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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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The SERPENTA™ Coronary Sinus Introducer System is intended for introducing balloon catheters into the coronary sinus or leads into vessels of the left heart via the coronary sinus. SERPENTA™ Coronary Sinus Introducer System is supplied sterile and intended for one time use

The Cook Vascular SERPENTA™ Coronary Sinus Introducer System consists of two Teflon (PTFE) introducer sheaths (7 Fr. and 10 Fr.) with varying shaped curves, two Teflon (PTFE) dilators (7 Fr. and 10 Fr.) two silicone Peel-Away introducer valves (D.C.# K010128), a hydrophilic coated guide wire with a torque handle, a 10cc plastic syringe and a stainless steel introducer needle. Some sets include a polyethylene obturator.

I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or a study that proves the device meets specific criteria for the Cook Vascular SERPENTA™ Coronary Sinus Introducer System. The document is a 510(k) premarket notification summary from the FDA, which primarily focuses on establishing substantial equivalence to predicate devices, device description, and indications for use.

Therefore, I cannot populate the table or answer the questions related to acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies based on the provided text.

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