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The Pantera Pro is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The Pantera Pro (balloon diameter 2.0 - 4.0 mm) is also indicated for post-delivery expansion of balloon expandable stents.

The Pantera LEO is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion and for post dilatation of coronary stents.

Pantera Pro is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

Pantera LEO is a PTCA rapid exchange system with a balloon at the distal end of the catheter. A Luer port at the proximal end enables the attachment of an inflation device for the inflation of the balloon. The catheter provides a lumen, which enables the use of a guide wire to position the catheter. Radiopaque balloon markers aid in the placement of the catheter's balloon segment under fluoroscopy.

The provided text is a 510(k) premarket notification for medical devices (Pantera Pro and Pantera LEO catheters). It focuses on demonstrating substantial equivalence to predicate devices, primarily through comparison of technological characteristics and performance data.

Crucially, this document does not contain information about studies related to Artificial Intelligence (AI) or machine learning (ML) models, nor does it provide details about human reader performance, expert adjudication, or ground truth establishment in the context of diagnostic or prognostic AI applications.

The "Performance Data" section solely mentions:

• Product performance - coating integrity and particulates
• Biocompatibility
• Microbiological - Bioburden
• Shelf-Life - coating integrity and particulates

These are standard performance metrics for physical medical devices like catheters, not for AI/ML software.

Therefore, I cannot provide the requested information for an AI/ML-based device based on this document. The information you're asking for would typically be found in a submission for a software as a medical device (SaMD) or an AI-enabled device, which this document is not.

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