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The Coalescent Surgical U-CLIP™ is intended for endoscopic and non-endoscopic use in tissue and prosthetic material approximation and the creation of anastomoses in blood vessels, grafts and other tubular structures; including cardiovascular and coronary artery bypass grafting procedures.

The Coalescent Surgical U-CLIP™ is a single self-closing clip for vascular anastomosis and tissue approximation applications. The U-CLIP consists of a specially designed vascular clip with a needle connected to one end via a flexible member. This design allows precise placement of clips prior to closure and facilitation of an interrupted technique. The device is fabricated from standard medical and implantable grade materials.

I am sorry, but the provided text does not contain the specific information required to complete the table and answer the questions asked about acceptance criteria and study details. The document is a 510(k) summary for a medical device (Coalescent Surgical U-CLIP™), which primarily focuses on establishing substantial equivalence to predicate devices, rather than detailing specific performance acceptance criteria and study results in the manner requested.

The document mentions "Clinical data confirm that functional characteristics are substantially equivalent to the predicate, and fall within, both, internal specification requirements, as well as device performance expectations," but it does not provide:

• A table of specific acceptance criteria.
• Reported device performance against those criteria.
• Sample sizes for test or training sets.
• Data provenance.
• Details about expert involvement, adjudication, or ground truth establishment.
• Information on MRMC studies or standalone algorithmic performance.

Therefore, I cannot fulfill your request based on the provided text.

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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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The Aortic Connector System is intended to create the aortic anastomosis of aortic autologous vein grafts.

The Aortic Connector System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent, and reproducible anastomosis. The Symmetry Aortic Connector System consists of a self expanding implantable connector and delivery system.

Here's a breakdown of the acceptance criteria and study information for the Aortic Connector System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes used for the mechanical, in vitro, or animal testing.

• Test Set Sample Size: Not specified.
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. Given the context of a 510(k) submission in the US, it's highly likely the testing was conducted in the US and involved a mix of in vitro (laboratory), mechanical (simulated conditions), and in vivo (animal) studies. The type of testing suggests it was prospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of human experts to establish ground truth for the device's performance. The testing described focuses on objective mechanical and biological endpoints rather than expert-derived assessments.

4. Adjudication Method for the Test Set

Not applicable, as expert adjudication is not mentioned in the testing described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study compares the device's performance to "standard suture anastomoses" through mechanical, in vitro, and animal testing, not against human readers' performance with and without AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described is effectively "standalone" in the sense that it evaluates the device's inherent mechanical and biological performance without human intervention in the loop for assessment. The "device" in this context is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the study was established through objective measurements and observations from mechanical, in vitro, and animal testing, comparing the Aortic Connector System's performance to "standard suture anastomoses." This would include metrics such as:

• Mechanical strength/integrity (e.g., burst pressure, tensile strength of the anastomosis)
• Patency (e.g., flow characteristics in in vitro models or animal studies)
• Biocompatibility and tissue response in animal models
• Reproducibility of the anastomosis

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here, as this device is a physical medical implant and delivery system, not an artificial intelligence/machine learning algorithm that requires training data.

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

Not applicable, as there is no training set for this device.

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