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The device indications for use are as follows: 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 Intraoperative pulsative now generals of acute myocardial infarction Associated mechanical computations of actions in action in the many of any ical procedures.

Each Intra Aortic Balloon catheter comes with a catheter tray and an introducer tray. The catheter tray contains: a 9Fr. 30cc IAB catheter, airway tubing w/female luer fitting, 6" pressure tubing with stopcock, a 3 way stopcock, a 60cc syringe, an optional Datascope or Arrow adaptor, 36" pressure tubing, and a male luer lock cap. The accessory tray contains; a percutaneous tearaway introducer, 8" or 11" introducer dilators, 18 gauge angiography needle, and two 150cm floppy J guidewires.

The provided text does not contain any information about acceptance criteria or a study proving that the device meets specific performance criteria.

The document is a 510(k) Summary for a medical device (Bard 9Fr., 30cc. RediGuard and TaperSeal Intra-Aortic Balloons), which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Here's what the document does include:

• Device Description and Intended Use: Details about the intra-aortic balloon catheters and their clinical applications.
• Comparison to Predicate Device: A table (Table VI-I) highlighting that the new device has the "Same" indications for use, contraindications, packaging, and sterilization as the predicate device. This is crucial for demonstrating substantial equivalence, not performance against specific criteria.
• Performance Data (G): It states: "The Bard RediGuard and TaperSeal IAB catheters were subjected to biocompatibility testing as outlined in FDA's May 1, 1995 General Program memorandum- #G95-1 Attachment A, and to the FDA's current guidelines on IAB testing. All testing was successfully completed."
  • This indicates that some testing was done (biocompatibility, and IAB-specific testing per FDA guidelines), and it was "successfully completed." However, it does not provide any specific acceptance criteria, numerical performance results, or details about the studies themselves (e.g., sample size, ground truth, experts).

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert involvement. The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with quantifiable acceptance criteria.

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