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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
• 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.

Here's an analysis of the provided text regarding the acceptance criteria and study for the GORE® Flow Reversal System (K123156), based only on the information given:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the provided document does not explicitly state specific acceptance criteria in terms of numerical thresholds or performance targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

The reported device performance primarily revolves around qualitative assessments:

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide information on a "test set" or any clinical study involving patient data (retrospective or prospective). The evaluations mentioned are described as "non-clinical evaluations."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not mentioned in the document, as no clinical test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

This information is not mentioned in the document, as no clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No MRMC comparative effectiveness study is mentioned in the provided text. The evaluation is focused on demonstrating substantial equivalence through non-clinical testing, not on comparative effectiveness with human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a physical medical device (catheter system) and not an algorithm or AI system.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to performance studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable to the "non-clinical evaluations" described. The "truth" in this context is based on engineering specifications, regulatory standards (e.g., ISO 10993-1), and comparison to the predicate device's established characteristics through physical and functional testing.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device and not an AI system that undergoes training.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical medical device and not an AI system.

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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.

Ask a specific question about this device