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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

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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The Paladin System with Integrated Embolic Protection (IEP) is indicated for Percutaneous Transluminal Angioplasty (PTA) in the carotid arteries with capture and removal of embolic material. This device is also indicated for post-dilation of self-expanding stents in the carotid arteries with capture and removal of embolic material. The diameter of the arterial site for filter deployment should be no more than 7.0 mm. The Paladin System with IEP should always be used in conjunction with an available embolic protection device.

The Paladin System is a sterile, single use, rapid exchange (RX) PTA catheter with a nitinol-based filter between the PTA balloon and the distal tip of the catheter. The balloon has radiopaque markers to aid in accurate positioning under fluoroscopic guidance. The dilation balloon is designed to inflate to a known diameter and length at a specific inflation pressure. Paladin has balloon diameters Ø of 5.0 mm and 5.5 mm and balloon lengths of 20 mm and 30 mm. The embolic protection filter is composed of a nitinol braid chassis with an overlying polyurethane membrane with radiopaque markers on either end and radiopaque markers on the filter. The catheter has a guidewire lumen, an inflation/deflation lumen, and a filter activation wire lumen. The guidewire lumen permits the passage of a guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The proximal end of the catheter has a handle that controls activation. The filter is identical across all sizes of balloons and can be expanded to a maximum diameter of 7 mm. The Paladin System is designed to be introduced through a 6 French vascular sheath.

The provided text does not contain specific acceptance criteria for a device, nor does it detail a study proving the device meets those criteria in a format applicable to evaluating AI/ML models (e.g., performance metrics like accuracy, sensitivity, specificity, sample sizes for test/training sets, expert qualifications, or ground truth establishment).

The document is a 510(k) summary for the "Paladin Carotid Post-Dilation Balloon System with Integrated Embolic Protection." It focuses on establishing substantial equivalence to predicate devices for regulatory clearance.

Instead of acceptance criteria and a study proving their fulfillment, the document provides:

• Indications for Use: The Paladin System is indicated for Percutaneous Transluminal Angioplasty (PTA) in carotid arteries and post-dilation of self-expanding stents in carotid arteries, with integrated embolic protection.
• Summary of Non-Clinical Data: This includes design verification in-vitro testing (e.g., dimensional verification, torque response, balloon burst pressure, embolic capture efficiency), biocompatibility testing, and animal testing (acute and chronic studies in swine). These tests are designed to demonstrate the device's physical and biological safety and performance characteristics, but they are not presented as numerical acceptance criteria against reported device performance in the context of an AI/ML system's evaluation.
• Summary of Clinical Data: A multi-center study in Germany with 106 subjects assessing acute safety and clinical performance.
  • Primary Outcome: Combined major adverse event (MAE) rate at 30 days (stroke, myocardial infarction, death) was 0.98%.
  • Related Events: One major stroke at day 12 (antiplatelet non-compliance), attributed to patient non-compliance, not the device.
  • Procedural Success Rate: 100%
  • Technical Success Rate: 99%
  • Patient Demographics: Age, gender, diabetes, hypertension, hyperlipidemia, smoking status, symptomatic status, lesion length, and percent diameter stenosis.

Therefore, it is not possible to generate the requested table and information as the provided text pertains to a medical device's 510(k) submission, not an AI/ML model's performance evaluation.

The document describes the traditional regulatory process for a medical device (a physical system) and its clinical trial outcomes, not the validation of an algorithmic device with respect to specific performance metrics like those typically outlined for AI/ML.

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