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For use in Angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

The Trailrunner™ Guidewire is comprised of a PTFE coated stainless steel proximal core body and a Nitinol distal core body, joined by a Nitinol hypotube. The distal Nitinol core is inserted into the inside diameter of two adjacent, coaxial coils: a platinum coil (distal) and a stainless steel coil (proximal). A stainless steel flat wire (ribbon) is also inserted into the inside diameter of the coils. At the proximal extent of the stainless steel coil, a solder joint binds the coil to the Nitinol core and the flat wire. A second solder joint binds both coils at their junction; the core, and the SS ribbon together, A third solder joint at the distal tip of the device bonds the ribbon to the platinum coil. Depth markings using white PTFE are applied to the proximal end of the core. The distal tip of the guidewire is coated with hydrophilic coating. The 185cm version is designed to mate with the Lake Region extension wire cleared with other Lake Region Guidewires(Reference 510(k);s K970376, K041624)

The provided text describes a 510(k) submission for the TRAILRUNNER™ Guidewires, seeking substantial equivalence to a predicate device. This type of submission does not involve clinical trials with acceptance criteria for device performance in the same way a de novo or PMA submission might. Instead, substantial equivalence is demonstrated through non-clinical testing and comparison to a legally marketed predicate device.

Here's an analysis based on the information provided, specifically addressing the points in your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in terms of specific performance metrics with numerical values (e.g., sensitivity, specificity, accuracy) that would be common for AI/ML devices or diagnostics. Instead, the acceptance criterion for this 510(k) is substantial equivalence to the predicate device, the GUIDANT High Torque BMW Guidewire (K983033).

The "reported device performance" is described qualitatively as:

2. Sample Size for the Test Set and Data Provenance

• Sample Size: Not explicitly stated as a separate "test set" for performance evaluation in the context of clinical outcomes. The non-clinical testing involved "test pieces" for visual/tactile, dimensional, and mechanical attributes. The number of these test pieces is not quantified here.
• Data Provenance: Not applicable in the sense of patient data provenance (e.g., country of origin, retrospective/prospective). This is a physical medical device and the "data" would be from lab-based non-clinical tests.

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

• Number of Experts: Not applicable. For this type of 510(k) substantial equivalence submission, ground truth is established through engineering specifications, material properties, and physical performance testing against established standards or internal benchmarks, rather than expert clinical consensus on patient data.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Test results for physical and mechanical properties are typically objective measurements, not subject to expert adjudication of subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices or AI-assisted diagnostic tools where human reader performance is a key metric. This submission is for a physical medical guide wire.

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

• Standalone Performance: Not applicable. This is not an AI/ML algorithm or a diagnostic device. The performance is intrinsically linked to its physical interaction during a medical procedure, but its evaluation for this submission is based on non-clinical engineering and material properties.

7. The Type of Ground Truth Used

• Ground Truth Type:
  • Engineering Specifications and Design Documents: The core "ground truth" for the device's design and materials.
  • Predicate Device Characteristics: The established design, materials, and (presumably) validated performance of the legally marketed predicate device served as the primary reference for comparison.
  • ISO Standards (e.g., ISO 10993 for biocompatibility): These provide the ground truth for safety aspects like biocompatibility.
  • Established Test Methods and Performance Requirements: For mechanical and functional tests, the ground truth is the expected performance based on relevant engineering principles and industry norms for such guidewires.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set.

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The BridgePoint Medical Entera guidewires are intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PCTA) and percutaneous transluminal angioplasty (PTA). The Entera guidewires are not to be used in cerebral blood vessels.

The Entera is a conventionally constructed 0.014" diameter single use disposable guidewire that consists of a full length stainless steel shaft with proximal PTFE coating where the distal portion of the shaft is taper ground to provide distal flexibility. The distal portion also includes coaxially positioned coils, constructed of stainless steel and Pt/W for visibly under fluoroscopy. The coils are fixed to the stainless core via silver alloy solder and are optionally coated with silicone (Lake Region Medical MDX). The distal tip of the guidewire is supplied in a straight or angled geometry which transitions to a conventional rounded tip. A short extension with an approximate diameter of 0.0032" (which is a monolithic extension of the core wire) extends approximately 0.007" distal of the Entera rounded tip.

This document is a 510(k) summary for a medical device called the BridgePoint Medical Entera™ Percutaneous Coronary and Peripheral Guidewire. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study. Therefore, the information typically requested in your prompt regarding acceptance criteria and detailed study results is generally not present in this type of regulatory submission.

Specifically, the document does not contain any information about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for a test set, data provenance, or details of a study proving the device meets acceptance criteria.
3. Number of experts, their qualifications, or adjudication methods for ground truth because no such study addressing acceptance criteria is described.
4. A multi-reader multi-case (MRMC) comparative effectiveness study, nor effects of AI assistance.
5. Standalone algorithm performance, as this is a physical medical device, not an AI algorithm.
6. The type of ground truth used, as no study requiring ground truth is detailed for performance assessment.
7. Sample size for a training set or how ground truth was established for a training set, as these concepts relate to AI/ML models, which this device is not.

