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The EmPro™ EPS/Nanoparasol™ EPS is indicated for use as a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the filter placement should be between 3.0 and 6.5 mm.

MicroVention's Embolic Protection System (EPS) is marketed under two names: EmPro™ Embolic Protection System and Nanoparasol™ Embolic Protection System. The Embolic Protection System (EPS) is designed to capture and remove dislodged debris during a carotid interventional procedure. It consists of three basic components and additional accessories:

1. An Embolic Protection Device (EPD) consisting of a nitinol braided mesh filter with an atraumatic distal tip built on an integrated .014" PTFE coated stainless steel capture delivery wire.
2. A 3.5F delivery catheter with 150 cm length.
3. A 5F retrieval catheter with 150 cm working length. Accessories include a wire introducer, EPD loading cover, sheath introducer and a torque device. Catheters are provided in two separate dispenser coils.

The provided text describes the acceptance criteria and the study proving the device meets these criteria for the EmPro™ EPS/Nanoparasol™ EPS. This device is an embolic protection system indicated for use as a guidewire to contain and remove embolic material during angioplasty and stenting procedures in carotid arteries.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Clinical Study (Test Set): 256 patients (n=256) in the Intent-To-Treat (ITT) population.
• Data Provenance: The study was a "multicenter, single-arm, interventional study" called the CONFIDENCE study (IDE G140249). While the specific countries are not mentioned, FDA submissions typically involve studies conducted in the US or under equivalent international standards. The study design is prospective.
• Sample Size for Animal Study: 6 animals (porcine model).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical study's endpoint definitions (MAE, technical success). Clinical trials typically involve a clinical events committee (CEC) composed of expert physicians to independently adjudicate events like death, stroke, and MI, but this level of detail is not provided in this regulatory summary.

For the animal study, the document mentions "histological analysis" and "neurological assessments" were performed, implying expert evaluation, but the number and specific qualifications of the experts are not detailed.

4. Adjudication method for the test set

The document does not explicitly detail an adjudication method (e.g., 2+1, 3+1) for the clinical study's primary and secondary endpoints. For a multi-center clinical study with composite endpoints like MAE, it is standard practice to have a Clinical Events Committee (CEC) adjudicate events, often with multiple readers and a pre-defined adjudication process, but the specifics are not provided here.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an embolic protection system, not an AI-powered diagnostic tool, so such a study would not be applicable. The performance evaluated relates to the mechanical and clinical outcomes of the device itself and its ability to capture emboli, not human reader performance with or without AI assistance.

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. This device is a physical medical device (an embolic protection system), not an algorithm or AI system. Its performance is evaluated in vivo (animal and human clinical studies) and in vitro (bench testing), not as a standalone algorithm.

7. The type of ground truth used

• Clinical Study (CONFIDENCE study): The ground truth for the primary endpoint (MAE) was based on clinical outcomes: death, stroke, and myocardial infarction (MI), confirmed by medical records and follow-up. For secondary endpoints like technical success (e.g., EPS successfully inserted, deployed, retrieved), the ground truth would be based on procedural observations and documentation. This represents outcomes data and procedural success data.
• Animal Study: Ground truth was established through direct observation during intervention (e.g., tracking, deployment, retrieval), post-intervention assessment (thrombus formation, particulate capture, device damage, neurological dysfunction), and post-explantation histopathology/histology to evaluate tissue response.

8. The sample size for the training set

This document does not describe a "training set" in the context of an AI/ML model. The studies described are for the validation and performance evaluation of a physical medical device. Therefore, a training set sample size, as understood in AI/ML development, is not applicable or provided.

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

As there is no mention of a "training set" for an AI/ML model, this question is not applicable. The device's design and engineering would have been informed by a vast amount of existing medical knowledge, material science, and prior device development, rather than a specific "training set" with established ground truth in the AI/ML sense.

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The 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 appropriate anatomy described below:

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

The ENROUTE® Transcarotid Neuroprotection System (Modified) is designed to provide direct transcarotid arterial access to the common carotid artery (CCA), provide introduction of diagnostic agents and therapeutic devices, and provide embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis. The ENROUTE Transcarotid NPS (Modified) 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.

