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The Reprocessed Inquiry Steerable Diagnostic Electrophysiology Catheters are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies. The catheters are commonly placed at the hight right atrium, right ventricular apex, and HIS bundle.

The Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheters are flexible, insulated catheters constructed of thermoplastic elastomer material and noble metal electrodes. The tip of the steerable catheters may be manipulated with the control mechanism located in the handle at the proximal end of the catheter.

This document is a 510(k) premarket notification for a reprocessed medical device, specifically the Reprocessed Inquiry Steerable Diagnostic Electrophysiology (EP) Catheter. It focuses on demonstrating substantial equivalence to predicate devices and detailing the reprocessing procedures and validation, rather than an AI/ML device or a comparative effectiveness study involving human readers.

Therefore, many of the requested categories for AI/ML device studies - such as sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, training set size, and ground truth for training set - are not applicable to this type of regulatory submission.

The document primarily describes the safety and functional testing performed to demonstrate that the reprocessed device performs as intended and is safe.

Here's the information available and a clear indication of what is not applicable:

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

Study that proves the device meets the acceptance criteria:

The study that proves the device meets the acceptance criteria is a series of bench and laboratory tests described under "Functional and Safety Testing." These tests were conducted to demonstrate the performance (safety and effectiveness) of the Reprocessed Inquiry Steerable Diagnostic EP Catheter.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not specified in this document. The testing describes procedures like "cleaning validation," "sterilization validation," and various "functional testing" aspects (visual, dimensional, electrical, simulated use, mechanical, electrical safety, packaging). These tests would involve specific numbers of reprocessed units, but the exact sample sizes are not provided in this summary.
• Data Provenance: Not applicable/not specified. This is a premarket notification for a reprocessed device, not a data-driven AI/ML study. The data arises from internal bench and laboratory testing conducted by Innovative Health, LLC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is not an AI/ML device and does not involve establishing ground truth from expert consensus on medical images or clinical data. The "ground truth" for this device's performance comes from engineering and quality control specifications and tests.

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

• Not applicable. This is not an AI/ML device and does not involve clinical data adjudication.

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 a conventional medical device (reprocessed catheter), not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device.

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

• Not applicable in the context of typical AI/ML ground truth. The "ground truth" for this device's performance is established by engineering specifications, validated test methods, and compliance with recognized standards for medical device safety and functionality (e.g., electrical safety standards, biocompatibility standards, cleaning efficacy standards). The control group for comparison is the original, new device and the predicate devices.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device and therefore does not have a training set.

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

• Not applicable. This is not an AI/ML device.

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