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Routine Radiolgraphic/Fluoroscopic examinations of the entire human anatomy, gastrointestinal tract, full vascular/interventional capabilities, and organ examinations.

The Clinix mp is a remote controlled R/F X-ray system intended for radiographic/ fluoroscopic examinations of the entire human anatomy. This device may include signal analysis and display equipment, patient equipment supports, components and accessorial

The provided text describes a medical device, the Clinix mp, an R/F X-ray system. However, it does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The document is primarily a 510(k) summary and an FDA clearance letter, which focus on demonstrating substantial equivalence to a predicate device and confirming regulatory compliance rather than presenting detailed performance study results.

Therefore, I cannot fulfill your request for the specific information you asked for based on the text provided. The text only states:

• "Effectiveness is established by MECALL's evaluation throughout all phases of the Clinix mp development. The product will perform in accordance with the development specifications."

This is a general statement about internal evaluation and adherence to specifications, not a detailed report of a study with specific acceptance criteria and performance metrics.

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