The ENROUTE Transcarotid NPS (Modified) consists of four primary components: the Transcarotid Arterial Sheath with Dilator, the Venous Return Sheath with Dilator, the Flow Controller and a 0.035" Extra Support J-Tip Guidewire. When assembled and inserted into the patient, the components of the ENROUTE Transcarotid NPS (Modified) create an arteriovenous shunt. When used in conjunction with occlusion of the proximal common carotid artery, the ENROUTE Transcarotid NPS (Modified) reverses the direction of blood flow in the internal carotid artery (ICA), shunting embolic particles away from the cerebral circulation, and into the venous circulation. Flow through the arteriovenous shunt is regulated by the Flow Controller.

The provided text is a 510(k) summary for the ENROUTE® Transcarotid Neuroprotection System (Modified). It describes the device, its intended use, and the testing conducted to demonstrate its substantial equivalence to a predicate device. However, the document does not contain any information about a study involving an AI/Machine Learning device or human readers.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria for an AI device, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance.

The document entirely focuses on the substantial equivalence of a mechanical medical device (a catheter system) based on:

1. Biocompatibility testing: Ensuring materials are safe for patient contact.
2. Design Verification (Bench-Top Testing): Evaluating physical and mechanical properties.
3. Sterilization, Packaging Validation, and Shelf Life: Ensuring the device remains sterile and functional over time.

It explicitly states: "The subject, ENROUTE® Transcarotid Neuroprotection System (Modified) met all established requirements." but these requirements are related to the physical and biological performance of the mechanical device, not AI performance.

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ANGIOGUARD XP and ANGIOGUARD RX Emboli Capture Guidewire devices are indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing carotid artery angioplasty and stenting procedures in carotid arteries. The diameter of the site of filter basket placement should be from 3mm to 7.5mm.

Both the subject and predicate ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices consists of a guidewire with integrated emboli filter basket at the distal end. The devices function as an interventional guidewire and distal protection device during delivery and placement of stents and interventional devices in carotid procedures. The guidewire is delivered via an OTW (overthe-wire) or RX (rapid-exchange) deployment sheath and is captured via an OTW or RX capture sheath. The ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire devices have a filter basket at the distal end that is deployed prior to the stenting procedure. When deployed, the filter basket opens in an umbrella-like fashion, allowing passive hemo-filtration with subsequent emboli capture. At the end of the procedure, the filter is collapsed and retrieved.

The provided document is a 510(k) premarket notification decision letter from the FDA regarding the ANGIOGUARD XP Emboli Capture Guidewire and ANGIOGUARD RX Emboli Capture Guidewire. This document determines substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance related to a diagnostic or therapeutic algorithm.

Instead, it focuses on the substantial equivalence of an updated version of a medical device (the ANGIOGUARD XP/RX Emboli Capture Guidewire) to a previously cleared predicate device. The changes are limited to a material change for the Deployment and Capture Sheath components.

The "Performance Data" section (Page 4-5) lists the types of tests performed to demonstrate that the new material meets the same requirements as the previous material and that the device's performance and functionality remain substantially equivalent. However, these are not "acceptance criteria" in the sense of performance metrics for an AI algorithm or a diagnostic test with corresponding study results. They are engineering and biocompatibility tests to ensure the safety and effectiveness of the physical device after a material change.

Therefore, for the requested information:

1. A table of acceptance criteria and the reported device performance: Not available in the provided document in the context of a diagnostic or therapeutic performance study. The document focuses on showing that a material change to an existing device maintains equivalence to its predicate. The "performance data" listed are physical and biological tests, not performance metrics like sensitivity, specificity, etc., with associated target levels and results.

2. Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of an algorithm or diagnostic study. The tests mentioned (e.g., biocompatibility) involve laboratory samples or animal models, not human patient data in the way a diagnostic study would.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for a diagnostic test is described.

4. Adjudication method: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is a physical device, not an AI or diagnostic algorithm improving human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable.

8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is a physical device submission, not an AI algorithm submission.

