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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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The ByPass CorLink™ Anastomotic Device is intended to create vascular anastomoses between blood vessels. Specifically, the device is indicated for creation of a sutureless proximal anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG) procedures.

The ByPass CorLinkTM Automated Anastomotic Device (CorLinkTMAAD) intended use is to create the proximal graft-aorta anastomosis during a CABG procedure.

The CorLinkTM AAD, delivered with an introducer kit, is a single use system. The implant is made of self-expanding nitinol and composed of two main elements: the self-expandable center area and the flexible pins at both ends.

The center is made of connected elliptic arches, which upon implant expansion exert a radial force on the everted vein end and the aortic wall. The flexible pins from both ends of the device fold and "bite" the aortic wall in a way that connects and compresses the grafted vessel against the aorta. This procedure stabilizes the implant at the desired location and creates a sealing surface around the anastomosis.

This document describes a 510(k) premarket notification for the ByPass CorLink™ Automated Anastomotic Device (AAD). The information provided focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria and detailed study results for the device itself. Therefore, many of the requested details about acceptance criteria, specific performance metrics, and study design are not explicitly available in the provided text.

Based on the available information, here's what can be extracted and what remains unknown:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document states "Bench and animal testing" but does not provide numbers for either.
• Data Provenance: Not specified. The submission is from ByPass Ltd. in Herzelia, Israel, but the location of the animal testing and bench testing is not mentioned. The document does not specify if the data is retrospective or prospective.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: No, this is not an AI-assisted device and therefore an MRMC study is not applicable. The device is a physical medical implant/instrument for surgical procedures.

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

• Standalone Performance: Not applicable. This is a physical medical device, not an algorithm. Bench testing and animal testing were performed, which can be considered "standalone" in the sense of evaluating the device's physical performance independently, but not in the context of an AI algorithm.

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

• Type of Ground Truth: For the "bench and animal testing" to demonstrate safety and effectiveness, the ground truth would likely involve:
  • Bench Testing: Engineering measurements, force testing, leak testing, material properties analysis, etc.
  • Animal Testing: Surgical outcomes, histopathology of anastomotic sites, patency rates, observation of adverse events, etc.
  • The document does not detail specific metrics or the "ground truth" definition for the equivalence to predicate devices, beyond demonstrating comparable safety and effectiveness.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is not a machine learning or AI device. The concept of a "training set" as understood in AI is not relevant here.

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

• Ground Truth for Training Set: Not applicable (see point 8).

Summary of what is known and unknown:

• Known: The device is the ByPass CorLink™ Automated Anastomotic Device (AAD) for creating sutureless proximal anastomoses in CABG procedures. It's an implantable clip. Bench and animal testing were conducted to demonstrate biocompatibility, safety, effectiveness, and substantial equivalence to three predicate devices (USSC One-Shot Sutureless System, USSC Auto Suture Vascular Anastomosis Clip, and Deknatel Gwathmey Vascular Stapling Kit).
• Unknown: Specific numerical acceptance criteria, detailed results from bench and animal testing (e.g., number of animals, specific outcomes measured, statistical results), sample sizes for testing, exact methodologies for establishing safety/effectiveness beyond the general statement, and any information regarding expert involvement in ground truth determination.

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