(86 days)
The GORE Flow Reversal System is intended to provide embolic protection during carotid artery angioplasty and stenting for the patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:
- Adequate iliac/femoral access
- Common carotid artery diameters between 6 and 12 mm
- External carotid artery diameters less than 6 mm
The GORE Flow Reversal System consists of three primary components:
- GORE Balloon Sheath
- GORE Balloon Wire, and
- GORE External Filter
When assembled together, the GORE Flow Reversal System reverses the flow of blood at the treatment site of the internal carotid artery (ICA), directing embolic particles away from the neurovascular circulation and removing them through an external filter.
The GORE Flow Reversal System was evaluated in the Gore EMPiRE Clinical Trial, a prospective, multicenter, nonrandomized, single-arm study. The study compared the 30-day safety and efficacy of the GORE Flow Reversal System (used with FDA-approved carotid stents) to an objective performance criterion (OPC) derived from prior carotid artery stenting studies that used distal embolic protection devices.
1. A table of acceptance criteria and the reported device performance
The provided text only explicitly states that the GORE Flow Reversal System "met the OPC hypothesis defined for the study." It does not detail the specific numerical acceptance criteria or the precise reported device performance metrics against those criteria. The acceptance criteria were an "objective performance criteria (OPC) determined from prior carotid artery stenting studies where distal embolic protection devices were used." Without the specifics of the OPC, a direct comparison table cannot be generated.
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: 245 pivotal subjects.
- Data provenance: Prospective, multicenter, nonrandomized, single-arm study conducted across 29 US sites.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide information on the number of experts used to establish the ground truth, nor their qualifications. The study focused on clinical outcomes compared to an Objective Performance Criteria (OPC), rather than subjective expert interpretation for ground truth establishment.
4. Adjudication method for the test set
The document does not describe any specific adjudication method for establishing ground truth for the test set. Given it was a clinical trial, outcomes would likely be assessed by the treating physicians and potentially reviewed by a clinical events committee, but the details of this are not provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study was a single-arm clinical trial evaluating the GORE Flow Reversal System itself, not comparing human readers' performance with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The GORE Flow Reversal System is a medical device (an embolic protection system), not an AI algorithm. A "standalone" performance assessment for an algorithm is therefore not relevant in this context. The study evaluated the standalone performance of the physical device in a clinical setting.
7. The type of ground truth used
The ground truth was based on the safety and efficacy outcomes of the 245 pivotal subjects at 30 days, compared against a pre-defined Objective Performance Criteria (OPC) derived from historical clinical studies of similar devices. This is effectively a form of outcomes data compared against a benchmark.
8. The sample size for the training set
This question is not applicable. The GORE Flow Reversal System is a physical medical device, not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This question is not applicable as there was no training set for an AI algorithm.
§ 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).