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510(k) Data Aggregation
(77 days)
Gardia Medical Ltd.
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 ( |
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(169 days)
GARDIA MEDICAL
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.
| Endpoint Category | Acceptance Criteria (Implied/Performance Goal) | Reported Device Performance |
|---|---|---|
| Primary Endpoint | MACCE rate 95%) for all functions | Device success: 99.2% |
| Clinical success: 97.5% | ||
| Angiographic success: 99.2% | ||
| Procedural success: 98.3% | ||
| Secondary Endpoints (Complications) | Low incidence of complications | Access site complications: 1.7% |
| Neurological events: 4.1% |
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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