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The BSC/CA INBC's are indicated for use in patients with the following conditions *Refractory power failure. *Cardiogenic shock. *Unstable refractory angina. *Impending or extending myocardial infarction (MI). *Hemodynamically significant mechanical complications secondary to acute MI: *Ventricular septal defect. *Mitral valve regurgitation. *Papillary muscle rupture. *Cardiac support for high risk general surgical and coronary angiography/ angioplasty patients. *Septic shock. The intended use of the 40 cc Grande. " remains identicalto that of the currently marketed IABC's. All of the devices are intended to provide temporary circulatory support of the left ventricle through controlled mechanical displacement of a volume of blood in the aorta. The mechanical action of the IAB catheter therapy lowers the cardiac workload by two means : Systolic unloading, as noted by a reduction in the patient's systolic pressure, which provides reduced myocardial oxygen consumption (MVO,). Diastolic augmentation which provides an increase in the mean aortic pressure and leads to an improvement in systemic and coronary arterial perfusion. Balloon pump therapy is achieved by inserting and intra-aortic balloon catheter into the descending thoracic aorta via the common femoral arterv. Balloon inflation is timed to occur during diastole, beginning with the aortic valve closure. The balloon remains inflated until the onset of left ventricular ejection or systole, then rapidly deflates, reducing the aortic pressure, which in turn reduces the afterload.

The proposed 40 cc Grande™ consists of a polyurethane blend symmetrical balloon at the distal end of a polyurethane-covered nylon shaft. The balloon is coated with a thin layer of silicone fluid. A polvurethane central lumen runs throughout the length of the catheter and terminates at the distal tip. This central lumen may be used to pass the device over a guidewire. The balloon is supplied prewrapped for insertion and supplied with a 0.025 inch extra stiff quidewire and 10 F introducer.

The provided text describes the non-clinical performance testing of the 40 cc Grande™ Intra-Aortic Balloon Catheter. There are no clinical studies or human reader studies reported for this device. Therefore, information regarding MRMC studies, human reader improvement with AI, or standalone algorithm performance cannot be provided.

Here's an analysis of the acceptance criteria and study findings based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

• predicate 40 cc Grande NT™ (0.100 inch)
• 40 cc Datascope 9.5 F Percor-Stat (0.100 inch)
• 40 cc 9 F Kontron/Arrow IAB (> 0.105 inch). |
  | Maximum Pumping Rate Limit Test | ≥ 90% of nominal volume inflated/deflated. | 175 bpm. | Substantially equivalent to predicate 40 cc Grande NT™ (170 bpm) and greater than Model 940 (140 bpm). |
  | Combined Inflation/Deflation Time | Not explicitly stated with a numerical criterion, but implied to be comparable to predicate. | 245 msec. | Compares favorably with predicate Model 940 (275 msec) and 40 cc Grande NT™ (264 msec). |
  | Reliability and Integrity Test | Minimum 3.6 million cycles without failure (dimensional changes, surface wear, leaks). | All 40 cc Grande™ test samples able to cycle reliably. No changes in dimensions, signs of surface wear, or leaks noted after 3.6 million cycles. Pre-reliability maximum pumping rate (175 bpm) nearly identical to post-reliability (176 bpm). Inflation/deflation times comparable post-reliability. | As reliably as the predicate devices (40 cc Grande NT™ and Model 940). |
  | Trackability Test | Catheters and insertion accessories perform without incident (no kinks, problems inserting/removing). | All 40 cc Grande™ and predicate devices tracked their guidewire into place without incident. No catheter kinks, no guidewire kinks, no problems encountered inserting or removing. | Implied to be equivalent to predicate devices. |
  | Transmembrane Pressure and Volume Measurement Test (Volume at 50 mmHg) | 40 cc +/- 5%. | 41.6 cc. | Substantially equivalent to predicate 40 cc Grande NT™ (41.7 cc). |
  | Transmembrane Pressure and Volume Measurement Test (Pressure at 40 cc displacement) |

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