(95 days)
The FiberNet® Embolic Protection System is indicated for use as a guidewire and emboli protection system to capture and remove embolic material (thrombus/debris) produced while performing percutaneous transluminal interventional procedures in carotid arteries in high surgical risk patients with reference vessel diameters of 3.5 to 7.0mm.
The system consists of a fiber filter on a 0.014" guidewire with attachable actuator tool (capture wire) and a 0.014" guidewire compatible aspiration catheter with attachable stopcock assembly (Xtract catheter, K071529). System accessories included in the package consist of two 30 ml syringes, a peel-away introducer, an actuation template, and a 40µm cell strainer cup.
Here's an analysis of the provided information regarding the FiberNet® Embolic Protection System and its acceptance criteria and supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state numerical acceptance criteria with specific thresholds for the FiberNet® Embolic Protection System. Instead, it refers to meeting a "performance goal based on ARCHeR3."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acceptable performance based on ARCHeR3 (Embolic Protection System rates) | FiberNet EPS rate met the performance goal based on ARCHeR3 |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the exact sample size (number of patients) in the clinical study (EPIC Trial).
- Data Provenance: The EPIC Trial was a "non-randomized multi-center study." This indicates that the data was collected prospectively from multiple clinical sites. The country of origin is not specified, but typically for FDA submissions, studies are either conducted in the US or in countries with comparable regulatory and ethical standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide details on the number of experts or their qualifications for establishing ground truth in the EPIC Trial. Clinical studies for such devices typically involve expert clinicians (e.g., interventional cardiologists, vascular surgeons) for patient selection, procedure performance, and outcome assessment, but the document does not specify a separate "ground truth" establishment process by a distinct panel of experts.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set in the clinical study. Clinical trials typically have independent clinical events committees (CECs) to adjudicate adverse events, but this is not explicitly detailed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study described (EPIC Trial) focused on the safety and performance of the FiberNet EPS itself, comparing its performance against a statistical performance goal derived from a predicate study (ARCHeR3), not a comparison between human readers with and without AI assistance or any multi-reader setup involving different interpretations.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the FiberNet® Embolic Protection System. This is a medical device (physical product), not an artificial intelligence algorithm or software. Therefore, there is no "algorithm only" performance to evaluate.
7. Type of Ground Truth Used
Given that this is a clinical trial for a physical medical device, the "ground truth" would be based on:
- Clinical Outcomes: Observed patient outcomes related to device safety (e.g., adverse events, stroke rates) and performance (e.g., successful embolic material capture and removal, procedural success).
- Imaging Interpretation: For assessing device placement and effectiveness, imaging (angiography, ultrasound) would be used, interpreted by the treating physicians and potentially reviewed by an independent core lab, though specifics are not provided.
- Pathology/Histology: If embolic material was retrieved, it would likely be sent for pathological analysis, but the document does not elaborate on this.
The primary "ground truth" for the overall device performance would be the clinically observed event rates and outcomes in the study population.
8. Sample Size for the Training Set
This question is not applicable as the FiberNet® Embolic Protection System is a physical medical device, not an AI/software product requiring a "training set." The clinical study (EPIC Trial) serves as the primary evidence for its safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no "training set" for this physical medical device.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).