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The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is indicated for the assessment of a patient's hemodynamic condition through direct intracardiac and pulmonary artery pressure monitoring. Secondary indications are for sampling blood and infusing solutions.

The Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material is used to monitor right heart pressures, sample mixed venous blood, and infuse solutions. The catheters are composed of a dual lumen body tube. The distal lumen terminates at the tip and is used to monitor pulmonary artery and wedge pressures. The distal lumen may also be used to sample venous blood and infuse solutions. The second lumen is used only to inflate the latex balloon which can be found at the distal end of the catheter. The function of the balloon is to enable the catheter to float down the bloodstream into the pulmonary artery. The balloon is inflated with a 3 cc syringe, which is connected to the inflation valve at the inflation lumen hub. The device will be packaged in a tray sealed with a tyvek lid and sterilized using 100% ethylene oxide.

The provided text describes the 510(k) summary for the "Edwards Lifesciences Swan-Ganz Monitoring Catheter with Oligon™ material". This is a traditional medical device submission, not an AI/ML medical device, and therefore the standard acceptance criteria and study designs for AI/ML devices, such as those involving image analysis, multi-reader multi-case studies, or algorithm-only performance, do not apply.

Here's an analysis based on the provided text, adapted for a non-AI/ML medical device:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, acceptance criteria are generally met through comparability to a predicate device and established performance standards, rather than specific numerical metrics for "performance" as one would expect with an AI/ML diagnostic.

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

• Sample Size for Test Set: Not explicitly stated. The functional and biocompatibility testing involved physical samples of the device, but the number of units tested is not detailed in this summary.
• Data Provenance: The "Test Summary, In-vitro" and "Test Summary, Bi-ocompatability" indicate internal laboratory testing conducted by Edwards Lifesciences LLC. The summary does not provide country of origin for the data (beyond the submitter's location in Irvine, California, USA) nor if it was retrospective or prospective, though device testing is typically prospective.

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

• Number of Experts & Qualifications: Not applicable in the context of this device and the provided submission. "Ground truth" for a physical medical device typically refers to established engineering standards, material science principles, and biological safety guidelines (e.g., ISO standards), rather than expert consensus on diagnostic images. Biocompatibility testing follows standardized protocols evaluated by qualified toxicologists or biologists, but specific details of expert roles are not in a 510(k) summary.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Adjudication methods like "2+1" or "3+1" are relevant for expert review of diagnostic findings (e.g., in radiological studies). This device undergoes lab-based functional and biocompatibility testing against defined specifications.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is specific to diagnostic aids, particularly those involving human interpretation of medical images or data, often with AI assistance. This device is a catheter, not an AI diagnostic.
• Effect Size of Human Readers: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Standalone Study: No, a standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done. This concept applies to AI/ML algorithms, not physical medical devices like a catheter.

7. Type of Ground Truth Used

• Type of Ground Truth: For the functional testing, the "ground truth" would be established engineering specifications and performance benchmarks for intravascular catheters (e.g., pressure sensor accuracy, balloon inflation volume, material strength). For biocompatibility, the ground truth is defined by international standards (ISO 10993-1-1994) which outline acceptable biological responses to medical devices. There's no pathology or outcomes data used as "ground truth" for the pre-market evaluation described.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device does not involve an AI/ML algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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