Search Results

The Epicor Ablation 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.

The provided text is a 510(k) summary for the Epicor Ablation System, indicating that its changes were reviewed and found substantially equivalent to a previously marketed predicate device (K080292). Crucially, this document does not contain information on acceptance criteria for a device, nor does it detail a study that proves the device meets specific performance criteria. Instead, it focuses on demonstrating equivalence to another marketed device through non-clinical (bench and user) testing.

Therefore, I cannot provide the requested information in the specified format because the input document does not contain the details of acceptance criteria or a study proving those criteria are met for the Epicor Ablation System.

The summary states:

• "The changes made to the Epicor Ablation System underwent a battery of bench and user tests. Device validation testing was conducted in accordance with in-house procedures."
• "An evaluation of the device changes indicates that the devices are as safe and effective as the previously marketed device to which they are being compared and do not raise any new issues of safety and effectiveness."

These statements suggest that studies were performed, but the document does not elaborate on:

1. Specific acceptance criteria: What quantitative or qualitative metrics were used to determine "safe and effective" or "as safe and effective"?
2. Reported device performance: What were the results of these bench and user tests?
3. Sample sizes, data provenance, ground truth, experts, adjudication, MRMC studies, or standalone performance: None of this information regarding study design or results is present in the 510(k) summary.
4. Training set information: As this is a 510(k) for an updated physical device, not an AI/ML algorithm, the concepts of training sets and ground truth for training are not applicable in this context.

Ask a specific question about this device