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SurgiPure® XD Reconstructive Tissue Matrix is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or buttressing material to obtain the desired surgical outcome. The device is intended for single use (single patient one-time use) only.

SurgiPure™ XD Reconstructive Tissue Matrix is a surgical mesh made from porcine dermis which then undergoes a decellularisation process. The collagen matrix is subsequently packed into a double pouch and then sterillsed by irradiation. SurgiPure™ XD acts as a surgical mesh for soft tissue repair to provide a scaffold to the patient to allow cellular infiltration, neovascularisation and collagen deposition.

This document is a 510(K) summary for a medical device called "SurgiPure™ XD Reconstructive Tissue Matrix." It does not contain information about an AI/ML device or a study comparing its performance against acceptance criteria in the way described in the prompt. The performance data section refers to "extensive biocompatibility testing, animal testing, viral inactivation testing and biomechanical testing" for a surgical mesh, not an AI/ML diagnostic or predictive device.

Therefore, I cannot extract the requested information to fill in the table and answer the questions related to acceptance criteria and device performance for an AI/ML study.

The document covers:

• Device Name: SurgiPure™ XD Reconstructive Tissue Matrix
• Intended Use: As a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes, including the repair of hernias and/or body wall defects.
• Technological Characteristics: Surgical mesh made from porcine dermis, decellularized, packed into a double pouch, and sterilized by irradiation.
• Performance Data (for a physical mesh): Biocompatibility testing, animal testing, viral inactivation testing, and biomechanical testing. These tests ensure the material itself is safe and performs its function as a scaffold for tissue repair.
• Predicate Device: LTM Surgical Mesh (LifeCell Corporation, K070560)
• Conclusion: The device is substantially equivalent to the predicate device.

To answer the prompt, I would need a document describing the evaluation of an AI/ML-driven medical device, including a study protocol and results for its performance.

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