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-Refractory left ventricular failure,

-Cardiogenic or septic shock.

-Unstable refractory angina.

-Impending infarction,

-Ischemia related ventricular arrhythmias,

-Weaning from cardiopulmonary bypass,

-Support and stabilization during coronary angioplasty,

-Intraoperative pulsatile flow generation,

-Associated mechanical complications of acute myocardial infarction,

-Support and stabilization of high-risk patients undergoing general surgical procedures.

Each double lumen percutaneous TaperSeal" IAB catheter is pre-furled and has a hemostasis device attached to the catheter which may be slid down the catheter and into the insertion site as necessary in the event of excessive bleeding from the puncture site. Each TaperSeal" IAB catheter is packaged into a balloon kit that contains airway tubing, a syringe, syringe adaptor. Kontron and/or Datascope adaptor, and pressure tubing with a stopcock. The TaperSeal" IAB catheters also come packaged with an insertion kit which contains a percutaneous tear away introducer, two guidewire, an angiography needle, and a vessel dilator.

The provided text describes a 510(k) summary for the Bard TaperSeal IAB Catheters and does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria as typically found in AI/ML device submissions. The document is for a medical device (intra-aortic balloon catheter), not an AI/ML device, and therefore the requested information categories (e.g., sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies) are not applicable.

The "Performance Data" section solely states:

"Bench testing was performed to verify that the TaperSeal Catheter can withstand insertion forces associated with sheathless insertion. All testing was completed successfully."

This is a very general statement and does not provide any of the granular details requested in the prompt, such as specific acceptance criteria, reported performance values against those criteria, sample sizes, expert involvement, or ground truth methods.

Therefore, I cannot populate the requested table or provide answers to the specific questions regarding acceptance criteria and study details based on the provided text. The document is not relevant to an AI/ML device context.

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