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The ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is intended for percutaneous transluminal angioplasty and post-dilatation of self-expanding stents in the carotid arteries.

The Silk Road Medical ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter is a standard rapid exchange (RX) 0.014" Percutaneous Transluminal Angioplasty (PTA) catheter with a proximal single lumen and distal coaxial lumen tubing with a dilatation balloon, and an atraumatic, tapered tip. The proximal luer lock hub allows for connection with a balloon inflation device for inflation with diluted contrast medium. The second lumen in the distal shaft permits the use of an 0.014" guidewire to facilitate advancement of the catheter to and through the stenosis to be dilated. The balloon has two radiopaque marker bands to aid in positioning the balloon in the stenosis, located either 25 or 35 mm apart as indicated on the package label. An external position marker is located 32.5 cm from the distal tip to indicate the relative position of the catheter tip to the guiding catheter/introducer sheath. The total working length of the catheter is 75 cm. The Silk Road Medical ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter will complement the TCAR procedure.

The provided text describes a medical device called the ENROUTE Enflate™ Transcarotid RX Balloon Dilatation Catheter and its substantial equivalence submission to the FDA. The document outlines acceptance criteria and the studies conducted to prove the device meets these criteria.

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

1. A table of acceptance criteria and the reported device performance

The document details various tests performed and states that the device "met all established requirements" and "all tests passed successfully." While specific quantitative acceptance criteria or exact performance values are not explicitly listed in a comparative table within the provided text, the document indicates that the device met the pre-determined acceptance criteria for each test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The text does not specify the sample sizes used for the test sets in any of the biocompatibility, design verification, sterilization, packaging validation, or shelf life studies. It also does not provide information about the country of origin or whether the data was retrospective or prospective, as these were all bench-top and lab-based tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The studies conducted (biocompatibility, bench-top engineering tests, sterilization/packaging validation) do not involve expert interpretation or ground truth establishment in the way clinical studies or image analysis algorithms would. The "ground truth" for these tests is based on established scientific and engineering principles, and validated test methods.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are typically relevant for clinical studies or studies involving human readers/interpreters, which is not the nature of the tests described for this device.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor any evaluation of human reader improvement with or without AI assistance. This device is a physical medical device (balloon dilatation catheter), not an AI-powered diagnostic or assistive tool.

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

This information is not applicable. The device is a physical medical device, not an algorithm. Therefore, "standalone" algorithm-only performance is not relevant to this submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed is based on established scientific principles, consensus standards (e.g., ISO, FDA guidance documents), and engineering specifications. For biocompatibility, it's the biological response to materials; for design verification, it's the physical and mechanical performance characteristics against predefined specifications; for sterilization, it's the efficacy of the sterilization process according to standards. It is not expert consensus, pathology, or outcomes data in the clinical sense.

8. The sample size for the training set

This information is not applicable and not provided. The development and testing of this physical medical device do not involve "training sets" in the context of machine learning or AI. The design and manufacturing processes are validated against specifications and standards, not "trained" on data.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated in point 8.

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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.

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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