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Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.

Heartport Endosinus Catheter, Common Name: Sinus Catheter, Classification Name: Cardiopulmonary bypass vascular catheter

This document is a 510(k) summary for a medical device (Heartport Endosinus Catheter) and does not contain information about acceptance criteria for an AI/ML powered device, nor does it describe a study proving the device meets such criteria.

The 510(k) summary primarily focuses on:

• Device Identification: Trade name, common name, classification, and applicant information.
• Intended Use: Occlusion of the coronary sinus, delivery of cardioplegia, and monitoring of coronary sinus pressure during cardiopulmonary bypass.
• Predicate Devices: Comparison to existing devices for substantial equivalence.
• Non-clinical Test Results: A very high-level statement that "Performance testing has demonstrated with 95% confidence that the Endosinus Catheter will meet or exceed Heartport's performance standards."
• Test Conclusions: A general statement about safety and efficacy based on performance testing.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies because this document pertains to a traditional medical device submission and does not involve AI/ML technology or corresponding evaluation methodologies.

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