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The ENROUTE Transcarotid Neuroprotection System (ENROUTE Transcarotid NPS) is intended to provide transcarotid vascular access, introduction of diagnosic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis and who have 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 integrated filter used to capture and contain embolic material liberated during the procedure.

Like the predicate device, the ENROUTE Transcarotid NPS consists of three primary components: the ENROUTE Transcarotid Arterial Sheath, the ENROUTE Venous Return Sheath, and the ENROUTE Flow Controller. The Subject Device offers an Angled-Tip configuration and a Straight Tip configuration of the Transcarotid Arterial Sheath. 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 blood flow in the internal carotid artery (ICA) and external carotid artery (ECA) thereby directing the blood from the cerebral arteries through the Transcarotid Arterial Sheath, through the Flow Controller with integrated filter, and out through the Venous Return Sheath into the venous circulation.

The ENROUTE Transcarotid Arterial Sheath and ENROUTE Venous Return Sheath are constructed of stainless steel reinforced thermoplastic elastomers attached to hemostasis valve adaptors. The Angled-Tip Transcarotid Arterial Sheath configuration has a 15° bend at the distal tip whereas the Straight-Tip Transcarotid Arterial Sheath configuration has no bend at the distal tip. The ENROUTE Flow Controller consists of DEHP free PVC tubing with an integrated polyester filter and polycarbonate housing. A 90cm long 0.035" PTFE coated Nitinol with stainless steel coil J-Tip Guidewire is provided with the ENROUTE Transcarotid NPS. 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.

The ENROUTE Transcarotid NPS is an ethylene oxide sterilized, non-pyrogenic, singleuse prescription device.

The provided text is a 510(k) Summary for the ENROUTE Transcarotid Neuroprotection System. It details the device, its indications for use, comparison to a predicate device, and supporting data from various tests. However, it does not describe the acceptance criteria for a device's performance, nor does it present a direct study proving the device meets established acceptance criteria in the way typically expected for a medical AI or diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (K143072) based on various performance, biocompatibility, and sterilization tests. The "acceptance criteria" mentioned are broad, such as "All bench testing met the pre-determined acceptance criteria" or "the safety acceptance criteria for the studies were met," without detailing what those criteria are (e.g., a specific sensitivity or specificity threshold, or a specified flow rate range).

Therefore, a table of acceptance criteria and reported device performance as requested, with specific quantitative metrics, cannot be fully generated from this document. Similarly, detailed information on sample sizes, ground truth establishment, expert qualifications, and MRMC studies, which are typical for AI/diagnostic device performance evaluations, are not present.

However, I can extract and present the information that is available related to the supporting data and testing.

Summary of Available Information from the Provided Document:

This document summarizes the testing performed to demonstrate substantial equivalence of the ENROUTE Transcarotid Neuroprotection System (Subject Device) to its predicate device (ENROUTE Transcarotid Neuroprotection System with Filter, K143072). The testing focused on functional performance, biocompatibility, and sterilization, rather than clinical performance metrics often associated with AI or diagnostic device acceptance criteria (e.g., sensitivity, specificity).

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "All bench testing met the pre-determined acceptance criteria" and "the safety acceptance criteria for the studies were met." Specific quantitative acceptance criteria for each test (e.g., a specific tensile strength value, acceptable flow rate range, or specific biological response thresholds) are not provided in this summary.

