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The AtriCure Isolator® Synergy™ Surgical Ablation System is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy Surgical Ablation System is comprised of the Ablation and Sensing Unit (ASU), AtriCure Switch Matrix (ASB), an AtriCure Isolator Synergy device, and a footswitch. The AtriCure Isolator Synergy device is a single-patient use, electrosurgical instrument designed for use only with the ASU.

The AtriCure Isolator Synergy clamp is used for cardiac tissue ablation. When activated, the ASU delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the AtriCure Isolator Synergy Clamp. The Operator controls the application of this RF energy by pressing the Footswitch.

All AtriCure Isolator Synerqy devices are configured as vascular clamps and feature clamping jaws of various lengths, curvatures and apertures; rounded jaw tips, and cables that plugs into the ASB switch matrix and ASU RF generator.

The AtriCure Isolator Synergy Clamps features two pairs of opposing dual electrodes, an in-line handle with syringetype grip handle/ actuation and button release mechanisms.

There is a Glidepath™ Tape Guide that is a single-patient use, detachable, surgical device the guidance of surgical instruments through soft tissue during general surgical procedures. The Guide is package with ISOLATOR devices that have the Attachment Tip.

The Glidepath Tape Instrument Guide is a single-patient use, surgical device designed to facilitate the guidance of surgical instruments through soft tissue during general surgical procedures.

The provided document is a 510(k) summary for the AtriCure Isolator® Synergy™ Surgical Ablation System, which describes modifications to an existing device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria for a new device's performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study designs (like MRMC or standalone) are not explicitly present in the provided text as it pertains to showing the device meets new acceptance criteria. Instead, the document discusses how the modified device meets the same requirements for safety and efficacy as the predicate device.

Here's an attempt to answer the questions based on the information available:

Acceptance Criteria and Device Performance Study for AtriCure Isolator® Synergy™ Surgical Ablation System (K211311)

The submission K211311 describes modifications to the AtriCure Isolator Synergy Clamps, specifically an alternate end effector design change to an overmold configuration. The core claim is that the modified device remains substantially equivalent to the predicate device (cleared per K110117) and meets the same requirements for safety and efficacy. Therefore, the "acceptance criteria" can be inferred as maintaining the performance characteristics of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set:

The document states, "Performance testing confirmed that the Isolator Synergy Clamps meets the same requirements for safety and efficacy as the predicate Isolator Synergy Clamp." It also mentions, "the previously submitted bench and animal data remain valid for the AtriCure Isolator Synergy clamps."

• Sample Size: Not explicitly stated for specific performance tests on the modified device. The testing conducted was to confirm the modified clamps meet the same requirements as the predicate device.
• Data Provenance: Not specified, but likely proprietary internal testing data given the nature of a 510(k) submission for device modification. The reference to "previously submitted bench and animal data" suggests a combination of laboratory and animal studies, which would be prospective in nature. Country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable. This is a technical device modification submission, not a study involving expert human reader interpretation of images or data to establish ground truth. The ground truth for performance characteristics (e.g., transmurality, lesion width) would be established through direct physical measurements during bench and animal testing.

4. Adjudication Method for Test Set:

Not applicable. The "test set" performance is evaluated against engineering and biological criteria (e.g., lesion characteristics, biocompatibility), not through human reader adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or screening devices where human reader performance is a key metric. This submission concerns a surgical ablation system.

6. Standalone (Algorithm Only) Performance:

Not applicable. The device is a physical electrosurgical instrument; it does not involve algorithms or AI that would have standalone performance in the context of this submission. The clamp itself has no software.

7. Type of Ground Truth Used:

The ground truth for the performance claims (e.g., transmurality, lesion width, biocompatibility) would be based on:

• Direct Physical and Biological Measurements: During bench testing and animal studies. For instance, lesion transmurality would be confirmed through histological analysis in animal models.
• Standardized Testing Protocols: Results from tests against ISO and IEC standards (e.g., ISO 10993 for biocompatibility) serve as the ground truth for those specific aspects.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. The clinical application and underlying technology (RF ablation) are well-established.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for an AI/ML algorithm.

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