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Helios Dermal Scaffold is intended for the management of wounds that include:

• Partial- and full- thickness wounds
• Pressure, diabetic, and venous ulcers
• Partial thickness burns
• Surgical wounds – donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
• Trauma wounds – abrasions, lacerations and skin tears
• Tunneled/undermined wounds
• Draining wounds

Helios Dermal Scaffold is an acellular dermal tissue matrix derived from fetal bovine dermis. The single-use device is supplied sterile and is provided in sheet form in a variety of sizes and configurations, including meshed, solid, and fenestrated designs ranging from 1.5 - 500 cm² to be trimmed by the surgeon to meet the individual patient's needs.

The provided FDA 510(k) clearance letter for the Helios Dermal Scaffold does not contain any information regarding acceptance criteria or the study details typically associated with AI/ML device performance validation.

This document is for a medical device (a dermal scaffold), which is a biological product, not a software or AI/ML-driven diagnostic device. The performance data section refers to physical and biological characteristics of the scaffold, such as:

• Device Characterization Testing: Dimensional verification, color and appearance, suture retention strength, acellularity (histology), collagen denaturation.
• Design Validations: Viral inactivation, sterilization.
• Biocompatibility
• Shelf-life
• Packaging testing

These tests are standard for biological and implantable materials, ensuring their physical integrity, safety, and compatibility with the human body. They do not involve AI/ML algorithms, image analysis, or diagnostic accuracy.

Therefore, it is not possible to extract the requested information (acceptance criteria, sample size, ground truth, expert opinions, MRMC studies, etc.) from this document, as those concepts are not applicable to the type of device described.

To answer your prompt with the requested information, the input document would need to be a 510(k) clearance letter for an AI/ML medical device, typically referencing a clinical study or performance study that evaluates diagnostic accuracy, sensitivity, specificity, or reader agreement.

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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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CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is intended for pericardial reconstruction and repair and for epicardial support and repair.

CardiaMend™ Pericardial and Epicardial Reconstruction Matrix is a porous acellular matrix derived from fetal bovine dermis designed to provide soft tissue reinforcement, repair, and reconstruction. The single-layer (1 ply) device is not chemically crosslinked and consists of a naturally woven network of collagen fibers. The single use device is supplied terminally sterilized via ethylene oxide and is available in a variety of sizes to be trimmed by the physician to meet individual patient needs.

The provided text describes a 510(k) premarket notification for a medical device called CardiaMend™ Pericardial and Epicardial Reconstruction Matrix. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent safety and effectiveness through extensive clinical trials as an AI/ML medical device would typically require.

Therefore, the document does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm evaluation. Specifically, there is no mention of:

• Acceptance criteria in terms of AI/ML performance metrics (e.g., sensitivity, specificity, AUC).
• A "study that proves the device meets the acceptance criteria" in the context of AI/ML, such as a test set evaluation.
• Sample sizes for test sets or training sets, data provenance, ground truth establishment methods (expert consensus, pathology, outcomes data), number or qualifications of experts, adjudication methods, or MRMC comparative effectiveness studies.

The "Performance Data" section (Section VII) details various non-clinical tests performed to support substantial equivalence, including:

• Sterilization validation/re-qualification
• EO/ECH residuals per ISO 10993-7
• Packaging validation and shelf-life per ISO 11607-1 and ISO 11607-2
• Device Characterization Testing (Dimensional verification, Tensile Strength, Tensile Stiffness/Elastic Modulus, Burst Strength, Suture Pullout Strength, Cellular Infiltration, Porosity, Collagen Denaturation)
• Design Validations (Usability Validation)
• GLP Study in an Ovine Model (animal study evaluating performance and safety compared to a predicate device)

In summary, the provided document does not contain the information relevant to the performance evaluation of an AI/ML-based medical device as detailed in your request. It pertains to a Class II medical device (a collagen matrix) that uses a 510(k) pathway, which focuses on demonstrating substantial equivalence to existing devices through non-clinical performance data and an animal study, not AI/ML algorithm performance.

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