The document states that the BridgePoint Medical Entera™ Guidewire is "substantially equivalent" to existing predicate devices (Lake Region PTCA guidewire/Triumph, Cordis/Brivant, Ltd. Regatta Steerable Guidewire, and Asahi PTCA Guidewire Confianza Pro). The arguments for substantial equivalence are based on:

• Intended Use: All devices are designed to facilitate placement of balloon dilatation catheters or other intravascular devices during PTCA/PTA.
• Method of Operation: The Entera is a conventionally constructed guidewire.
• Technical Aspects:
  • It is a 0.014" diameter single-use disposable guidewire with a full-length stainless steel shaft, proximal PTFE coating, and a taper-ground distal portion for flexibility.
  • The distal portion includes coaxially positioned coils of stainless steel and Pt/W for fluoroscopic visibility.
  • The coils are fixed via silver alloy solder and can be silicone-coated.
  • The distal tip can be straight or angled, transitioning to a rounded tip.
  • Key difference and justification for equivalence: The Entera has a 0.0032" diameter, 0.007" long narrowed extension on its distal tip, unlike the standard 0.014" distal tip of the Triumph. However, this narrowed tip is stated to be "substantially equivalent" to the narrowed distal tip geometries of the Cordis Regatta (which has a non-conventional "wedge shaped" tip substantially less than 0.014") and the Asahi Confianza Pro (which tapers to 0.009" diameter).
  • The distal-most portion of the Entera core wire (under the distal coil) has a round cross-section, while the Triumph has a flattened/ribbon cross-section.
  • The Entera and Triumph are manufactured by the same company (Lake Region Medical) and use the same component materials with "very similar physical attributes (flexibility, radiopacity, etc.)."

In summary, this document is a regulatory submission demonstrating substantial equivalence, not a study designed to explicitly meet predefined performance acceptance criteria.

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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 EZTM 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 vessel 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 the cerebral, carotid, or peripheral vasculature.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating patients with acute myocardial infarction.
• The safety and effectiveness of the device as an embolic protection system has not been established in treating native coronaries.

The Boston Scientific FilterWire EZ (2.25 mm - 3.5 mm) 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 (190 cm or 300 cm length), an EZ Delivery Sheath, an EZ Retrieval Sheath and accessories. The 190 cm long wire is compatible with the Boston Scientific Add Wire® Extension Wire (K970376 cleared June 6, 1997) for over-the-wire catheter exchanges. The Filter Wire EZ (2.25 mm - 3.5 mm) Protection Wire 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 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 EZ Protection Wire are then removed from the patient simultaneously.

This document is a 510(k) premarket notification for the Boston Scientific FilterWire EZ™ Embolic Protection System (2.25 mm – 3.5 mm). The study described is not for an AI/ML device, but rather a traditional medical device. Therefore, much of the requested information (e.g., number of experts, adjudication methods, MRMC study, standalone performance, training set details) is not applicable.

However, based on the provided text, here is an analysis of the acceptance criteria and study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The primary acceptance criterion for the clinical study was likely to demonstrate non-inferiority in the 30-day MACE rate compared to the predicate GuardWire Plus device in the specified vessel diameter range.

2. Sample Size and Data Provenance

• Test Set (Clinical Study):
  • FilterWire EZ Group (BLAZE II): 131 registry patients, 8 roll-in patients, 1 compassionate use patient (total 140 enrolled, but performance analysis focuses on "131 registry patients").
  • GuardWire Plus Control Group (FIRE Trial subset): 169 patients treated within the 2.25 mm - 3.5 mm vessel diameter range.
• Data Provenance: Prospective, multi-center study (BLAZE II) for the FilterWire EZ device. The comparator data (GuardWire Plus) was from a subset of a previously completed study (FIRE Trial). The countries of origin of the data are not explicitly stated, but it's a multi-center study.

3. Number of Experts and Qualifications

This information is not applicable as the submission describes a traditional medical device with a clinical trial, not an AI/ML device where expert consensus is typically used to establish ground truth for a test set.

4. Adjudication Method

This information is not applicable for a traditional clinical trial measuring clinical outcomes like MACE. MACE (Major Adverse Cardiac Events) are defined clinical endpoints.

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

• Not Applicable. This is a study for a traditional medical device (embolic protection system), not an AI/ML diagnostic or assistive device that would involve human readers.

6. Standalone Performance

• Not Applicable. This device is an interventional tool, and its performance is inherently linked to human use during a procedure. "Standalone performance" as often understood for AI algorithms (i.e., algorithm only without human-in-the-loop) is not relevant here. However, the study focuses on the device's technical success, clinical success, and impact on patient outcomes (MACE) when used by clinicians.

7. Type of Ground Truth Used

• Clinical Outcomes Data: The primary ground truth for the clinical study was the occurrence of Major Adverse Cardiac Events (MACE) at 30 days post-procedure, as well as device success, clinical success, and final TIMI 3 flow. MACE is a composite of clinically defined adverse events (e.g., all-cause death, myocardial infarction, target vessel revascularization). The presence of non-Q wave MI was assessed via CK-MB levels.

8. Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device that requires a "training set" in the context of machine learning. The device design and specifications are based on engineering principles and preclinical testing.

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

• Not Applicable. See point 8.

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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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