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ARIX Pectus Bar System is intended for use in surgical procedures to repair Pectus Excavatum and other anterior chest wall deformities.

ARIX Pectus Bar System is used in a minimally invasive surgical procedure to correct pectus excavatum, a type of deformity of the thoracic wall, characterized by a concave shaped chest.

This device consists of pectus bar and stabilizer to lift the sternum upwards to lessen the severity of the deformity.

ARIX Pectus Bar System includes appliance accessories used in surgical procedures to insert a fixation bar into the thoracic cavity and get it fixed to the coastal ribs for repairing pectus excavatum, a type of deformity of the thoracic wall.

Depending on the method of connection, Pectus Bars are used in combination of three types (Single Bar System, Double Bar System, Multi Bar System).

Especially, Single Bar System is used only for the Lower Bar, and the Upper Bar cannot be used alone.

I apologize, but the provided text is an FDA approval letter for a medical device called the "ARIX Pectus Bar System." This document primarily addresses the administrative aspects of the approval, including the regulatory classification, intended use, and comparison to predicate devices, to establish substantial equivalence.

It does not contain any information about acceptance criteria for a study, nor does it describe a study (clinical or non-clinical in detail) that proves the device meets specific performance criteria. The letter explicitly states:

• "No clinical studies were considered necessary and performed."
• It mentions "Bench tests were conducted to ensure the safety and effectiveness of the device as well as to demonstrate substantial equivalence to the predicate device" and lists some ASTM standards, but it does not provide any specific acceptance criteria or reported performance results from these tests.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The requested information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment for test/training sets, and training set sample size is not present in this document.

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