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Helios Dura Regeneration Matrix is indicated as a dura substitute for the repair of the dura mater.

Helios Dura Regeneration Matrix is a collagen implant for the repair of defects in the dura mater. The single-use device is supplied sterile in sheet form in a variety of sizes ranging from 6.5 - 250 cm² (~1 - 40-in²) to be trimmed and sutured or onlayed by the surgeon to meet the individual patient's needs.

The provided FDA 510(k) clearance letter and summary for the Helios Dura Regeneration Matrix do not contain the detailed information requested regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system. The document describes a medical device, specifically a dura substitute, and its equivalence to a predicate device. The performance data section refers to standard device characterization, design validation, biocompatibility, shelf-life, and packaging testing, which are typical for physical medical implants, not for AI-powered diagnostic or assistive technologies.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment as it pertains to an AI system.

Based on the provided text, the device is a physical dura substitute and not an AI/software device whose performance would be measured with the kind of criteria listed in your prompt.

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