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

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, without assistance from a camera, endoscope, etc., or any other viewing technology. This includes procedures performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

The AtriClip LAA Exclusion System consists of a single use, sterile, self-closing, implantable PRO-V Clip preloaded on a Single Use Clip Applier. When closed, the PRO·V Clip applies uniform pressure over the length of the clip to ensure consistent, reproducible, and secure occlusion of the left atrial appendage (LAA). The PRO-V Clip is available in the following lengths to accommodate different sizes of LAA: 35 mm (PROV35), 40 mm (PROV40), 45 mm (PROV45), and 50 mm (PROV50).

The PRO·V Clip Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the PRO·V Clip.

I am sorry, but based on the provided document, I cannot answer the question as it pertains to acceptance criteria and the study that proves the device meets the acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device (AtriClip LAA Exclusion System), which describes the device, its indications for use, comparison to a predicate device, and various performance tests conducted. However, it does not contain specific acceptance criteria (e.g., target accuracy, sensitivity, specificity values) for statistical-based performance claims, nor does it detail a study proving the device meets particular acceptance criteria in the manner typically associated with clinical performance studies for diagnostic AI devices.

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, and the performance data section describes various non-clinical tests (animal study, mechanical, reliability, leak, corrosion, MR compatibility, biocompatibility) to show safety and performance, not statistical performance against predefined acceptance criteria for a diagnostic measure.

Therefore, the requested information, particularly the numbered points 1-9 directly related to acceptance criteria, sample sizes, ground truth, expert involvement, and MRMC studies, is not present in this document.

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