9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA letter confirms the substantial equivalence of a physical medical device following a material change. It does not describe a study involving acceptance criteria for diagnostic/therapeutic performance, nor does it involve AI or algorithmic performance evaluation.

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The WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION® may be used with commercially available 0.014" guide wires.

WIRION® is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

I am sorry, but the provided text from the FDA 510(k) K210282 letter and summary for the WIRION® Embolic Protection System does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI-based or statistical classification system.

The document is a traditional 510(k) submission for a physical medical device (an embolic protection system), not a software or AI-driven diagnostic device that would typically involve acceptance criteria related to sensitivity, specificity, or reader studies.

The "Functional and Safety Testing" section mentions:

• Biocompatibility testing
• Simulated use
• Bond and torque strength testing
• Package testing

These are standard engineering and safety tests for a physical medical device, not performance metrics for an AI algorithm.

Therefore, I cannot extract the requested information (table of acceptance criteria, sample sizes, expert involvement, MRMC study details, etc.) from the provided text because it is not relevant to the type of device described in the document.

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The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a temporary Embolic Protection System (EPS), filtering distal to the intervention site. The system is a rapid exchange, pre-crimped filter that can be used with any commercially available 0.014" guide wires.

This document is for an embolic protection system (WIRION™), a medical device, and not an AI/ML powered device. Therefore, many of the requested criteria (e.g., acceptance criteria for an AI algorithm, expert ground truth establishment, MRMC study, training/test set sample sizes, data provenance) are not applicable to this 510(k) submission.

The core of this 510(k) submission is that the WIRION™ device is identical to a previously cleared predicate device (K180023). This means the manufacturer is asserting substantial equivalence based on the device being literally the same as one already on the market, rather than needing to prove performance through new clinical or algorithm-specific studies.

Here's how to address the request based on the provided document:

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

Since this is a substantial equivalence claim based on identity to a predicate device, there are no specific performance acceptance criteria or reported performance data for this specific submission. The acceptance is predicated on the prior clearance of the identical device.

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

• Not Applicable. No new test set or data provenance details are provided because the device is stated to be identical to a previously cleared predicate.

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)

• Not Applicable. No ground truth establishment by experts for a test set was required for this submission.

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

• Not Applicable. No adjudication method for a test set was required for this submission.

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

• Not Applicable. This is not an AI/ML device, and no MRMC comparative effectiveness study was performed or required.

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

• Not Applicable. This is not an algorithm, so no standalone performance evaluation was done.

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

• Not Applicable. No new ground truth types were used or established for this submission, as it relies on the predicate device's prior clearance. The previous clearance would have relied on data and performance demonstrations appropriate for a mechanical medical device, likely including preclinical testing and/or clinical data that established safety and effectiveness.

8. The sample size for the training set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. No ground truth for a "training set" was established.

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The Emboshield NAV Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries and while performing atherectomy, during standalone procedures or together with PTA and/or stenting, in lower extremity arteries. The diameter of the site of the Filtration Element should be between 2.5 and 7.0 mm.

The Emboshield NAVO Embolic Protection System (EPS) is a temporary percutaneous transluminal filtration system designed to capture embolic material released during interventional procedures within carotid arteries or atherectomy in the arterial vasculature of the lower extremity. The system consists of the following components: BareWire Filter Delivery Wire, RX Delivery Catheter, Filtration Element and RX Retrieval Catheter and ancillary items which include loading funnel, flushing syringes, introducer tool and torque devices.

Here's an analysis of the provided text, outlining the acceptance criteria and the study proving the device meets them, based on the requested categories.

Important Note: The provided text is a 510(k) summary for a medical device (Embolic Protection System), not an AI/ML device. Therefore, many of the requested categories related to AI model development, such as training sets, expert adjudication of ground truth, and MRMC studies, are not directly applicable or discussed in this document. The focus of this submission is on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and clinical data on safety and efficacy in an expanded indication for use.

