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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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The CardioOptics Coronary Sinus Access (CSA™) System is intended to provide subclavian access to the right heart for accessing the coronary sinus and placing a quide sheath suitable for pacemaker lead implantation into the coronary sinus. The system includes visualization means to image anatomical structures to augment navigation.

The Coronary Sinus Access (CSA™) System provides a catheter and sheath system for providing percutaneous access to the coronary sinus. In addition, the catheter provides visualization to augment the user's ability to locate the coronary sinus for placement of a guide sheath. The system includes a sterile, single use Coronary Sinus Access Kit, which includes a deflecting tip catheter with visualization capability (FLAIR™ CS Catheter), a Guide Sheath Set including a dilator and sheath slitters, and a Sterile Sleeve to drape over the camera pod. The system also includes an Imaging Acquisition System to collect and display video images present in front of the catheter tip.

The CardioOptics Coronary Sinus Access (CSA™) System underwent performance testing, including mechanical, functional, and animal studies, to establish substantial equivalence to predicate devices. Biocompatibility testing was also conducted.

Here is a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding device performance metrics. Instead, it states that various tests were performed to support "substantial equivalence" to predicate devices.

2. Sample Size and Data Provenance for Test Set

• Sample Size for Test Set: The document does not specify the sample sizes used for the mechanical, functional, or animal testing.
• Data Provenance: The provenance of the data (e.g., country of origin, retrospective or prospective) is not explicitly stated. Animal testing implies prospective data collection in a controlled environment.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the document. The device's performance is described in terms of "substantial equivalence" to predicate devices and meeting general testing requirements, rather than an evaluation against human expert-defined ground truth in a clinical setting.

4. Adjudication Method for Test Set

This information is not provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence through device testing.

6. Standalone Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not explicitly described or conducted, as the device is a system with visualization to augment human navigation rather than an autonomous algorithm. The visualization aspect of the FLAIR™ CS Catheter was shown to be substantially equivalent to angioscopes and associated video display systems.

7. Type of Ground Truth Used

The ground truth used for assessing the device's performance appears to be established through:

• Engineering and pre-clinical testing standards: Mechanical and functional performance would be measured against predefined specifications or engineering benchmarks.
• Biocompatibility standards: ISO 10993 serves as the ground truth framework for biocompatibility.
• Comparison to predicate devices: The concept of "substantial equivalence" implies that the device's performance or characteristics are compared to those of already legally marketed predicate devices, which serve as a de facto "ground truth" for regulatory clearance.
• Animal models: Animal testing provides a physiological environment to assess aspects like access and visualization, where observations by skilled operators in the animal model would serve as the ground truth.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI, as the device is not described as an AI/ML product. The testing performed relates to the physical and functional aspects of the medical device.

9. How Ground Truth for the Training Set was Established

As there is no mention of a training set for an AI/ML component, this information is not applicable.

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