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Exprt™ Revision Hip System is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The EXPRT™ Revision Hip System includes non-porous distal femoral stem implants and nonporous proximal body implants, with bolt, all made from titanium alloy (Ti6Al4V) per ASTM F1472. System specific instrumentation allows the surgeon to prepare the bone to accept the EXPRT™ Revision Hip System implants.

This document is a 510(k) summary for the EXPRT™ Revision Hip System, a medical device. It does not describe an AI/ML medical device, and therefore the requested information regarding acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance metrics, is not present.

The document is a regulatory submission for a traditional medical device (a hip replacement system). The "acceptance criteria" and "study" mentioned here refer to the non-clinical and pre-clinical testing required for substantial equivalence, not performance metrics for an AI algorithm.

Here's a breakdown of why the requested information cannot be extracted from this document:

• No AI/ML Component: The device is a physical hip implant (EXPRT™ Revision Hip System). There is no mention of any AI or machine learning component.
• "Acceptance Criteria" Context: For a physical device like a hip implant, "acceptance criteria" typically relate to mechanical strength, biocompatibility, material properties, and manufacturing quality, not diagnostic performance or AI model accuracy.
• "Study" Context: The document mentions "Non-Clinical Testing: ROM testing and distal fatigue testing," and "Endotoxin Assessment," which are standard tests for orthopedic implants to determine their mechanical integrity and safety. It explicitly states, "Clinical Testing: Clinical testing was not required." This indicates that the substantial equivalence was based on non-clinical data comparing it to existing predicate devices.

Therefore, it is impossible to provide the requested information in the format specified because it pertains to an AI/ML context that is not applicable to this document.

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