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The FilterWire EZ™ 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 coronary saphenous vein bypass grafts and carotid arteries. The diameter of the vessel at the site of filter loop placement should be between 2.25 mm and 5.5 mm for coronary saphenous vein bypass graft procedures and between 3.5 mm and 5.5 mm for carotid procedures.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral vasculature, peripheral vessels other than carotid arteries, or in treating native coronaries, including acute myocardial infarction.

The Boston Scientific FilterWire EZ System (3.5 mm - 5.5 mm) 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, an EZ Delivery Sheath, an EZ Soft Tip Retrieval Sheath and accessories. A separately packaged EZ Bent Tip Retrieval Sheath is also 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 overthe-wire catheter exchanges.

The FilterWire EZ System is delivered via the EZ Delivery Sheath. Once the Protection Wire is across the lesion, the filter bag is expanded in the artery lumen by removing the EZ Delivery Sheath. After treating the lesion, all interventional devices are removed, and the EZ Soft Tip Retrieval Sheath or EZ Bent Tip Retrieval Sheath is advanced to the proximal end of the filter and the filter loop is retracted into the EZ Retrieval Sheath, trapping any emboli caught during the procedure. The EZ Retrieval Sheath and Protection Wire are then removed from the patient simultaneously.

This document describes the Boston Scientific FilterWire EZ™ Embolic Protection System.

Acceptance Criteria and Device Performance

Due to the nature of the device (a physical medical device for embolic protection), the provided 510(k) summary does not contain specific quantitative acceptance criteria or detailed device performance metrics in the format of a typical AI/software device. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through various tests and a clinical trial.

Summary of Device Performance and Verification:

Note on Quantitative Data: The provided text does not offer numerical percentages, sensitivities, specificities, or other quantitative performance data often associated with acceptance criteria for AI/software devices. The "acceptance criteria" for this physical device are implicitly met by passing various engineering, biological, and clinical studies to demonstrate substantial equivalence to legally marketed predicate devices.

Study Information

The primary clinical evidence referenced is the CABERNET Trial.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated in this 510(k) summary. The document mentions the CABERNET Trial's results were used to support the NexStent PMA (P050025). To obtain the exact sample size, one would need to refer to the PMA for the NexStent Carotid Stent.
   • Data Provenance: The study was a "carotid artery stenting clinical trial (CABERNET) sponsored by EndoTex™ Interventional Systems, Inc." This indicates it was a prospective clinical trial, likely involving multiple sites (though not explicitly stated) and would have predominantly included data from the country/countries where the trial was conducted. The specific country of origin is not mentioned.

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

   • This information is not provided in the 510(k) summary. For a clinical trial of a physical device, "ground truth" would typically be established through clinical outcomes, imaging assessments adjudicated by a clinical events committee (CEC), or other objective medical findings, rather than expert consensus on interpretive data (as would be common for AI/diagnostic software).

3. Adjudication method for the test set:

   • This information is not explicitly stated in the 510(k) summary. Clinical trials often employ a Clinical Events Committee (CEC) for endpoint adjudication, where multiple experts review cases. However, the specific method (e.g., 2+1, 3+1) is not detailed here.

4. 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, an MRMC comparative effectiveness study was not done. This device is a physical medical device (embolic protection system), not an AI-based diagnostic or assistive software. Therefore, the concept of "human readers improve with AI vs. without AI assistance" is not applicable.

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

   • Not applicable. This is a physical medical device, not an algorithm or software requiring a standalone performance evaluation.

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

   • For a clinical trial evaluating the safety and effectiveness of an embolic protection system, the "ground truth" would primarily be clinical outcomes data, such as rates of stroke, death, myocardial infarction, and other adverse events, as well as procedural success and device-related complications. Imaging data (e.g., degree of revascularization, evidence of embolization) would also contribute.

7. The sample size for the training set:

   • Not applicable. This device is a physical medical device undergoing a clinical trial for safety and effectiveness, not a machine learning model that requires a training set. The "in-vitro testing," "in-vivo testing," and "clinical evaluation" serve to validate the physical device.

