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The AtriCure Isolator Synergy EnCapture Clamp is intended to ablate cardiac tissue during surgery.

The AtriCure Isolator Synergy EnCapture Clamp (referred to hereafter as CLAMP) is a single patient use electrosurgical instrument designed for use with an AtriCure RF GENERATOR. The CLAMP is used for cardiac tissue ablation. When activated, the GENERATOR delivers radiofrequency (RF) energy to the linear electrodes on the insulated jaws of the device. The Operator controls the application of this RF energy by pressing the Footswitch. The CLAMP features two pairs of opposing dual electrodes, an in-line handle with syringe-type actuation and button release mechanism. The device outer and ablative faces of the distal jaw segments have textured surfaces to increase the engagement between the jaw face and the cardiac tissue. The CLAMP is compatible with the Gidepath Tape Instrument (hereafter known as GUIDE), that is designed to attach to the fixed jaw of the CLAMP with a half turn attachment end connection. The GUIDE is a single-patient, optional component designed to facilitate the guidance of the CLAMP around target tissue during general surgical procedures.

The provided text describes a 510(k) premarket notification for the AtriCure Isolator Synergy EnCapture Ablation System (EMH). It primarily focuses on demonstrating substantial equivalence to a predicate device (Isolator Synergy Surgical Ablation System, K211311) rather than presenting a study proving a device meets specific acceptance criteria based on human expert performance in image analysis or similar tasks.

Therefore, many of the requested details about acceptance criteria for AI/image analysis devices, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training sets are not applicable to this document. This document details the clearance of a surgical ablation system, which is a physical device used to ablate cardiac tissue during surgery, not a software or AI-driven diagnostic/image analysis tool.

However, I can extract and present the relevant performance data and "acceptance criteria" (in the context of substantial equivalence) as described in the provided text.

Here's an analysis of the provided text in relation to your request:

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

Context: The device in question is the "AtriCure Isolator Synergy EnCapture Ablation System (EMH)," an electrosurgical instrument for cardiac tissue ablation. The regulatory submission is a 510(k), which aims to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to prove absolute performance against a predefined clinical metric as one might for a novel AI diagnostic. The "acceptance criteria" here therefore relate to demonstrating this substantial equivalence through various performance tests.

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

The document doesn't provide a direct table of "acceptance criteria" with numerical performance targets in the way one would for an AI diagnostic (e.g., AUC > 0.9). Instead, it presents various non-clinical and animal studies conducted to demonstrate that the new device performs "substantially equivalent" to its predicate. The acceptance for these tests is implicitly that the device performs comparably to the predicate and raises no new safety or effectiveness concerns.

2. Sample sized used for the test set and the data provenance:

• In Vivo GLP Animal Study: 12 pigs were used.
  • 6 pigs for the subject device (Isolator Synergy EnCapture Ablation System EMH).
  • 6 pigs for the predicate device (Isolator Synergy Surgical Ablation System EMR2/EML2).
• Data Provenance: The study was a GLP (Good Laboratory Practice) animal study. No information about country of origin, or retrospective/prospective human data is relevant as this is an animal study for a physical device.

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

• Not Applicable. This is a physical surgical device, not an AI/image analysis product requiring human expert interpretation for ground truth. The "ground truth" in the animal study would be the physiological and pathological outcomes measured directly from the animals (e.g., "conduction block" and "macroscopic and microscopic analysis").

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

• Not Applicable. As per point 3.

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. No MRMC study was performed because the device does not involve human readers interpreting cases/images.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:

• For the In Vivo GLP Animal Study: The ground truth was based on direct physiological outcomes (evidence of conduction block) and histopathology (macroscopic and microscopic analysis of tissue) post-ablation from the animal subjects. For the other tests (mechanical, biocompatibility, electrical safety), the "ground truth" is adherence to established engineering and safety standards.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI algorithm. There is no concept of a "training set" in the context of this regulatory submission.

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

• Not Applicable. As per point 8.

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