Acceptance Criteria and Device Performance for Emboshield NAV6 Embolic Protection System (K191173)

1. Table of Acceptance Criteria and Reported Device Performance

• Deployment and Retrieval Force
• Simulated Use | The assessment concluded these tests should be performed, and the overall conclusion states the device met all acceptance criteria. (Specific pass/fail results for individual non-clinical tests are not detailed in this summary.) |
  | Technological Equivalence | Show substantial equivalence to predicate in:
• Intended Use
• System Components
• Technological Characteristics
• Sterilization
• Materials and Biocompatibility | "The conclusion of the comparison analysis is that the subject Emboshield NAV6 EPS is substantially equivalent to the predicate device." |
  | Safety - Filter Specific | Low occurrence of events directly reflecting filter performance (distal embolization, perforation at filter level, unplanned amputation) | One case of distal embolization, no cases of perforation at the level of the filter, and no unplanned amputations among MAEs. |
  | Overall Safety & Effectiveness | No new safety or effectiveness issues raised. | "The clinical and non-clinical data demonstrate that the subject Emboshield NAV6 EPS met all acceptance criteria and performed similarly to the predicate device and that no new safety or effectiveness issues were raised." |

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

• Sample Size for Clinical Study: n=162 patients.
• Data Provenance: Retrospective clinical data from a "real-world population" of peripheral arterial disease (PAD) patients treated at the Mount Sinai Health Center (USA, implied by FDA submission context, though not explicitly stated as country of origin). The data represents routine clinical practice.

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

• This document does not describe the use of experts to establish a "ground truth" for the clinical test set in the way it would be for an AI/ML diagnostic device. The clinical outcomes (MAE) were observed clinical events, not interpretations by experts for the purpose of a ground truth.
• The MAE definition is a composite of clinical events (death, MI, thrombosis, dissection, distal embolization, perforation, unplanned amputation, TVR). These are typically determined by clinical observation and data collection according to study protocols, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

• Not applicable in the context of this device. The clinical events (MAE) are observed outcomes, not interpretations requiring adjudication.

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

• Not applicable. This is not an AI/ML device. The study evaluates the performance of a medical device (embolic protection system) in a clinical setting, not how human readers' diagnostic accuracy changes with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is not an AI/ML algorithm. The device's performance is measured in its intended use during a clinical procedure.

7. The Type of Ground Truth Used

• The "ground truth" for the clinical study was the occurrence or non-occurrence of predefined clinical events (Major Adverse Events - MAE) in real-world patients. This can be considered a form of "outcomes data."
• For non-clinical testing, the "ground truth" relies on predefined engineering specifications and simulated use outcomes.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/ML device or an algorithm that requires a "training set" in the machine learning sense. The clinical data was used to demonstrate the device's performance in a real-world setting.

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

• Not applicable, as there is no "training set" for this type of medical device submission.

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WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries.

The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.

The document describes the acceptance criteria and study findings for the WIRION™ Embolic Protection System (EPS).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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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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The RX ACCUNET Embolic Protection System is indicated for use as a guide wire and embolic protection system to contain and remove embolic material (thrombus / debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the site of filter basket placement should be between 3.25 mm and 7.0 mm.

The RX ACCUNET Embolic Protection System is a filtration type embolic protection device, filtering distal to the interventional site. The System consists of the RX ACCUNET™ Delivery System, the RX ACCUNET Recovery Catheter, Shapeable Tip Design and the RX ACCUNET 2 Recovery Catheter, Low-Profile, Flexible Tip Design all packaged together in one chipboard carton. The RX ACCUNET Embolic Protection System is delivered via a Delivery Sheath with a flexible tip coil that facilitates movement of the Sheath through tortuous anatomy. Once across the lesion, the Filter Basket is expanded in the arterial lumen by peeling the Delivery Sheath from the guide wire using the torque device and peel away adapter. At the conclusion of the interventional procedure, the Filter Basket is collapsed inside.one of the provided Recovery Catheters. Recovery Catheter selection is based on physician preference and/or patient anatomy. Once collapsed, the entire system is removed as a single unit. The Recovery Catheters have radiopaque tips to facilitate movement though tortuous anatomy. The change being made is to the formulation of an adhesive that is used to adhere two core subassemblies.

