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This catheter is intended for temporary intracardiac pacing and recording during electrophysiology studies, e.g. evaluation of arrhythmias or cardiac mapping.

Reprocessed diagnostic electrophysiology catheters are constructed of a hollow polymer shaft approximately 92 to 125 cm in length that terminates with a hand piece or connector. A range of diameters is available; the most clinically utilized sizes are 5 – 7 French. Various configurations of distal platinum alloy electrodes are wired to a proximal connector for bi-directional transmission of electrical signals (pacing and recording). The connector is attached to an interconnecting cable that interfaces with various standard types of sensing, recording, stimulation and pacing equipment. The catheters are available with various distal curves, either fixed or steerable for remote manipulation of the distal tip segment that facilitates precise positioning of the electrode array.

The catheters are also available in a variety of electrode configurations, connector compatibility and torque-transmitting properties that are selected by the clinician based on preference and/or indication. The shaft polymer is manufactured with additives (typically barium sulfate) that enhance the catheter's radiopacity to enable positioning under fluoroscopic guidance. No lumens of catheters reprocessed by Vanguard are open to the patient bloodstream.

Vanguard collects previously used diagnostic EP catheters from healthcare facilities; cleans, inspects, tests, applies a unique serial number, packages, labels and sterilizes each device for return to the healthcare facility for an additional clinical use.

This document is a 510(k) summary for the Vanguard Reprocessed Diagnostic Electrophysiology (EP) Catheters. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on validation testing.

Here's an analysis of the acceptance criteria and study information:

Key Takeaway: This document does NOT describe the acceptance criteria and the study that proves the device meets them in the context of an AI/ML medical device. Instead, it details the regulatory submission for a reprocessed medical device (electrophysiology catheters), focusing on demonstrating that the reprocessed devices maintain the same safety and effectiveness as new devices.

Therefore, I cannot extract the requested information regarding AI/ML device performance, ground truth, expert adjudication, or MRMC studies from this document. The questions are designed for AI/ML device submissions, which this is not.

However, I can extract information relevant to the type of validation performed for this reprocessed device:

1. A table of acceptance criteria and the reported device performance

This document does not specify quantitative acceptance criteria in the format of an AI/ML performance table (e.g., sensitivity, specificity thresholds). Instead, the "acceptance criteria" are implicitly that the reprocessed device performs identically to the original equipment manufacturer (OEM) device and is safe and effective.

The reported "device performance" is:

The following numbered points cannot be answered from the provided text as they pertain to AI/ML device studies, which this document is not about.

2. Sample size used for the test set and the data provenance: Not applicable. This is for a reprocessed physical device, not an AI/ML algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML model is not relevant here. Device validation involves physical and biological testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI/ML context. For this device, "ground truth" would be established via physical, chemical, and biological tests to confirm the device's functionality, cleanliness, sterility, and material integrity compared to the new device specifications and regulatory standards.
8. The sample size for the training set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

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