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The CardioOptics Augmentative Cardiac Optical Imaging System is intended to image and onical structures within the chambers of the heart and great vessels. The system is to be used in conjunction with fluoroscopic imaging.

The system is also indicated for accessing the coronary sinus for pacemaker lead implantation. The system includes visualization means to image anatomical structures to augment navigation into the coronary sinus.

The CardioOptics Augmentative Cardiac Optical Imaging System is composed of a single-use catheter, accessories, and an Image Acquisition System. The system incorporates infrared light (IR) technology to provide visualization through flowing blood. This submission modifies the indications for use originally cleared in 510(k) No. K050808 to include visualization of the cardiac chambers and great vessels.

I'm sorry, but based on the provided text, I cannot find the information needed to describe the acceptance criteria, the study that proves the device meets those criteria, or any of the detailed aspects like sample sizes, ground truth establishment, or MRMC studies.

The document is a 510(k) summary for the CardioOptics Augmentative Cardiac Optical Imaging System, primarily focused on its regulatory clearance. It identifies the device, its indications for use, and confirms that it was found substantially equivalent to predicate devices. However, it does not include performance data, detailed study designs, or acceptance criteria usually found in a clinical study report.

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