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The Accin™ Bipolar Head components are intended to be implanted to replace a portion of the hip for:

• Fractures of the proximal femur; .
• . Non-unions of proximal femoral neck fractures;
• Aseptic necrosis of the femoral head; .
• Osteo-rheumatoid and post traumatic arthritis of the hip with minimal . distortion of the acetabulum; and
• . Salvage of failed total hip arthroplasty.

The device is only for use where sufficient sound bone to seat the prosthesis is present and for use with the Accin Hip System components.

The Accin™ Bipolar Head System consists of a cobalt chrome femoral head with a preassembled polyethylene insert and a snap ring that locks the head into the insert.

This document is a 510(k) premarket notification for a medical device (Accin™ Bipolar Head System) and does not describe a study involving artificial intelligence or machine learning. Therefore, it is impossible to extract the requested information regarding AI acceptance criteria, performance, ground truth, or study methodology from the provided text.

The document focuses on establishing substantial equivalence to a predicate device (Stelkast Bipolar Head System) based on material composition and intended use for a traditional medical implant. The determination of safety and effectiveness for this type of device is typically based on:

• Manufacturing standards: Adherence to established quality systems (e.g., ISO 13485).
• Biocompatibility testing: Ensuring the materials are safe for implantation.
• Mechanical testing: Demonstrating the device meets performance standards for strength, wear, and durability (though specific test results are not detailed in this summary).
• Clinical experience with the predicate device: The predicate device has a history of safe and effective use.

Without information on an AI-driven component or a study evaluating its performance, I cannot fulfill the request for details related to AI acceptance criteria and studies.

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