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The FilterWire EZ Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

The Boston Scientific FilterWire EZ Embolic Protection System is a temporary intra-vascular 0.014" guide wire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a protection wire in 190 and 300 cm lengths, an EZ Delivery Sheath, an EZ Soft Tip Retrieval Sheath and accessories. A separately packaged EZ Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire EZ protection wire. The 190 cm wire is compatible with the Boston Scientific extension wire (K970376 cleared June 6, 1997) for over-the-wire catheter exchanges.

The FilterWire EZ protection wire is delivered through a low profile delivery sheath, which allows free rotational movement of the guide wire component. The tip of the protection wire and the filter loop are radiopaque. The filter is deployed distal to the lesion, and the delivery sheath removed, leaving only the filter and filter loop at the end of a standard 0.014" guide wire. Interventional devices, which are 0.014" guide wire compatible, may then be tracked over the FilterWire guide wire to treat the lesion.

After treating the lesion, all interventional devices are removed, and a retrieval sheath is advanced to collapse the filter loop, trapping any emboli caught during the procedure. The retrieval sheath and FilterWire are then removed from the patient simultaneously.

Here's a breakdown of the acceptance criteria and the study details for the Boston Scientific FilterWire EZ Embolic Protection System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FilterWire EZ Embolic Protection System are not explicitly stated as numerical targets in a table. Instead, the document frames the acceptance based on a comparison to a predicate device (FilterWire EX) and favorable clinical outcomes. The primary measure of success and performance is the Major Adverse Cardiac Events (MACE) rate at 30 days.

2. Sample Size for Test Set and Data Provenance

• Sample Size (Clinical Test Set): 90 registry patients
• Data Provenance: Prospective, multi-center, non-randomized study (BLAZE). Data was pooled from 16 U.S. sites and 6 European sites.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts, their qualifications, or their role in establishing ground truth for the clinical study (BLAZE). Clinical outcomes (MACE, TIMI flow, device/clinical success) are typically determined by treating physicians and reviewed by a Clinical Events Committee, but these details are not provided in this summary.

4. Adjudication Method for Test Set

The document does not explicitly state the adjudication method used for clinical events in the BLAZE study.

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

No. This document describes studies for a medical device (embolic protection system), not an AI algorithm for image interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a medical device, not an AI algorithm.

7. Type of Ground Truth Used

For the clinical study (BLAZE), the "ground truth" was based on:

• Clinical Outcomes Data: Primarily Major Adverse Cardiac Events (MACE) at 30 days post-procedure, as well as secondary endpoints like MACE during index hospitalization, device success, clinical success, and final TIMI flow. These are patient-level clinical events and physiological measurements.
• Angiographic Variables: Baseline and final QCA (Quantitative Coronary Angiography) are mentioned, which provide objective measurements of vessel characteristics.

8. Sample Size for Training Set

Not applicable. This is a medical device, not an AI algorithm that requires a training set. The "training" or development involved non-clinical in-vitro and in-vivo animal model testing to refine the device design.

9. How Ground Truth for Training Set Was Established

Not applicable, as there's no "training set" in the AI sense. For the non-clinical development and testing of the device, the "ground truth" against which the device performance was evaluated would have been based on:

• Engineering Specifications: Dimensional tolerances, tensile strength, torque limits, etc.
• Biocompatibility Standards: Established biological safety requirements.
• Functional Performance Requirements: E.g., filter deployment, capture efficiency (though specific metrics are not detailed in this summary).
• Animal Model Outcomes: Safety and performance in animal models are evaluated against physiological parameters and pathological findings.

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The FilterWire EX Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/ debris) while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.5 to 5.5 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature.

The Boston Scientific FilterWire EX™ Embolic Protection System is a temporary intra-vascular 0.014" guidewire filtration system that is placed distal to the vessel lesion to be treated by interventional procedures. The system consists of a protection wire in 190 and 300 cm lengths, an EX Delivery Sheath, an EX Soft Tip Retrieval Sheath and accessories. A separately packaged EX Bent Tip Retrieval Sheath will also be available as an alternate tool for retrieving the FilterWire protection wire. When deployed, the protection wire's filter bag is designed to capture and recover emboli that may be produced during the angioplasty/stenting procedure while allowing blood flow to continue. Once deployed, the protection wire is used as a standard 0.014" steerable guidewire.

This 510(k) summary describes a medical device, not an AI/ML device, so many of the requested criteria regarding AI-specific studies (training/test sets, ground truth establishment, MRMC studies, standalone performance) are not applicable. However, I can extract the information relevant to the device's acceptance criteria and the studies performed.

Here's the analysis based on the provided text for the Boston Scientific FilterWire EX™ Embolic Protection System:

1. Table of Acceptance Criteria and Reported Device Performance

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

• FilterWire EX vs. No Protection Cohort:
  • Test set (FilterWire EX): 110 patients
  • Control (No Protection): 103 patients
• FilterWire EX vs. Predicate Device Cohort:
  • Test set (FilterWire EX): 332 patients
  • Control (Medtronic® AVE PercuSurge GuardWire Plus®): 319 patients
• Total Clinical Study Participants: 864 saphenous vein graft subjects.
• Data Provenance: The study was a randomized clinical trial, indicating it was prospective. The country of origin is not explicitly stated, but given the submission is to the US FDA by a US-based company, it's highly likely to include US data, possibly with international sites.

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

This is not applicable to this type of device submission. The "ground truth" for clinical outcomes (MACE, death, MI, revascularization) is established through medical records and clinical assessment by treating physicians and study investigators, not by a separate panel of experts creating a labeled dataset in the way it's done for AI/ML algorithms.

4. Adjudication Method for the Test Set

The document does not explicitly state the adjudication method for clinical events (like MACE). In randomized clinical trials, clinical events are typically adjudicated by an independent Clinical Events Committee (CEC) composed of medical professionals (e.g., cardiologists, neurologists) to ensure consistent and unbiased endpoint reporting. However, this specific detail is not provided in the summary.

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 a medical device (embolic protection system), not an AI/ML diagnostic or assistive tool.

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

Not applicable, as this is not an AI/ML algorithm.

7. The Type of Ground Truth Used

For the clinical studies, the "ground truth" was clinical outcomes data (e.g., 30-day rates of major adverse cardiac events (MACE) including death, myocardial infarction, emergent coronary artery bypass grafting, or repeat target vessel revascularization). This data is derived from direct patient observation and medical records, not from expert consensus on images or pathology.

8. The Sample Size for the Training Set

Not applicable. This is a hardware medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable, as there is no AI/ML training set.

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