(91 days)
The FoamSeal Retrograde Cardioplegia Catheter is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction.
The proposed modified FoamSeal Retrograde Cardioplegia Catheter is identical to the original FoamSeal Retrograde Cardioplegia Catheter (marketed under 510(k) # K941916), with the exception of a more rigid guide stylet.
The provided text is a 510(k) summary for the FoamSeal Retrograde Cardioplegia Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria in the context of a machine learning or AI-powered medical device.
The document describes a physical device, a catheter, and the "study" mentioned is a mechanical engineering test to compare the rigidity of a stylet. It's a non-clinical, bench-top test of a physical characteristic, not a clinical study or a performance evaluation of a device with "acceptance criteria" in the way that would apply to an AI system.
Therefore, I cannot fulfill your request for the specific information points as they relate to AI/ML device performance. The information you're asking for (sample size, data provenance, experts, adjudication, MRMC, standalone performance, ground truth, training set size) is relevant to AI/ML device validation, which is not what this 510(k) describes.
The document states:
- Study: "Stylet guide collapse testing was performed on the stylet guide from the proposed modified FoamSeal Retrograde Cardioplegia Catheter, and was compared to collapse values from the stylet guide used in the Research Medical retrograde cardioplegia catheter..."
- Purpose of Study: "The purpose of this test was to evaluate the force that can be generated by the stylet before buckling occurs, thereby providing a means for comparing stylet rigidity."
- Outcome/Finding: "Test results demonstrate that the modified FoamSeal Retrograde Cardioplegia Catheter stylet is less rigid than the Research Medical stylet, thereby presenting less of a potential for damage to the coronary sinus."
This is a physical test result, not an AI/ML performance metric.
§ 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).