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Electrophysiology catheter accessory cables are intended for use during electrophysiology studies to connect an electrode catheter to recording/pacing equipment.

Vanguard reprocessed electrophysiology catheter accessory cables are accessories to an appropriate diagnostic catheter. The use of the cable provides a means of electrically connecting the EP catheter to recording/pacing equipment while allowing the catheter to remain in the sterile field and also provides additional working length.

Vanguard reprocessed accessory cables are constructed of a hollow polymer shaft approximately 4 to 7 feet in length that terminates with at each end with a connector. One connector couples with the proximal connector of an electrophysiology catheter; the other connector couples with an extension cable or an electrophysiology console. Various connector types are available at each end to match the appropriate electrophysiology catheter and console.

Vanguard receives previously used accessory cables from healthcare facilities and cleans, inspects, tests, applies a unique serial number, packages, labels, and sterilizes each device for return to the healthcare facility.

This document describes the acceptance criteria and the study that proves the device meets those criteria for the "Vanguard Reprocessed Electrophysiology (EP) Catheter Accessory Cable" (K030005).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to the concept of substantial equivalence to predicate devices. The study aims to demonstrate that the reprocessed device performs as intended and is safe and effective, similar to the original equipment manufacturer (OEM) devices and the listed predicate devices.

Summary of Study:

The study conducted to demonstrate that the Vanguard Reprocessed EP Catheter Accessory Cables meet the acceptance criteria is described as follows:

• Test Data Performed: "Cleaning, sterilization, and packaging validations and performance testing demonstrate that the reprocessed devices perform as intended and are safe and effective."

2. Sample size used for the test set and the data provenance:

• Sample Size: The document does not specify the exact sample size used for the cleaning, sterilization, packaging validations, and performance testing.
• Data Provenance: The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). However, given that Vanguard receives previously used cables from healthcare facilities for reprocessing, the data would inherently be derived from reprocessed devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not provided in the given text. The study primarily focuses on technical validations and performance testing rather than expert-based ground truth establishment for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• This information is not applicable and not provided in the given text. The type of study described (technical validations and performance testing) typically does not involve adjudication methods like those used in clinical or image-based diagnostic studies.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that are interpreted by human readers, often with AI assistance. The Vanguard device is a reprocessed accessory cable, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No, a standalone algorithm-only performance study was not done. The device is a physical electrophysiology catheter accessory cable, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this study is based on the engineering and performance specifications of the OEM devices and the regulatory standards for safety and effectiveness of medical devices, particularly for reprocessing.
  • For cleaning: Efficacy of cleaning procedures (e.g., reduction of bioburden, removal of contaminants).
  • For sterilization: Assurance of sterility (e.g., sterility assurance level (SAL)).
  • For packaging: Maintenance of sterility and physical integrity.
  • For performance: Electrical continuity, impedance, signal integrity, and mechanical integrity matching the OEM device specifications.

8. The sample size for the training set:

• This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning or AI models, which is not what this device is. The "training" for this device would refer to the processes and procedures for reprocessing, which are validated through the described testing.

9. How the ground truth for the training set was established:

• This information is not applicable and not provided for the same reasons as point 8. The "ground truth" for the reprocessing process (if we were to extend the concept) would be established by validated scientific and engineering principles for cleaning, sterilization, and material performance, as well as regulatory standards.

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