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The Mozec - Rx PTCA Balloon Dilatation Catheter 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 Mozec - Rx PTCA Balloon Dilatation Catheter (balloon models 2.25mm) is also indicated for post delivery expansion of balloon expandable stents.

The Mozec NC – Rx PTCA Balloon Dilatation Catheter 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 Mozec NC - Rx PTCA Balloon Dilatation Catheter is also indicated for post delivery expansion of balloon expandable stents.

Mozec - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a semi-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec balloon's working length (2.00 mm to 4.50 mm sizes) or the centre of the balloon's working length (1.50 mm size). The Mozec balloons are offered in diameters ranging from 1.50 mm to 4.50 mm and lengths varying from 9 mm to 41 mm.

Mozec NC - Rx PTCA Balloon Dilatation Catheter is a sterile, single use rapid exchange catheter consisting of a non-compliant balloon, a soft tip, a dual lumen distal shaft and a single lumen proximal shaft. Radiopaque platinum/iridium marker(s) contained in the balloon segment facilitate fluoroscopic visualization of the proximal and distal ends of the Mozec NC balloon's working length. The Mozec NC balloons are offered in diameters ranging from 2.00 mm to 4.50 mm and lengths varying from 8 mm to 38 mm.

The provided document is a 510(k) premarket notification for PTCA (Percutaneous Transluminal Coronary Angioplasty) Balloon Dilatation Catheters. It describes the device, its intended use, and non-clinical performance data to demonstrate substantial equivalence to previously cleared predicate devices.

However, the document does not contain information related to an AI/ML medical device, nor does it discuss acceptance criteria and studies proving the device meets those criteria in the context of AI/ML performance. Instead, it refers to standard engineering and performance tests for medical devices like balloon catheters.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this text. The questions posed in your prompt (e.g., sample size for test set/training set, number of experts for ground truth, MRMC study, standalone performance) are specific to the validation of AI/ML algorithms, which is not the subject of this document.

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