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The PolarCath Peripheral Balloon Catheter System is indicated to dilate stenosis in the peripheral vasculature (iliac, femoral, iliofemoral, popliteal, infrapopliteal and renal arteries) and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.

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 native arteriovenous dialysis fistulae.

The PolarCath Peripheral Balloon Catheter System consists of a Peripheral Balloon 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 does not contain detailed information about specific acceptance criteria or the study that definitively proves the device meets those criteria.

However, based on the available text, here's what can be gathered regarding performance data:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and data provenance:
The document states "In vitro testing" was performed. This generally refers to testing conducted in a controlled environment, often in a lab, using non-biological materials or simulations.

• Sample Size for Test Set: Not specified.
• Data Provenance: The nature of "in vitro testing" suggests a controlled laboratory setting, not related to specific countries or retrospective/prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as the performance data is based on "in vitro testing" rather than expert-derived ground truth.

4. Adjudication method for the test set:
Not applicable, as the performance data is based on "in vitro testing" rather than expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. The device described, the PolarCath Peripheral Balloon Catheter System, is a medical device for dilating stenosis, not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used:
For "in vitro testing," the "ground truth" would typically refer to established engineering specifications, physical measurements, or validated standards against which the device's performance characteristics (e.g., burst pressure, inflation/deflation times, material compatibility, lumen integrity) are compared. The document does not specify these precise "ground truths."

8. The sample size for the training set:
Not applicable, as this device is not an AI/algorithm and therefore does not have a "training set."

9. How the ground truth for the training set was established:
Not applicable.

Summary of available information:

The 510(k) summary for the PolarCath Peripheral Balloon Catheter System (K030742) indicates that "in vitro testing demonstrated that the PolarCath Peripheral Balloon Catheter System met all acceptance criteria." However, the document does not specify what those acceptance criteria were, nor does it provide details about the "in vitro testing" itself, such as methods, sample sizes, or specific results. The information provided is very high-level and focused on the regulatory submission process rather than a detailed scientific study report.

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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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