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

   • Not applicable. As a physical device, there is no "training set" in the context of machine learning.

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The FilterWire EZ 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 coronary saphenous vein bypass grafts. The diameter of the artery at the site of filter loop placement should be between 2.25 mm and 5.5 mm.

The safety and effectiveness of this device as an embolic protection system has not been established in cerebral, carotid and peripheral vasculature or in treating native coronaries, including acute myocardial infarction.

The subject FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) consists of the same four main components as the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984. These components are:

• · A Protection Wire (0.014 in. [0.36 mm] guide wire and integrated filter loop) that incorporates a circular/oval-shaped structure (filter loop assembly), which supports a thin, porous, filter membrane designed to contain and remove embolic material while maintaining blood flow.
• · An EZ Delivery Sheath, a low-profile sheath that constrains the filter on the protection wire for delivery to the site of filter loop placement. It is prepackaged with the protection wire for coaxial delivery and has a slit for easy removal in a peel-away fashion.
• · An EZ Retrieval Sheath is intended to negotiate through the anatomy over the protection wire to retrieve the filter. The sheath is designed to track easily to the filter without catching on obstacles such as stents. The sheath has a radiopaque marker and is silicone coated.
• · A tool kit containing one peel-away introducer, one wire torquer and one hemostasis valve dilator

This is a 510(k) premarket notification for a medical device, the Boston Scientific FilterWire EZ Embolic Protection System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials with defined acceptance criteria for a new AI/software device.

Therefore, the requested information about acceptance criteria, study details, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance metrics are not applicable to this regulatory document.

The document states that the new device is substantially equivalent to a previously cleared device (K051984) and that "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use." However, it does not provide specific acceptance criteria or detailed study results in the format requested for an AI/software device.

Here's an attempt to structure the available information, noting the inapplicability of many requested fields:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of this 510(k) submission for a non-software medical device. The submission focuses on demonstrating substantial equivalence to a predicate device and meeting "design-input criteria" through non-clinical testing. Specific quantitative acceptance criteria and performance metrics for the device's function (e.g., filter efficiency, guidewire flexibility) are not detailed in this summary.

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

Not applicable as this is not an AI/software device requiring a test set of data. Non-clinical (in-vitro and in-vivo) testing was performed, but specific sample sizes for these tests are not provided in this summary.

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

Not applicable. This device is not an AI/software system that uses ground truth labels established by experts on a test set.

4. Adjudication Method for the Test Set

Not applicable.

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

No. This is not an AI/software device, so an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance Study?

No. This is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

Not applicable.

8. Sample Size for the Training Set

Not applicable. This device does not involve a training set as it's not an AI/software device.

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

Not applicable.

Summary of Relevant Information from the Document:

While the specific details requested for an AI/software device are not present, the document provides the following:

• Device: Boston Scientific FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm)
• Purpose of Submission: To demonstrate substantial equivalence to a predicate device (FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) cleared under K051984).
• Performance Evaluation: "Non-clinical tests conducted for the FilterWire EZ Embolic Protection System (2.25 mm - 3.5 mm) showed the device met its design-input criteria, and is safe and effective for its intended use."
• Testing Types Mentioned: In-vitro testing, in-vivo testing, biocompatibility, and packaging.
• Compliance: Where appropriate, testing conformed to the requirements of 21 CFR Part 58, Good Laboratory Practices (GLP).

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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.

I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Boston Scientific FilterWire EZ Embolic Protection System, primarily describing the device, its intended use, and its substantial equivalence to a predicate device.

It details:

• Device Description: What the FilterWire EZ Embolic Protection System is and how it functions.
• Intended Use: The specific medical procedures and patient populations for which the device is indicated.
• Labeling Changes: Minor updates to contraindications.
• FDA Communication: The FDA's determination of substantial equivalence for market clearance.

However, it does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study proving it meets acceptance criteria.
• Information on sample sizes for test sets or training sets.
• Data provenance, expert qualifications, adjudication methods, or MRMC studies.
• Standalone algorithm performance or the type of ground truth used.

Therefore, I cannot provide the requested information based on the text provided.

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