is an ultrasound system from 1995. AI/ML-based diagnostic devices and their associated evaluation methodologies (like MRMC studies for AI improvement) were not a consideration at this time.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems RT2800) based on design, construction, materials, intended uses, and operating modes, along with general safety compliance, rather than presenting a detailed clinical performance study with defined acceptance criteria.

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