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WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries.

The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.

The document describes the acceptance criteria and study findings for the WIRION™ Embolic Protection System (EPS).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: 103 patients were enrolled in the WISE LE clinical study.
• Data Provenance: The study was a prospective clinical study (referred to as "WISE LE clinical study") conducted to support the expanded indication of the WIRION™ EPS. The country of origin is not explicitly stated in the provided text, but it is implied to be multinational given the FDA submission context.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The ground truth for the primary endpoint (MAE) was established by an independent Clinical Events Committee (CEC).
• The number of experts within the CEC is not specified.
• Their specific qualifications are not explicitly stated, beyond being an "independent Clinical Events Committee." It is generally understood that such committees are comprised of medical professionals relevant to the study area (e.g., cardiologists, interventional radiologists).

4. Adjudication Method for the Test Set:

• The adjudication method for Major Adverse Events (MAE) was done by an independent Clinical Events Committee (CEC). This suggests a consensus-based review by multiple experts, rather than a simple 2+1 or 3+1 rule which usually refers to isolated expert reads.

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:

• No MRMC comparative effectiveness study was done. This study is for a medical device (embolic protection system), not an AI-based diagnostic or assistive software.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. The WIRION™ is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used:

• For the primary endpoint (MAE), the ground truth was established based on clinical outcomes data adjudicated by an independent Clinical Events Committee (CEC). This involved assessing serious adverse events such as death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection, distal embolism, unplanned amputation, or clinically-driven target vessel revascularization.
• For other endpoints like device, clinical, and technical success, the ground truth was based on procedural observations and clinical outcomes.

8. The Sample Size for the Training Set:

• Not applicable in the context of this device. The WIRION™ is a physical medical device, not an AI/machine learning system that requires a "training set" in the conventional sense. The "WISE LE clinical study" served as the primary clinical validation (test set) for the expanded indication.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable as there is no "training set" for an AI algorithm. The device's design and previous versions were based on engineering principles and prior clinical experience. The previous K143570 clearance also involved clinical data, which could be considered foundational, but not a "training set" for an AI model.

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The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries.

The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator.

Here's a breakdown of the acceptance criteria and the study details for the WIRION™ Embolic Protection System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "All tests met their predetermined acceptance criteria," but it does not provide a specific table of these criteria. Instead, it details the observed performance of the primary and secondary endpoints in the clinical study.

Study Details:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: 120 patients
• Data Provenance: Clinical studies. The text does not explicitly state the country of origin but implies a multicenter study, and it mentions "historic control" which suggests a comparison to existing data from potentially various sources. The study was prospective, open label, and single arm.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not provide details on the number or specific qualifications of experts used to establish ground truth for the clinical study. MACCE (Major Adverse Cardiac and Cerebrovascular Events) rates and other clinical endpoints are typically determined by clinical outcomes and adjudicated by study investigators or independent clinical events committees, but the specific structure is not described here.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1). Clinical trials typically use independent adjudication committees for primary endpoints like MACCE, but this detail is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or mentioned. This device is an embolic protection system (a physical medical device), not an AI-powered diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a standalone algorithm performance study was not done. This is a physical medical device. The performance refers to its function within the human body during a medical procedure, not an algorithm's output.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on outcomes data (MACCE rates, device success, clinical success, angiographic success, procedural success, complications) observed in human patients during the study.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. This is a physical medical device, not a software algorithm that would require a training set. The clinical study described involved 120 patients.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an algorithm mentioned, this question is not applicable. For the clinical study, the ground truth was established by clinical observation and assessment of patient outcomes.

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