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The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.

The St. Jude Medical Epicardial Catheter System consists of the ResponseTM 6 French quadripolar electrophysiology catheter and the AgilisTM NxT 40 cm steerable guiding introducer (which includes a dilator, guidewire and steerable sheath). The Agilis NxT Steerable Introducer provides pericardial access for the Response catheter to perform electrophysiology studies of the epicardial surface of the heart.

The provided text is a 510(k) summary for the St. Jude Medical Epicardial Catheter System, seeking clearance for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than presenting a performance study with detailed acceptance criteria for a novel AI/software device.

Consequently, much of the requested information (acceptance criteria table, sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, standalone performance, and training set details) is not present in the provided text. This document is a regulatory submission for a physical medical device (catheter system) and not an AI or software as a medical device (SaMD) that would typically undergo the types of studies you are asking about.

Therefore, I cannot fulfill your request for that specific information based on the provided input. The document does not describe a study that proves the device meets specific performance acceptance criteria in the way you've outlined for an AI/software product.

Here's an explanation of why the requested information is absent and what is present:

What the document does provide:

• Device Description: The St. Jude Medical Epicardial Catheter System consists of the Response™ 6 French quadripolar electrophysiology catheter and the Agilis™ NxT 40 cm steerable guiding introducer.
• Intended Use: "The St. Jude Medical Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart."
• Predicate Devices: Response™ Electrophysiology Catheter and Agilis™ NxT Steerable Introducer.
• Comparison to Predicate Devices: The submission claims substantial equivalence based on similar intended use and fundamental scientific technology, including packaging, biocompatibility, sterilization, and labeling. It states that "Where differences exist between the proposed devices and the predicate devices, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed devices."
• Regulatory Conclusion: St. Jude Medical considers the Epicardial Catheter System to be equivalent to the predicate devices based on similarities in design, technological characteristics, principles of operation, materials, and indications for use.

Why the requested information for AI/software studies is not available in this document:

1. Nature of the Device: The St. Jude Medical Epicardial Catheter System is a physical medical device (catheter and introducer) used for electrophysiology studies. It's not an AI/software device.
2. Regulatory Pathway: This is a 510(k) premarket notification, a pathway for demonstrating substantial equivalence to a legally marketed predicate device. This pathway typically focuses on comparing the new device's features, materials, and intended use to existing devices, and ensuring any differences do not raise new questions of safety or effectiveness. It does not generally require the detailed clinical performance studies, statistical analyses, or ground truth establishment that are common for novel AI/SaMD products or devices seeking de novo classification or PMA approval.
3. "Performance Testing" vs. "Clinical Study": While the document mentions "performance testing demonstrated that these differences do not adversely affect the safety and effectiveness," this likely refers to engineering, bench, or pre-clinical (e.g., animal model) testing to confirm mechanical properties, biocompatibility, and functionality, not a human clinical study with the kind of metrics you're requesting for an AI algorithm.

In summary, the provided document does not contain the information required to populate your table or answer the specific questions related to AI/software device studies.

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