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SJM-Daig Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

The electrophysiology catheters are manufactured in various fixed and deflectable curve profiles and electrode spacings for electrophysiological mapping for the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

This 510(k) submission (K022380) for the St. Jude Medical, DAIG Division Livewire Electrophysiology Catheter does not contain acceptance criteria or a study proving the device meets specific performance criteria in the way a modern AI/ML device submission would.

Instead, this submission from 2002 relies on the concept of substantial equivalence to a predicate device. The performance data section explicitly states: "Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites." This indicates that the safety and effectiveness of the type of device (electrophysiology diagnostic catheters) were established by previously reviewed literature, and the current device is deemed substantially equivalent to a predicate.

Therefore, many of the requested categories for a contemporary AI/ML device study are not applicable here.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not applicable. No specific test set data is presented for this device. The submission relies on previously established safety and effectiveness of electrophysiology catheters as a class of devices, as cited in a previous submission (K002976).

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

• Not applicable. No specific test set with ground truth established by experts is described for this device in this submission.

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

• Not applicable. No test set or adjudication method is described.

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 device is a diagnostic electrophysiology catheter, not an AI/ML algorithm. There is no human-in-the-loop performance or AI assistance involved.

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

• Not applicable. This is a hardware device, not a standalone algorithm.

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

• Not applicable. No specific ground truth data is presented for this device. The safety and effectiveness are inferred from the class of devices and previous literature, likely based on clinical outcomes and expert understanding of cardiac electrophysiology from prior studies.

8. The sample size for the training set

• Not applicable. This is a hardware device, not an AI/ML algorithm that undergoes a "training" process with a dataset.

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

• Not applicable. No training set or ground truth establishment relevant to an AI/ML context is described.

Summary of the Study Proving Acceptance Criteria:

The "study" or justification for the Livewire Electrophysiology Catheter meeting its intended purpose is based on the substantial equivalence paradigm prevalent for 510(k) submissions. The submission states:

• "Related published literature was cited in K002976 to show Safety and Effectiveness of the use of electrophysiology diagnostic catheters to evaluate cardiac arrhythmias from endocardial and intravascular sites." (Section D)
• "All technological characteristics of the SJM-Daig Livewire Electrophysiology Catheters are substantially equivalent to the predicate SJM-Daig Electrophysiology Catheter including product design, materials, packaging, and sterilization." (Section C)

This means that the device is considered safe and effective because:

1. The general class of devices (diagnostic electrophysiology catheters) has established safety and effectiveness through previous studies and clinical use (referenced by K002976).
2. The Livewire Electrophysiology Catheter is technologically identical or very similar in design, materials, and function to a previously cleared predicate device, implying it will perform equivalently.

Therefore, no new clinical study specific to the Livewire device, with acceptance criteria and performance metrics, was required or presented in this 510(k) submission.

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