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The VesPenetrator®, VesTraveler® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction

The VexPander® Coronary Dilatation Balloon Catheters are indicated for:
· balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis in patients evidencing coronary ischemia for the purpose of improving myocardial perfusion
· balloon dilatation of a coronary artery occlusion for the treatment of acute myocardial infarction
· in-stent restenosis
· post-delivery expansion of balloon expandable coronary stents

The Coronary Dilatation Balloon Catheter (VesPenetrator®, VesTraveler® and VexPander®) is a percutaneous transluminal coronary angioplasty (PTCA) is indicated for balloon dilatation of the stenotic portion of a coronary artery. Balloon diameters ranged from 1.5mm to 4.0mm. The balloon is made of Nylon material with a rated burst pressure of 16 atmospheres (atm) for both VesPenetrator and VesTraveler, and 18atm for VexPander. The proximal shaft of the catheter is composed of a female luer connector bonded to a PTFE coated stainless steel tube. The proximal shaft joins with a smooth transition to a distal shaft composed of an outer tube of nylon or Pebax and a tri-extrusion inner tube with a balloon welded to both tubes at the distal tip. Two radiopaque platinum marker bands are positioned within the balloon shoulders. The inner tube accepts a standard 0.014 inch guidewire. The guide wire enters the catheter's tip and advances coaxially out the distal Rx port, thereby allowing both coaxial guidance and rapid exchange of catheter with a single standard length guide wire. Two marked sections of 5mm length each located on the proximal shaft indicate catheter position relative to the tip of the brachial artery or the guide tube of the femoral artery.

The provided text is a 510(k) Summary for a medical device (Coronary Dilatation Balloon Catheters). It describes the device, its intended use, comparison to predicate devices, and the performance data that supports its substantial equivalence. However, this document does not contain information about an AI-based device or a study that involves human readers, ground truth establishment by experts, or MRMC studies.

The "Performance Data" section (Page 5 and 6) lists various non-clinical engineering tests performed on the balloon catheters (e.g., balloon inflation/deflation time, bond strength, flexibility, etc.) and biocompatibility testing. These are physical tests to ensure the device performs as expected and is safe for use in the human body.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, expert ground truth, MRMC studies, or training/test set details because this document does not pertain to an AI/ML medical device.

Here's why the requested information cannot be extracted from the provided text:

• No AI Device: The device described (Coronary Dilatation Balloon Catheter) is a physical medical instrument, not a software or AI-driven diagnostic/assistive tool.
• No AI-Specific Acceptance Criteria: The acceptance criteria mentioned relate to the physical and functional performance of the catheter (e.g., burst pressure, flexibility), not AI performance metrics like sensitivity, specificity, AUC, or concordance with human readers.
• No Human Readers/Experts: There is no mention of a study involving human readers (e.g., radiologists, cardiologists) or experts establishing ground truth for diagnostic purposes. The "experts" in this context would likely be engineers or quality control personnel evaluating the physical device.
• No MRMC Study: An MRMC (Multi-Reader Multi-Case) study is specific to evaluating the impact of AI on human diagnostic performance. This is not applicable here.
• No Training/Test Sets: The concepts of training sets and test sets are relevant to machine learning model development and evaluation, which is not described. The "testing" mentioned is laboratory testing of the physical catheter.
• No Ground Truth for AI: The "ground truth" for a physical device is its engineered specifications and performance under defined conditions, not "expert consensus" or "pathology" in the context of an AI-driven diagnosis.

In summary, the provided document relates to the regulatory clearance of a physical medical device (coronary balloon catheter) through substantial equivalence, based on engineering and biocompatibility testing, not an AI/ML device.

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