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The Chocolate™ PTCA Balloon Dilatation Catheter is indicated for balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.

The Chocolate PTCA Balloon Catheter is a Rapid Exchange (RX) angioplasty balloon catheter. It consists of a stainless steel hypotube and a nylon shaft, a semi compliant balloon at the distal end of the catheter with a metal constraining structure (CS) and an atraumatic distal tip. Upon inflation, the CS expands with the balloon to a certain diameter; the balloon continues the expansion beyond the CS. Upon deflation, the CS returns to its original shape, and is removed from the vessel along with the balloon catheter. Two Radiopaque markers are added to define the working length of the Chocolate Balloon. The proximal end of the catheter is comprised of a hub used to inflate the balloon that can be connected to a standard inflation device. The catheter will be 140 ±5cm in length, compatible with 0.014" guidewire.

This document is a 510(k) premarket notification for a medical device, the Chocolate™ PTCA Balloon Catheter. It focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and performance testing. It does not describe an AI/ML-driven device or study results related to AI performance metrics. Therefore, I cannot provide information on acceptance criteria or study details regarding AI performance, as the provided text does not contain such information.

The document describes the device, its intended use, and lists various physical and mechanical tests performed to establish substantial equivalence. It confirms that the device is a physical medical device (a balloon catheter), not an AI/ML software device.

Key information from the provided text, but not directly related to AI/ML study parameters, includes:

• Device Name: Chocolate™ PTCA Balloon Catheter
• Intended Use: Balloon dilatation of the stenotic portion of coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
• Predicate Device: Glider PTCA Balloon Catheter (TriReme Medical) - (K111544 and K121681)
• Testing Basis: Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters (September 8, 2010).
• Types of Tests Performed (to demonstrate substantial equivalence to the predicate):
  • Dimensional Verification
  • Balloon Preparation, Deployment & Retraction
  • Flexibility & Kink
  • Balloon Rated Burst Pressure (RBP)
  • Balloon Fatigue
  • Balloon Compliance
  • Balloon Inflation and Deflation
  • Catheter Bond Strength
  • Tip Pull Test
  • Torque Strength
  • Radiopacity
  • Particulate Evaluation
  • Biocompatibility Testing
• Conclusion: The device was deemed "substantially equivalent" to its predicate, with no new questions of safety or effectiveness identified.

Therefore, I cannot populate the table or answer the specific questions about AI/ML study design and results, as this document pertains to a physical medical device and its traditional engineering and performance testing.

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