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510(k) Data Aggregation
(178 days)
The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection is indicated for percutaneous transluminal angioplasty (PTA) and capture and removal of embolic material during angioplasty, for the femoral, iliac, popliteal and profunda arteries. The System is not intended for use in the renal, cerebral, coronary or carotid vasculature.
The Vanguard IEP Peripheral Balloon Angioplasty System with Integrated Embolic Protection platform is similar to a catheter with a typical angioplasty balloon, but between the distal end of the balloon and the distal tip of the catheter, there is a nitinol-based filter. The device is over-the-wire (OTW) and is 0.018" guidewire compatible. The balloon catheter comes in sizes of 5 and 6 mms outside diameter (OD) and lengths 40, 80, 120 and 200 mms. The filter component is composed of a nitinol filter frame with an overlying membrane perforated with a set pattern of drilled holes. The balloon catheter shaft consists of a dual lumen inner shaft placed inside a single lumen outer shaft. The inner shaft extends beyond the balloon up to the distal catheter tip. Radiopaque markers placed on either side of the balloon and the distal tip of the filter assist with accurate placement. The nitinol filter frame has radiopaque markers, making the diameter of the filter visible when opened. The proximal end of the nitinol frame slides freely over the distal shaft. A pull-wire attaches the handle to the filter frame to activate the filter.
Here's a breakdown of the acceptance criteria and study information for the Contego Medical Vanguard IEP Peripheral Balloon Angioplasty System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria | Acceptance Value (Target) | Reported Device Performance |
|---|---|---|
| Safety: Freedom from Major Adverse Events (MAE) at 30 days post-procedure | > 88% (pre-specified performance goal, PG) | 100.0% (with a 97.5% lower confidence limit of 96.2%) |
| Effectiveness: Procedural Success (defined as <50% residual stenosis without any MAE prior to hospital discharge) | (Explicit target not stated, but implied to be achieved) | Met |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 113 subjects enrolled, 112 available for 30-day follow-up.
- Data Provenance: Prospective, multicenter study conducted across nine centers in Belgium and Germany.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
The document does not explicitly state the number or qualifications of experts used to establish ground truth for the test set. Clinical endpoints like MAE and procedural success are typically assessed by the treating clinicians and/or adjudicated by an independent clinical events committee (CEC), but details on this are not provided in the summary.
4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). It states that the "conduct of this study is in compliance with ISO Study 14155:2011, Good Clinical Practices (GCP) and the Declaration of Helsinki," which implies rigorous oversight, but the specific adjudication process is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is a medical device for angioplasty and embolic protection, not an AI or imaging diagnostic device that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used
The ground truth was established through clinical outcomes data (e.g., occurrence of death, amputation, target vessel revascularization at 30 days, and residual stenosis). This would be based on clinical assessments, imaging results, and patient follow-up during the clinical study.
8. Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set. The "training" of the device itself would refer to its design and manufacturing processes, which are informed by engineering principles, bench testing (in-vitro), and animal studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as it's not an AI/ML device. For physical devices, validation comes from:
- Bench Testing (in-vitro): Evaluating various physical and mechanical properties against pre-defined engineering standards and performance requirements (e.g., dimensional verification, balloon integrity, filter capture efficiency).
- Animal Testing: Assessing safety and performance in a relevant physiological environment (e.g., in a swine model for thrombus capture and histological analysis of treated arteries).
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