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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 performed by sternotomy (full or partial) as well as thoracotomy (single or multiple).

The AtriClip PRO2 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 Applier is a disposable device with a handle, shaft, suture anchors, and deployment loop which contains the Clip. This Special 510(k) contains design modifications to the predicate AtriClip LAA Exclusion System (PRO1) intended to eliminate the End Effector Hoop configuration, allow for active articulation via articulation controls, and increase ease of deployment of the clip.

This appears to be a 510(k) summary for the AtriClip LAA Exclusion System with Preloaded Gillinov-Cosgrove Clip (PRO2). It's a submission for modifications to a previously cleared device (PRO1) and focuses on demonstrating equivalence rather than establishing new performance criteria against a disease or condition. Therefore, the traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in terms of clinical diagnostic performance are not directly applicable in this context.

Instead, the submission aims to demonstrate that the modified device (PRO2) is substantially equivalent to the predicate device (PRO1) and does not raise new questions of safety or effectiveness. The "acceptance criteria" here, implicitly, are that the modified device's performance is at least as good as, and within acceptable limits of, the predicate device across defined engineering and biocompatibility tests.

Here's an attempt to structure the information based on the provided request, interpreting "acceptance criteria" as the performance benchmarks for demonstrating substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes for the mechanical, reliability, animal model, or MR testing. It refers generally to "testing" being performed. Data provenance is not specified beyond "Non-clinical Bench Testing" and "Bench Testing on an Animal Model." This implies controlled laboratory and animal studies rather than human clinical data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable. This is not a study requiring expert consensus on diagnostic imaging or clinical outcomes. The "ground truth" for these engineering tests is established by physical measurements, material properties, and biological responses according to established standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication is typically used in clinical studies when there's ambiguity in classifying clinical endpoints or imaging findings. For engineering and biocompatibility tests, results are typically quantitative or directly observable against established pass/fail criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that assist human readers in tasks like interpreting medical images. The AtriClip is an implantable medical device, and the submission focuses on its physical and biological performance, not its interpretive assistance to clinicians.

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

This information is not applicable. This device is not an algorithm or AI system. It's a surgical implant and delivery system.

7. The Type of Ground Truth Used

For the non-clinical tests:

• Mechanical and Reliability Testing: The "ground truth" is defined by the physical and engineering specifications and performance characteristics of the predicate device (PRO1) and relevant industry standards.
• Magnetic Resonance Testing: The "ground truth" is adherence to the safety and compatibility requirements outlined in FDA Guidance (December 11, 2014) for passive implants in an MR environment.
• Biocompatibility Testing: The "ground truth" is established by the International Standard ISO 10993-1, which defines acceptable biological responses to medical devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" as this is not a machine learning or AI-based device. The development and design of the PRO2 were likely based on engineering principles, predicate device experience (PRO1), and iterative testing, not a formal training set for an algorithm.

9. How the Ground Truth for the Training Set was Established

This information is not applicable as there is no training set.

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