• Disengagement Force Dilator to Hemostasis valve
• Guidewire Advancement
• Dilator Hub Functional Testing (ISO 594-1:1986)
• Sheath Stopper Removal
• Kink Resistance
• Hemostat Clamp and Unclamp
• Air Leakage During Aspiration (ISO 10555-1:2014 and ISO 11070:2014)
• Liquid Leakage Under Pressure (ISO 10555-1:2014 and ISO 11070:2014)
• High/Low Switch Cycling
• Flow Stop Button Cycling
• Tensile Tests (ISO 10555-1:2014 and ISO 11070:2014)
• Flow Rate Characterization
• Air Emboli and Solid Emboli Transportation Simulation
• Small and Large Particle Transport and Capture Efficiency
• System Preparation and Simulated Use
• Packaging Validation (ISO 11607-1:2006[R]2010 and ISO 11607-. 2:2006[R]2010)
• Shelf Life | "pre-determined acceptance criteria" (details not provided) | "All bench testing met the pre-determined acceptance criteria." |
  | Guidewire Performance | - Tip Flexibility
• Flexing (ISO 11070:2014)
• Fracture (ISO 11070:2014)
• Coating Adhesion
• Tensile Strength (ISO 11070:2014)
• Corrosion (ISO 11070:2014) | "pre-determined acceptance criteria" (details not provided) | "All bench testing met the pre-determined acceptance criteria." |
  | Biocompatibility | - Cytotoxicity: MEM Elution L-929 ISO/USP
• Sensitization: Maximum Sensitization (Guinea Pig)
• Irritation: ISO Intracutaneous Reactivity Test
• Systemic Toxicity: ISO Acute Systemic Injection
• Hemocompatibility (Thromboresistance, Complement Activation, Platelet/Leukocyte Count, PTT, Hemolysis)
• Genotoxicity (Ames Assay, Mouse Lymphoma Assay, Mouse Micronucleus Assay)
• Pyrogenicity: Material Mediated Pyrogen | Compliance with ISO 10993 standards and FDA guidance | "The Subject Device was determined to be biocompatible." |
  | Sterility | Sterility testing | Compliance with ISO 11135-1:20007 and ISO 11135-2:2008 | "Sterility testing demonstrated that the device is compliant..." |
  | Animal Testing (GLP) | Safety, performance, and handling evaluation in porcine models | "safety acceptance criteria" (details not provided) | "the safety acceptance criteria for the studies were met." |
  | Pre-Clinical Cadaveric | Sheath insertion test on excised cadaveric carotid artery | "acceptability of the Dilator to Sheath transitions" | "All insertions were rated as acceptable by an experienced Vascular Radiologist. There was no evidence of damage to the test samples post insertions." |

2. Sample Size and Data Provenance (for test sets)

• Animal Testing (GLP): Three (3) porcine models were used. The data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective), but GLP (Good Laboratory Practice) implies a prospective, controlled study.
• Pre-Clinical Cadaveric Testing: The number of cadaveric carotid arteries used is not specified.

3. Number of Experts to Establish Ground Truth and Qualifications

• Pre-Clinical Cadaveric Testing: "an experienced Vascular Radiologist" performed the evaluation. The exact number of radiologists is not specified, but the phrasing "an experienced Vascular Radiologist" suggests one primary expert. Their years of experience are not quantified.

4. Adjudication Method

• The document does not describe a formal adjudication method (like 2+1 or 3+1) for any of its tests. Evaluations appear to be based on direct assessment against criteria or expert opinion without a multi-reader consensus process for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was performed or reported. The study design focuses on testing device function, biocompatibility, and safety, not on comparing human reader performance with and without AI assistance. The device itself is not described as an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only) Performance Study

• This device is a physical medical device (Transcarotid Neuroprotection System), not an algorithm or AI. Therefore, the concept of a "standalone algorithm only" performance study is not applicable. The performance studies described evaluate the physical device's function.

7. Type of Ground Truth Used

• Performance Testing: Ground truth is against predefined engineering specifications and international standards (e.g., ISO, FDA guidance).
• Biocompatibility Testing: Ground truth is against established biological response criteria outlined in ISO 10993 and FDA guidance.
• Animal Testing: Ground truth is based on gross pathology, clinical pathology results, and clinical observations of safety, performance, and handling.
• Pre-Clinical Cadaveric Testing: Ground truth is based on the expert assessment by a Vascular Radiologist regarding the acceptability of sheath insertions and absence of damage.

8. Sample Size for Training Set

• This document describes pre-market testing for a physical medical device, not an AI/ML algorithm. Therefore, the concept of a 'training set' in the context of machine learning is not applicable here.

9. How Ground Truth for Training Set was Established

• Not applicable as this is not an AI/ML device.

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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.

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