Search Results

The CorLink AAS is indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting (CABG). The Coring punch component penetrates the aorta and cuts a circumferential aortotomy in which the implanted device will be deployed.

This 510(k) notification describes the CorLink™ Automated Anastomotic Device indicated for creation of an anastomosis between a venous graft conduit and the aorta for coronary artery bypass grafting. The Coring punch device is intended for creating the aortotomy in which the implanted device will be deployed. The major differences between the two systems are: 1. The Piercing Tip and the Tissue Grabber are in one piece in the modified coring punch 2. Tissue Grabber button was replaced by an automatic Tissue Grabber activation button component 3. The Tissue Grabber in the modified coring punch contains 3 barbs instead of 2 as in the 510k cleared coring punch design 4. The Cylinder Cutting Edge diameter will range from 2.5 mm to 3.6 mm and from 2.9 mm to 4.0 mm in the 2.0 mm and 4.0 mm size kits (in 0.1 mm increments each), respectively. 5. The modified coring punch is single use only, whereas the 510(k) cleared coring punch was for single patient use.

This 510(k) summary does not contain information typically found in a clinical study report or a detailed validation study. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on modifications to a component. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present.

However, based on the provided text, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list quantitative "acceptance criteria" for the modified device's performance in the typical sense (e.g., a specific percentage success rate or a measurement tolerance). Instead, the criterion for acceptance is substantial equivalence to the predicate device in terms of performance, intended use, and technological characteristics.

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

• Sample Size: Not specified. The document mentions "performance testing" and "performance data gathered" but does not give specific numbers of tests or samples.
• Data Provenance: Not explicitly stated. The company is ByPass LTD, located in Herzelia B, Israel. The testing would presumably have been conducted by the manufacturer or a contract lab. Whether this was retrospective or prospective (in terms of design changes vs. new testing) isn't detailed, but the "performance testing provided in the application" suggests specific tests were conducted for this submission.

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

• This information is not provided in the 510(k) summary. The nature of the device (a surgical tool for creating an aortotomy) suggests "ground truth" would be established through direct observation of the punch's function and the resulting aortotomy in a controlled environment (e.g., animal models, cadaveric studies, or bench testing on tissue models), rather than through expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials or diagnostic studies where multiple readers interpret data. This is a device modification submission focused on mechanical function/performance.

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. This is not an AI-assisted diagnostic device, and thus, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

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

• Not applicable. This is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used

• The document implies that the ground truth for "performance testing" would relate to the successful creation of the aortotomy, its size, minimal tissue trauma, and integration with the implanted device. This would likely be assessed through direct physical measurement and visual inspection (e.g., histology, dimensional analysis) of the results of the punch's action on tissue. The text mentions the diameter range for the cutting edge, suggesting precise dimensional requirements.

8. The Sample Size for the Training Set

• Not applicable. This is a modification to a physical device, not a machine learning algorithm that requires a "training set."

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

• Not applicable, as there is no "training set" in the context of an AI algorithm. For the initial design and iteration of the device, engineering specifications and testing would have guided its development.

Ask a specific question about this device