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The ByPass CorLink™ Aortic Anastomotic Device (CorLink™ AAD) is intended to be used in CABG procedures for creating a sutureless proximal anastomosis between the Aorta and a venous graft conduit.

This 510(k) notification describes a device intended for use in Coronary Artery Bypass Grafting procedures for creating a rapid sutureless proximal anastomosis between a grafted vessel and the aorta. The C-Punch device is intended for creating the aortotomy in which the implanted device will be deployed. The C-Punch device is equivalent to the Linear Punch already cleared as a component of the CorLink AAD (K011589) with respect to intended use, materials and performance of the aortotomy. The major difference between the two systems is the method by which the punch creates the aortotomy. The Linear Punch creates an aortotomy by insertion of the punch tip to the aortic wall and retraction of the punch tip against the cutting tube. The cut piece of the aortic wall is contained within the cutting tube. The C-Punch achieves the same aortotomy sizes and quality by insertion of a central needle and cutting/coring the tissue by rotating the punch device clockwise and counterclockwise. The cut piece of the aortic wall is contained within the cutting/coring tube.

The provided text is a 510(k) summary for the ByPass LTD, CorLinkTM Automated Anastomotic System. This document focuses on demonstrating substantial equivalence to a predicate device and does not contain detailed information about acceptance criteria or specific study results in the format requested.

The document states: "Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance." and "Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness." However, it does not elaborate on what "performance data" was gathered, what specific metrics were used, or what acceptance criteria were applied.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be inferred or explicitly stated based on the text provided:

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

• Cannot be provided definitively from the given text. The document only generally states that "performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance." It also mentions "same aortotomy sizes and quality" for the C-Punch compared to the Linear Punch, implying these are performance characteristics considered. No specific quantitative criteria or reported values are given.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Cannot be provided from the given text. The document mentions "performance testing" but does not specify the sample size or the nature/provenance of the data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not applicable / Cannot be provided from the given text. This 510(k) summary does not describe a study involving expert-established ground truth for a test set in the context of diagnostic performance. It focuses on the comparison of a new surgical device component (C-Punch) to an existing one (Linear Punch) based on its mechanical performance.

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

• Not applicable / Cannot be provided from the given text. As above, no such adjudication method is relevant or mentioned for the type of testing described.

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 study was not done. This document describes a surgical device, not an AI-based diagnostic tool that would involve human readers or AI assistance in interpretation.

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

• Not applicable. This device is a manual surgical tool (a punch), not an algorithm or an AI system.

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

• Inferable: The "ground truth" or comparative standard for the C-Punch's performance seems to be its ability to achieve "the same aortotomy sizes and quality" as the predicate Linear Punch. This would likely be assessed through direct measurement and visual inspection of the aortotomies created by the devices in a laboratory or ex-vivo setting.

8. The sample size for the training set

• Not applicable. This device is not an AI model requiring a training set.

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

• Not applicable. This device is not an AI model requiring a training set.

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