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Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.

The Temporary Cardiac Pacing Wire is a sterile single-use product. Temporary cardiac pacing wires consist of the following configurations and optional accessories:

1. The monopolar leads consist of one insulated multifilament stainless steel conductor coated with colored polyethylene.
2. The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle.
3. The exposed, uninsulated section of the intracorporeal end of the wire is either straight or has one or more multiple pre-formed curves (pre-formed wave).
4. The extracorporeal end of wire has a straight needle with breakaway tip attached.
5. The wire length is 60 cm.
6. Wires range in multiple diameters from 0 to 2-0, depending on the product code.

The provided text is a 510(k) Premarket Notification summary for a medical device called "Temporary Cardiac Pacing Wire." It describes the device, its intended use, and compares it to a predicate device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed device rather than proving the device meets a set of acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically for an AI/algorithm-based device. The device in this document is a physical medical device (cardiac pacing wire), and the "performance modification" mentioned refers to testing its compatibility with an MRI environment, not a software algorithm's performance.

To answer your request, if this were an AI/algorithm-based device, the document would need to outline the specific performance metrics (e.g., sensitivity, specificity, accuracy), the thresholds for those metrics (acceptance criteria), and details of a clinical or performance study (e.g., test set size, expert ground truth establishment, MRMC studies) to demonstrate that the algorithm met those criteria.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment for an AI/algorithm. The document focuses on showing substantial equivalence of a physical device with a predicate through design and material comparisons, and non-clinical performance testing related to MRI compatibility.

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