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The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

This request cannot be fulfilled. The provided text is a 510(k) summary for a medical device (PolarCath™ Peripheral Dilatation System) and does not contain information about studies related to AI/algorithm performance, acceptance criteria for such, or details like sample sizes for training/test sets, expert qualifications, or ground truth establishment. The document describes a traditional medical device submission based on substantial equivalence to a predicate device, not an AI-powered device.

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The PolarCath Peripheral Dilatation System is indicated to dilate stenoses in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal, renal and subclavian arteries) and for the treatment of obstructive lesions of polytetrafluoroethylene (PTFE) access grafts or native arteriovenous dialysis fistulae. The PolarCath Peripheral Dilatation System is also indicated for post-deployed stent expansion of self-expanding peripheral vascular stents.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

This 510(k) submission for the PolarCath™ Peripheral Dilatation System does not include a study describing acceptance criteria and device performance.

Instead, it states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at Boston Scientific." This typically means that the device was tested against engineering specifications and industry standards in a lab setting, rather than through clinical trials or performance studies involving human data.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (K051916) based on design, materials, manufacturing process, and intended use, rather than presenting novel performance data from an acceptance criteria study.

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The PolarCath™ Peripheral Dilatation System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of PTFE access grafts or arteriovenous dialysis fistulae.

The PolarCath Peripheral Dilatation System consists of a Catheter, Inflation Unit, connecting cable and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 14 gram cartridge.

The provided text describes a 510(k) premarket notification for the PolarCath™ Peripheral Dilatation System, which is a Percutaneous Transluminal Angioplasty Catheter. The document is a regulatory submission, not a study report, and therefore does not contain the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

The "Performance Data" section explicitly states: "The safety and effectiveness of the modified PolarCath Peripheral Dilatation System is demonstrated with design control activities and bench testing on file at CryoVascular Systems, Inc." This indicates traditional device testing (bench testing, design controls) was performed, not clinical studies involving AI performance metrics.

Therefore, I cannot provide the requested table and study details as they are not present in the provided document.

This document is from 2004, a period before AI/ML-driven medical devices were commonly evaluated in the same manner as described in your request. The evaluation framework for devices like this involved demonstrating substantial equivalence to a predicate device through engineering design, material specifications, manufacturing processes, and bench testing, rather than through extensive clinical performance studies with AI components.

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