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The AtriClip LAA Exclusion System is indicated for the occlusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or other appropriate viewing technologies.

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a Single Use Clip Applier along with a selection guide. When closed, the Clip applies uniform pressure over the length of the Clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The clip is then deployed and is left as a permanent implant. The Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm, 40 mm, 45 mm, and 50 mm.

The Clip Appliers are disposable devices with a handle, shaft, suture anchors, and deployment end-effector containing the Clip.

Here's a breakdown of the acceptance criteria and study information for the AtriClip LAA Exclusion System based on the provided document:

Acceptance Criteria and Device Performance

The document does not explicitly state formal "acceptance criteria" as a pass/fail threshold. Instead, it presents performance results from clinical studies and a published literature review, which serve as evidence of the device's safety and effectiveness. The "reported device performance" in the table below is derived from these stated clinical outcomes.

Study Information

The information provided describes a combination of clinical study data and a published literature review.

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

• Total Patients Evaluated (Clinical Evidence): 129 patients
• LAA occlusion directly following Clip deployment: 129 patients
• LAA exclusion post-operatively (3-12 months): 58 patients
• Data Provenance: The document emphasizes "clinical evidence based on the multiple IDE clinical studies and published clinical literature." This suggests a combination of prospective data from AtriCure-sponsored IDE studies (e.g., IDE Stroke, Hybrid DEEP, Staged DEEP) and data from retrospective or prospective studies included in the literature review. The country of origin is not specified but is implicitly the US for the IDE studies.

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

• This information is not provided in the document. The studies refer to "LAA occlusion" and "LAA exclusion" as outcomes, but do not specify how these were determined (e.g., by human experts, imaging interpretation, etc.) nor the qualifications of those involved in assessing these outcomes.

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

• This information is not provided in the document.

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 done. The device being reviewed is an implantable clip, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.

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

• Not applicable. The AtriClip LAA Exclusion System is a medical device (an implantable clip and applier), not an algorithm or AI system. Its performance is evaluated through its physical function in occluding the LAA in vivo.

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

• The ground truth appears to be based on clinical outcomes data from the clinical studies. For "LAA occlusion directly following Clip deployment," this would likely be immediate intraoperative assessment (visual or imaging). For "LAA exclusion post-operatively," this would typically involve follow-up imaging (e.g., transesophageal echocardiography) to confirm the complete closure or exclusion of the LAA.

8. The sample size for the training set:

• This information is not applicable/not provided as the device is not an AI/ML model that requires a training set in the conventional sense. The "training" for such a device would be its design, manufacturing, and preclinical testing phases.

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

• This information is not applicable/not provided for the same reason as above.

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