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The Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

The Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology (EP) Catheters are radiopaque, flexible, insulated catheters with a polymer shaft. The catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, specifically, Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters. The core of a 510(k) submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This typically involves showing that the device has the same intended use and similar technological characteristics, or that any differences do not raise new questions of safety and effectiveness.

For a reprocessed device, the substantiation often focuses on demonstrating that the reprocessing does not compromise the device's safety and effectiveness compared to new devices or already reprocessed predicate devices. The "study" mentioned in this context is a series of bench and laboratory tests rather than a clinical study.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria with corresponding performance metrics like a standalone AI performance evaluation would. Instead, it lists the types of testing performed to demonstrate that the reprocessed devices are "as safe and effective as the predicate devices." The "reported device performance" is essentially that the device passed these tests, implying they met internal or established industry standards for reprocessed devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each of the listed functional and safety tests (e.g., how many reprocessed catheters were tested for biocompatibility, cleaning, or functional checks). It only states that "Bench and laboratory testing was conducted."

• Sample Size for Test Set: Not explicitly stated in the provided document.
• Data Provenance: The testing was conducted in a laboratory setting by Innovative Health, LLC. The data is thus prospective, generated specifically for this submission. The "country of origin" would be the US, where Innovative Health is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is typically relevant for studies involving human interpretation or clinical endpoints, such as medical imaging AI. For this reprocessed device, the "ground truth" is established through engineering and laboratory standards.

• No "experts" in the sense of clinical reviewers (e.g., radiologists) were used to establish a ground truth for a test set. The ground truth for functional and safety testing is based on established engineering specifications, material science, and regulatory standards for medical devices and reprocessing. The "observers" would be the engineers and technicians performing the tests.

4. Adjudication Method for the Test Set

Not applicable in this context. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human reviewers when establishing a clinical ground truth. For bench and laboratory testing, results are typically objective measurements against predefined specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance

Not applicable. This is not an AI-assisted diagnostic or therapeutic device. It is a reprocessed electrophysiology catheter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is not an algorithm, but a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device's performance is based on engineering specifications, material safety standards, and established regulatory requirements for medical device reprocessing. This includes demonstrating:

• That the device is biocompatible after reprocessing.
• That it can be effectively cleaned and sterilized.
• That its functional and mechanical characteristics (e.g., electrical continuity, steerability, dimensions) remain within acceptable limits, comparable to the original new device specification or predicate device.
• That electrical safety is maintained.

8. The Sample Size for the Training Set

Not applicable. There is no training set in the context of a reprocessed medical device's physical and functional testing. Training sets are relevant for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

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