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The Reprocessed Electrophysiology Diagnostic Catheters are intended for temporary use during electrophysiology studies for intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias; and for electrophysiologic mapping of cardiac structures during these evaluations.

The device consists of a reprocessed catheter that has a high-torque shaft with a handle at the proximal end, and may or may not be steerable. These catheters have an outer diameter of 4F to 8F, a length ranging from 60 to 160 cm, with 2-20 platinum, radiopaque electrodes along the tip shaft and a variety of inter-electrode spacings and curve styles at the tip. The tip generally is deflectable. Specific cables, as recommended by the original manufacturer, connect to the handle and interface between the catheter and an external stimulator and/or an electrophysiologic recorder. It should be noted that this submission pertains to the catheter only. It does not include any other components in a system such as, connector cables, external stimulators, or electrophysiologic recorders.

This is not an AI/ML device, and therefore the criteria listed in parts 1-9 do not apply. This is a reprocessed medical device (electrophysiology diagnostic catheters) that functions identically to original manufacturer devices. The 510(k) summary focuses on demonstrating that the reprocessed device is substantially equivalent to predicate devices in terms of functional design, materials, indications for use, and construction.

Here's an analysis of the provided text, addressing the requested information where applicable for a non-AI/ML device:

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

For this reprocessed device, the "acceptance criteria" are essentially demonstrating substantial equivalence to the original, predicate devices. The performance is measured against these established characteristics rather than novel AI/ML metrics.

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

The document does not specify a "test set" in the context of an AI/ML model. Instead, it refers to "Representative samples of reprocessed electrophysiology diagnostic catheters" used for design testing. The sample size is not quantified.

• Sample Size: Not specified beyond "Representative samples."
• Data Provenance: Not explicitly stated, however, the testing would be conducted internally by SterilMed, Inc. (Minneapolis, MN, USA) on their reprocessed devices. This would be prospective for the reprocessed devices.

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)

This is not applicable to this type of device. "Ground truth" in the context of this device would refer to the established performance characteristics and safety profiles of the original predicate devices, as well as the successful validation of reprocessing steps (cleaning, sterilization). These are typically established through engineering standards, clinical trials of the original devices, and scientific validation methods, not expert consensus on interpretations like in AI/ML.

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

Not applicable. Adjudication is a term relevant to resolving discrepancies in expert interpretations, typically in AI/ML or clinical trial settings where subjective assessment is involved. The testing described for this device (functional and safety) involves objective measurements and validation protocols.

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-assisted diagnostic device, and therefore MRMC studies are irrelevant.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this reprocessed device is established by:

• Predicate Device Specifications: The known functional, material, and performance specifications of the original, legally marketed electrophysiology diagnostic catheters.
• Engineering Standards & Bench Testing: Objective measurements and tests (e.g., electrical conductivity, mechanical integrity, sterility assays) to ensure the reprocessed device meets these predefined specifications.
• Process Validation: Scientific evidence that the cleaning, sterilization, and packaging processes consistently achieve their intended outcomes without degrading the device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" for this device.

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