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The CVSi™ Peripheral Balloon Catheter and the CVSi™ Catheter Inflation Unit are indicated for percutaneous, transluminal angioplasty of stenotic lesions in the superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSj™ 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 cylinder.

The provided text describes a 510(k) premarket notification for the CVSi™ Peripheral Balloon Catheter System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for AI/ML-based devices.

Therefore, many of the requested details, such as sample sizes for test/training sets, the number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment for the training set, are NOT applicable to this submission.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in the format typically seen for AI/ML device performance. Instead, it relies on demonstrating function and safety through a series of tests and showing substantial equivalence to predicate devices.

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The CVSi™ Peripheral Balloon Catheter and the CVSi™ Inflator are indicated for percutaneous, transluminal angioplasty of stenotic lesions in superficial femoral and popliteal arteries. The CVSi™ Peripheral Balloon Catheter System is not indicated for use in other vasculature, including coronary arteries, carotid arteries, synthetic vascular grafts, and vein grafts. The CVSi™ Peripheral Balloon Catheter System is not indicated for stent delivery or stent expansion.

The CVSi™ Peripheral Balloon Catheter System consists of a CVSi™ Peripheral Balloon Catheter, CVSi™ Inflator, connecting cable, and a rechargeable battery pack with recharging unit and battery receptacle. The inflation medium (liquid nitrous oxide) is provided in a disposable 12 gr cylinder.

The provided 510(k) Premarket Notification for the CVSi™ Peripheral Balloon Catheter System outlines functional and biocompatibility testing, but it does not include the detailed performance metrics, acceptance criteria, or specific study designs (like sample sizes, ground truth establishment, or expert involvement) that would typically be associated with AI/ML device evaluations. This document describes a traditional medical device submission, focusing on equivalence to predicate devices rather than AI performance.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert involvement, and comparative effectiveness studies for an AI device cannot be extracted from this document.

However, based on the information provided, here's what can be stated:

Acceptance Criteria and Device Performance (Limited Information for AI/ML)

Since this is a submission for a traditional medical device (a balloon catheter system), not an AI/ML device, the concept of "acceptance criteria" and "reported device performance" in the AI/ML context (e.g., sensitivity, specificity, AUC) is not applicable here.

The document states that:

• Functional Performance Testing: "All testing conducted confirmed the acceptability of the CVSi Peripheral Balloon Catheter System to perform as intended."
• Biocompatibility Evaluation: "The CVSi Peripheral Balloon Catheter System materials passed the necessary biocompatibility tests, in conformance with ISO 10993-1..."

Table of Acceptance Criteria and Reported Device Performance (as far as can be inferred for a traditional device):

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