MODIFICATION TO CARDEON AEGIS CATHETER by CARDEON CORP.

The provided text is a 510(k) summary for the Cardeon Aegis Catheter. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a predicate device, not on presenting detailed acceptance criteria and a human-readability study as would be typical for AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available or applicable in this document. This document describes a traditional medical device (a catheter), not a software or AI/ML device, so the requested format does not align with the information provided.

However, I can extract the following based on the available text:

A table of acceptance criteria and the reported device performance: This information is not explicitly provided in the format of a table with specific performance metrics and acceptance criteria. The submission states that "Results of product testing demonstrated that the Aegis Catheter functions as safely and effectively as predicate devices." This is a general statement of performance rather than specific, quantifiable acceptance criteria.
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/not provided. The submission refers to "product testing," which included "biocompatibility, in vitro and/or in vivo performance." However, specific sample sizes, study methodologies (retrospective/prospective), or data provenance are not detailed as they would be for an AI/ML device's test set.
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/not provided. 'Ground truth' in the context of an AI/ML device typically refers to expert-labeled data. For a physical device like a catheter, performance is assessed through engineering tests and potentially animal or human clinical trials, where 'ground truth' doesn't fit the same paradigm.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not provided. This refers to consensus-building among experts for labeling data, which is not relevant for this type of device submission.
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: Not applicable/not provided. MRMC studies are specific to AI-assisted diagnostic or interpretive devices, which this catheter is not.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not provided. This refers to AI algorithm performance without human intervention, which is irrelevant for a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. As mentioned, the concept of 'ground truth' in this context doesn't align with AI/ML device evaluation. The assessment of this catheter's safety and effectiveness would rely on engineering specifications, biocompatibility testing results, and comparison to predicate devices' established safety and performance profiles.
The sample size for the training set: Not applicable/not provided. This device is not an AI/ML model, so there is no "training set."
How the ground truth for the training set was established: Not applicable/not provided.

Summary

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).