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The Epicor Medical Ablation Control System is intended for the ablation of cardiac tissue during cardiac surgery
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The UltraWand LP is intended for the ablation of cardiac tissue during cardiac surgery
The items in LP PAS System are part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
The LP Oblique Introducer is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery
The LP Connecting Cable is part of the Epicor Cardiac Ablation System. The System is intended for the ablation of cardiac tissue during cardiac surgery

The Epicor Ablation System is designed to deliver ultrasound energy to tissue in order to create an ablation lesion. Specifically, the system is intended for the ablation of cardiac tissue during cardiac surgery. The Ablation System consists of the Ablation Control System instrument, a reusable connecting cable, a family of sterile, disposable ablation devices, and accessories.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Epicor™ Ablation System:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria (e.g., a target accuracy or lesion size) and their corresponding reported device performance metrics are not explicitly stated. The document primarily focuses on establishing substantial equivalence to a predicate device through technological characteristics and non-clinical performance data.

Instead, the "acceptance criteria" can be inferred as demonstration of safety and effectiveness equivalent to the predicate device and that the changes do not raise any new issues of safety and effectiveness. The reported performance is that the device met these inferred criteria.

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

• Sample Size for Test Set: The document states that "a battery of bench and user tests" were conducted. However, the sample size for these tests is not specified.
• Data Provenance: The data comes from non-clinical (bench and user) tests conducted by St. Jude Medical ("in-house procedures"). There is no mention of clinical data, country of origin, or whether it was retrospective or prospective in the context of this 510(k) summary.

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

This information is not provided in the document. The document refers to "user tests," suggesting involvement of users (likely medical professionals), but details on their number or qualifications for establishing specific ground truth are absent.

4. Adjudication Method for the Test Set

The adjudication method is not described in the provided text. The document refers to "in-house procedures" for validation, but specific details on how disagreements or ambiguous results were resolved are not given.

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 conducted or reported in this 510(k) summary. This document pertains to a medical device for ultrasound energy delivery and ablation, not an AI or imaging-based diagnostic tool that would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable to the Epicor Ablation System as described. This is a procedural device that physically ablates tissue, not an algorithm, and does not have a "standalone" algorithmic performance in the typical sense of AI/image analysis. Its performance is tied to its physical interaction with tissue and control system.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical performance data would be based on the physical outcomes of the bench and user tests. This would likely include:

• Direct measurements of ablation lesion characteristics (e.g., size, depth, contiguity) in tissue samples (ex-vivo or in-vivo animal models, though the document doesn't specify in-vivo).
• Functional tests of the device's ability to deliver energy, maintain temperature, and operate within specifications.
• User feedback regarding ease of use and functionality.

It is not expert consensus, pathology (in the clinical diagnosis sense), or outcomes data from human patients, as this is a non-clinical submission for substantial equivalence.

8. The Sample Size for the Training Set

There is no mention of a training set in this document. This submission is for a medical device (ablation system), not an AI or machine learning algorithm that typically requires distinct training and test sets.

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

As there is no mention of a training set, this question is not applicable.

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