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ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have the appropriate anatomy described below:

• Adequate femoral venous access
• Common carotid artery reference diameter of at least 6 mm.
• Carotid bifurcation is a minimum of 5 cm above the clavicle as measured by duplex Doppler ultrasound (DUS) or computerized axial tomography (CT) angiography or magnetic resonance (MR) angiography

Silk Road Medical, Inc. is the manufacturer of a single use device intended to provide embolic protection during carotid artery angioplasty and stenting procedures. The ENROUTE Transcarotid NPS is designed to transport emboli away from the carotid artery circulation by reversing blood flow at the treatment site prior to crossing a lesion in the carotid artery and during lesion manipulation. It has an in-line filter used to capture and contain embolic material liberated during the procedure.

The ENROUTE Transcarotid NPS consist of three primary components: the ENROUTE Transcarotid Arterial Sheath (Model #1016), the ENROUTE Venous Return Sheath (Model #1026), and the ENROUTE Flow Controller (Model #2031). When assembled, the ENROUTE Transcarotid NPS creates an Arteriovenous Shunt. The Transcarotid Arterial Sheath is placed in the carotid artery below the carotid bifurcation. The Venous Return Sheath is placed into the femoral vein. The Arterial and Venous Sheaths are connected by the Flow Controller, thereby completing the Arteriovenous Shunt. When the carotid artery is occluded just proximal to the Transcarotid Arterial Sheath insertion site, the arterial/venous pressure gradient diverts or reverses the internal carotid artery (ICA) and external carotid artery (ECA) blood flow thereby directing the blood from the cerebral arteries through the Transcarotid Arterial Sheath, through the Flow Controller, and out through the through the Venous Return Sheath into the venous circulation. The ENROUTE Transcarotid NPS is an ethylene oxide sterilized, non-pyrogenic, single-use prescription device.

The associated accessory for use with the ENROUTE Transcarotid NPS is an FDA cleared 0.038" quidewire (K890959). The quidewire is used to facilitate the insertion of the Transcarotid Arterial Sheath into the common carotid artery (CCA) and the Venous Return Sheath into the femoral vein.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document focuses on the ROADSTER study's primary endpoint as the key acceptance criterion for effectiveness.

Additional secondary endpoints and their performance are mentioned, but the primary endpoint is explicitly tied to meeting the acceptance criteria.

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

• Test Set Sample Size: 141 pivotal subjects.
• Data Provenance: Prospective, single-arm, multi-center clinical trial (ROADSTER study). Seventeen (17) sites in the United States of America and one (1) in the European Union participated.

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

The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth related to outcomes like stroke, MI, and death. It mentions that subjects "suspected of having a stroke were asked to return at 3 months post procedure for a follow-up neurological exam" and those suspected of "cranial nerve injury were asked to return at 6 months post-procedure for a follow up neurological examination," implying clinical evaluation by qualified medical professionals. However, it doesn't detail a formal expert consensus process for determining the final ground truth of these endpoints for the study as a whole.

4. Adjudication Method for the Test Set

The document does not explicitly describe a formal adjudication method (e.g., 2+1, 3+1) for the clinical endpoints (stroke, MI, death) in the ROADSTER study. It states that "subjects were followed for 30-days post procedure" and mentions follow-up neurological exams for suspected events, implying assessment by the treating physicians or study neurologists.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This study is evaluating the safety and effectiveness of a medical device (ENROUTE Transcarotid Neuroprotection System), not the performance of an AI algorithm in interpreting medical images.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done.

No, a standalone (algorithm only) performance study was not done as this is a medical device for a surgical procedure, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for the clinical study (ROADSTER) was based on clinical outcomes data, specifically:

• Incidence of stroke (evaluated by neurological exam)
• Myocardial infarction
• Death

These endpoints would be determined by clinical assessment, diagnostic tests, and follow-up data as collected in a standard clinical trial.

8. The Sample Size for the Training Set

This document describes a clinical study for a medical device. There is no mention of a "training set" in the context of an AI algorithm. The study described is a clinical trial evaluating the device itself.

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

As there is no training set for an AI algorithm discussed in this document, this question is not applicable. The document describes clinical studies and bench testing for a medical device.

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