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510(k) Data Aggregation
(77 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Study Endpoint: Freedom from Major Adverse Events (MAE) to 30 days post-procedure. Historic controls average MAE rate: 10.6%. Performance Goal (PG) for WIRION™ was not explicitly stated as a numerical value but the study aimed to show superiority/non-inferiority to the historical control. | MAE Rate: 1.9% (2 out of 103 patients). The P-value obtained (<0.0001) was significantly lower than one-sided alpha = 0.0068, indicating the primary endpoint was met. This demonstrates a significantly lower MAE rate compared to the historical control. |
| Device Success: Successful delivery and deployment of WIRION™ distal to the intervention site without complications, and successful retrieval of WIRION™ following completion of the stenting procedure, without complications. | Device Success Rate: 95.1% for the ITT (Intention-To-Treat) population and 94.6% for the PP (Per-Protocol) population (98 out of 103 patients). |
| Clinical Success: Device success with freedom from procedure-related serious adverse events ascribed to the WIRION™. | Clinical Success Rate: 94.2% (97 out of 103 patients) for cases where WIRION™ was successfully used and a good clinical outcome was achieved. |
| Technical Success: Freedom from device malfunctioning causing the procedure to be aborted. | Technical Success Rate: 97.1% for the ITT population and 96.7% for the PP population (technical failure occurred in 3 cases). |
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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