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The Freedom Inguinal Hernia Implant is intended to be implanted to reinforce soft tissues where weakness for open repair of inguinal hernias exist.

The Freedom Inguinal Hernia Implant is used to plug or patch a hernia opening. The entire implant is made from polypropylene. It is comprised of two polypropylene meshes and two small polypropylene rings. A multi looped shaped core fills the hernia opening while an underlay patch reinforces the defect and holds the implant in place. This underlay patch helps to prevent expulsion and rotation. Once the tissue defect is prepared, the implant is deployed into the defect area using the Delivery Device provided in the Freedom Inquinal Hernia Repair Kit. The Delivery Device serves to compact the implant and provide access to the defect opening to aid implantation. Once deployed, the tissue contracts around the implant, gripping it in place. Currently, the implants come in two different sizes; 25mm and 40mm with corresponding Delivery Devices to accommodate different size defects. The implant and delivery device are provided sterile for single patient use.

The provided text describes a 510(k) summary for the Freedom Inguinal Hernia Implant, focusing on its substantial equivalence to predicate devices. It does not contain information about acceptance criteria and the study that proves a device meets those criteria in the context of AI/ML performance metrics.

The document is a regulatory submission for a surgical mesh, which is a physical medical device, not a software-driven diagnostic or AI/ML product. The "Performance Data" section discusses:

• Biocompatibility testing: Previously conducted and applicable.
• Bench testing and in vivo simulated use experiments: Conducted in hernia simulators and fresh bovine meat.

These tests are designed to demonstrate the physical and material performance of the surgical mesh, ensuring it meets product specifications and intended use. They are not related to AI/ML performance metrics such as sensitivity, specificity, or AUC.

Therefore, I cannot extract the requested information (acceptance criteria, reported device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) because the document does not present an AI/ML device or its associated performance evaluation.

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