(175 days)
The GORE® Embolic Filter system is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
The GORE® Embolic Filter system consists of a device, a delivery catheter, and a retrieval catheter, and is compatible with guiding catheters and sheaths having a minimum inner diameter of 0.066". The GORE® Embolic Filter is indicated for general use as a guidewire and embolic protection system during angioplasty and stenting procedures in carotid arteries with reference vessel diameters of 2.5 to 5.5mm.
Acceptance Criteria and Study Details for GORE® Embolic Filter
This document describes the acceptance criteria and supporting study for the GORE® Embolic Filter, based on the provided 510(k) summary.
Note: The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel safety and effectiveness criteria through a full-scale clinical trial with specific performance goals for de novo approval. Therefore, the "acceptance criteria" here are framed around successful demonstration against a performance goal derived from existing carotid stent studies using embolic protection, rather than absolute, pre-defined numerical thresholds for the device itself.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Goal Derived from Predicates) | Reported Device Performance (Gore EMBOLDEN Clinical Trial) |
|---|---|
| Safety and efficacy comparable to or better than performance goal obtained from carotid stent studies utilizing distal embolic protection. | Statistical analysis confirms that the GORE® Embolic Filter met the performance goal defined for the study. |
Explanation of "Acceptance Criteria" in this Context:
For a 510(k) submission, the "acceptance criteria" for clinical performance are typically relative to predicate devices or established performance goals. Here, the device aimed to demonstrate safety and efficacy that was non-inferior (or superior) to a performance goal established from a meta-analysis or pooled data of previously approved carotid stent studies that also used distal embolic protection. The specific numerical targets for safety and efficacy endpoints (e.g., stroke rates, major adverse cardiac and cerebrovascular events (MACCE)) that comprised this "performance goal" are not explicitly detailed in the summary but are implied to have been defined prior to the study.
2. Sample Size and Data Provenance
- Test Set Sample Size: 250 pivotal subjects.
- Data Provenance: Prospective, multicenter, nonrandomized, single-arm study conducted across Thirty five (35) US sites.
3. Number of Experts and Qualifications for Ground Truth
The provided summary does not explicitly state the number of experts used to establish ground truth for the test set from a diagnostic or image interpretation perspective. As this is an embolic filter, the "ground truth" would primarily be clinical outcomes (e.g., incidence of stroke, periprocedural complications) rather than a specific diagnostic interpretation. Therefore, the "experts" would be the clinical investigators and study personnel responsible for assessing patient outcomes. Their qualifications are implicitly assumed to be appropriate for conducting clinical trials involving carotid artery stenting procedures.
4. Adjudication Method for the Test Set
The summary does not explicitly detail an adjudication method (e.g., 2+1, 3+1). For clinical trials evaluating safety and efficacy, particularly for events like stroke or other adverse events, an independent Clinical Events Committee (CEC) is typically employed to adjudicate reported events according to pre-defined criteria. While not explicitly mentioned, this is a standard practice for trials of this nature.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is more common for diagnostic imaging AI devices where human readers interpret images. The GORE® Embolic Filter is a medical device for embolic protection during a procedure, and its performance is assessed through clinical outcomes rather than diagnostic interpretation.
6. Standalone (Algorithm Only) Performance Study
No, a standalone (algorithm only) performance study was not performed. This device is a physical medical device, not an AI algorithm. Its performance is intrinsically linked to its use by medical professionals in a clinical setting ("human-in-the-loop").
7. Type of Ground Truth Used
The ground truth used for the clinical study was primarily outcomes data. This includes:
- 30-day safety outcomes (e.g., stroke, death, myocardial infarction related to the procedure).
- 30-day efficacy outcomes (implied to be successful delivery and protection, potentially assessed by freedom from periprocedural stroke or TIA).
These outcomes are collected and assessed from the actual patients in the study.
8. Sample Size for the Training Set
This question is not applicable in the context of this device. The GORE® Embolic Filter is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The "training" for such devices typically refers to pre-clinical testing, design iterations, and eventually, the clinical trial (which acts as a validation/confirmation step rather than iterative training).
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the reasons stated above. As there is no AI/ML training set, there is no corresponding method for establishing a ground truth for a training set. The "ground truth" during the development phase would relate to engineering specifications and performance in bench and animal testing. These were mentioned as "Non-Clinical" and "Animal" studies, respectively, covering aspects like loading, deployment, retrieval, quantification of particulate, filter efficiency, and vessel damage.
§ 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).