The provided text describes a 510(k) premarket notification for the RX ACCUNET Embolic Protection System and focuses on a change in adhesive formulation rather than a comprehensive study for initial device efficacy. Therefore, much of the requested information regarding clinical study design, ground truth, and reader studies is not present in this document.

However, based on the provided information, I can extract details about the acceptance criteria for the specific modification to this device and the study conducted to demonstrate that the device meets these criteria.

Acceptance Criteria and Reported Device Performance

Since this 510(k) is for a modification to an already cleared device, the study described here is focused on demonstrating that the modification (adhesive reformulation) does not adversely affect the device's performance compared to its predicate and that it remains safe. It is not a study to establish initial clinical efficacy or standalone performance against a clinical ground truth.

Here's what can be extracted and what information is not available:

1. A table of acceptance criteria and the reported device performance: (See table above)

2. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified in the document. The testing described is in vitro bench testing. Typically, in vitro tests don't involve "patients" or "data provenance" in the same way clinical studies do. The samples would be device units or components.
   • Data Provenance: Not applicable in the context of in vitro bench testing of device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not applicable/not provided because the described studies are in vitro bench tests (e.g., hypotube adhesion pull test), not clinical studies involving expert interpretation of medical data or images. The "ground truth" for a pull test is the physical outcome of the test (e.g., force at failure).

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

   • This information is not applicable/not provided as it pertains to expert consensus in clinical evaluations, which is not described here.

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:

   • This information is not applicable/not provided. The device is an Embolic Protection System, not an AI-powered diagnostic tool requiring human reader studies.

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

   • This information is not applicable/not provided. The device is a physical medical device (an Embolic Protection System), not a software algorithm.

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

   • For the in vitro bench testing, the "ground truth" would be the physical measurements and observations from the specific tests conducted (e.g., force measured in the hypotube adhesion pull test, laboratory results from biocompatibility assays). There is no clinical "ground truth" in this context.

8. The sample size for the training set:

   • This information is not applicable/not provided. This document describes the testing of a physical medical device modification, not the development or training of an AI algorithm.

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

   • This information is not applicable/not provided for the same reasons as point 8.

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The WIRION™ is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting procedures in carotid arteries.

The diameter of the vessel at the site of filter basket placement should be between 3.5 mm to 6.0 mm. WIRION™ may be used with commercially available 0.014" guide wires.

WIRION™ is a embolic protection System comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator.

Here's a breakdown of the acceptance criteria and the study details for the WIRION™ Embolic Protection System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document explicitly states that "All tests met their predetermined acceptance criteria," but it does not provide a specific table of these criteria. Instead, it details the observed performance of the primary and secondary endpoints in the clinical study.

Study Details:

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

• Sample Size: 120 patients
• Data Provenance: Clinical studies. The text does not explicitly state the country of origin but implies a multicenter study, and it mentions "historic control" which suggests a comparison to existing data from potentially various sources. The study was prospective, open label, and single arm.

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

The document does not provide details on the number or specific qualifications of experts used to establish ground truth for the clinical study. MACCE (Major Adverse Cardiac and Cerebrovascular Events) rates and other clinical endpoints are typically determined by clinical outcomes and adjudicated by study investigators or independent clinical events committees, but the specific structure is not described here.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method (e.g., 2+1, 3+1). Clinical trials typically use independent adjudication committees for primary endpoints like MACCE, but this detail is not provided.

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not conducted or mentioned. This device is an embolic protection system (a physical medical device), not an AI-powered diagnostic tool.

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

No, a standalone algorithm performance study was not done. This is a physical medical device. The performance refers to its function within the human body during a medical procedure, not an algorithm's output.

7. The Type of Ground Truth Used

The ground truth for the clinical study was based on outcomes data (MACCE rates, device success, clinical success, angiographic success, procedural success, complications) observed in human patients during the study.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. This is a physical medical device, not a software algorithm that would require a training set. The clinical study described involved 120 patients.

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

As there is no "training set" for an algorithm mentioned, this question is not applicable. For the clinical study, the ground truth was established by clinical observation and assessment of patient outcomes.

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