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The IntraClude Intra-Aortic Occlusion Catheter is Indicated for use in patients undergoing cardiopulmonary bypass. The IntraClude Intra-Aortic Occlusion Catheter occludes and vents the ascending aorta when the balloon is inflated. The device's central lumen allows delivery of cardioplegia to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure.

The IntraClude Intra-Aortic Occlusion Device is a 10.5 Fr (3.5 mm), triple-lumen, 100cm-long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation during cardiopulmonary bypass (CPB). The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. This device is designed to be used in the femoral approach with the Edwards arterial cannula/introducer sheath. The shaft is provided with an extended strain relief, which tapers from 10.5 Fr to the remaining 9 Fr catheter, and is designed to prevent kinking and to avoid compressing the shaft when the hemostasis valve of an arterial cannula/introducer sheath is firmly closed around the catheter body. The large central lumen of the IntraClude catheter serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring. The hub has two flexible extension tubes with an integrated luer connection to provide access for accessories. The shaft is provided with markers to indicate the insertion depth. A blue Clamp-Lock device, provided on the extended strain relief portion, allows the IntraClude catheter to be locked in position to prevent balloon migration during aortic occlusion. For situations where the 9 Fr section of the device is outside of the arterial cannula or introducer sheath, a white suture loop/box clamp is provided for locking the catheter in position. The IntraClude catheter is packaged sterile and non-pyrogenic and is for single use only.

Here's an analysis of the provided text regarding the Edwards Lifesciences® IntraClude™ Intra-Aortic Occlusion Device, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify the sample sizes used for each individual test (e.g., number of catheters tested for tensile strength, kink resistance, etc.).

The data provenance is from benchtop in-vitro studies. There is no indication of human or animal subjects, or any country of origin for such data. All testing appears to be conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since all testing was functional and benchtop-based, the concept of "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes is not applicable here. The "ground truth" for these tests would be the predetermined engineering specifications and performance standards defined by the manufacturer and relevant regulatory guidelines (e.g., ISO 10993-1).

4. Adjudication Method for the Test Set

As the testing involves objective measurements against engineering specifications, an adjudication method in the sense of expert review or consensus (like 2+1 or 3+1) is not applicable. The outcome of each test is a direct measurement compared to a pre-defined range or threshold.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed, nor is it relevant for this type of device. This device is a medical instrument (catheter), not an imaging or diagnostic AI tool. Therefore, there's no "human readers," "AI assistance," or "effect size" in the context described for an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of an algorithm's performance without human-in-the-loop was not performed, nor is it relevant for this device. This is a physical medical device, not a software algorithm. The "performance" is its physical and mechanical attributes, not an algorithm's output.

7. Type of Ground Truth Used

The ground truth used for these studies was engineering specifications and performance standards. These would be based on:

• Industry standards (e.g., ISO 10993-1 for biocompatibility).
• Internal design requirements of Edwards Lifesciences for the device's functional integrity.
• Requirements derived from the predicate device's performance.

8. Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning algorithms. Since this device is a physical medical instrument and the studies described are benchtop functional and safety tests, there is no "training set" in the machine learning sense. The device's design and manufacturing processes are refined through engineering, prototyping, and testing, not by training an algorithm on a dataset.

9. How the Ground Truth for the Training Set Was Established

Given that there is no "training set" for a machine learning algorithm, this question is not applicable. The "ground truth" for the device's design and performance requirements would have been established through a combination of engineering design specifications, regulatory requirements, and historical data from similar devices.

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