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The Mcdtronic Interceptor® PLUS Coronary Filter System is intended for use in saphenous vein bypass grafts, with a reference vessel diameter between 2.5 mm and 5.25mm, in conjunction with percutaneous transluminal coronary intervention (PTCI) for embolic particulate capture. The Interceptor® PLUS Coronary Filter System is intended for temporary use in conjunction with other therapeutic devices and is intended to be removed at the completion of the interventional procedure.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature

The Interceptor® PLUS Coronary Filter System (the Device) consists of six components; an 180cm extendable Steerable Vascular Filter, an Actuator Handle, a Torque Handle, a Guidewire Introducer, Peel Away Introducer and a RX Facilitator Catheter . The Steerable Vascular Filter is comprised of a radiopaque nitinol filter mounted near the distal tip of a steerable 0.014 inch nitinol hypotube guidewire. The guidewire extends 3.5cm beyond the distal end of the filter in the collapsed state to facilitate distal tracking and steering through tortuous vessels and tight lesions. The proximal end of the steerable vascular filter contains four large openings (Approximately 1400 microns for the 3.5mm filter, >1500 microns for the 4.5mm filter size and >1800 microns for the 5.5mm filter size) that allow embolic particulate to enter the filter.

In addition to the Interceptor® PLUS Coronary Filter System, there is an optional Angled RX Facilitator Catheter when an alternative tip configuration is desired for filter withdrawal.

The Medtronic Interceptor® PLUS Coronary Filter System's acceptance criteria and the study proving its performance are detailed below:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Original Analysis: 800 saphenous vein graft patients total (501 in Treatment arm, 247 in Control arm).
  • Adjusted Analysis (due to missing CK-MB data):
    • Interceptor PLUS (Treatment arm): 139 patients
    • Control arm: 82 patients
    • Additional data for estimating non-Q wave MI: 158 patients from SAFER study (GuardWire arm) and 178 patients from Amethyst study (Control arm) with non-missing CK-MB.
• Data Provenance: The study was a randomized clinical trial, implying prospective data collection. The document does not specify the country of origin, but given the FDA submission, it's likely a multi-center trial with sites possibly in the US.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information about the number of experts or their qualifications used to establish the ground truth for the test set. The ground truth (MACE) appears to be derived from clinical outcomes and laboratory results (CK-MB levels) which are typically assessed by physicians and laboratory personnel, rather than explicitly stated "experts" creating a ground truth set for an AI model.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set in the context of expert review. The primary endpoint, Major Adverse Cardiac Events (MACE), is a composite clinical outcome determined by predefined criteria (death, Q-wave or non-Q wave MI, emergent CABG, target vessel revascularization). The assessment of these components would follow standard clinical practice and laboratory interpretations, rather than a specific adjudication process for a test set in the way one would for an imaging AI study.

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

No. This study is a clinical trial assessing the effectiveness of a medical device (filter system) in human patients, not a study evaluating human readers' performance with or without AI assistance. Therefore, an MRMC comparative effectiveness study was not conducted, and no effect size for human readers' improvement with AI is reported.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Interceptor® PLUS Coronary Filter System is a physical medical device (embolic protection filter), not an algorithm or AI model. Therefore, a standalone (algorithm only) performance study was not conducted. The study evaluated the device's performance in preventing adverse cardiac events in patients.

7. Type of Ground Truth Used

The ground truth used was clinical outcomes data, specifically Major Adverse Cardiac Events (MACE), which is a composite endpoint defined by:

• Death
• Q-wave or non-Q wave MI (Myocardial Infarction), assessed via CK-MB results
• Emergent Coronary Artery Bypass Surgery (CABG)
• Target Vessel Revascularization (TVR) within 30 days.

8. Sample Size for the Training Set

Not applicable. This is a study of a physical medical device in a clinical trial, not an AI model. Therefore, there is no "training set" in the context of machine learning.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI model.

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The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm - 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.

The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction. The device is not intended to be used as a thrombectomy system.

The Proxis System (Proxis Embolic Protection System) is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter (Proxis Catheter), Inflation device, Aspiration syringe, Lip Seal and Strainer basket.

In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately) may be used with Proxis System.

In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. Upon completion of the interventional device procedure, fluid and particles from the procedure may be aspirated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to aspirate fluid and particles from the treatment site.

Here's a breakdown of the acceptance criteria and study information based on the provided text, using the structure you requested:

Acceptance Criteria and Device Performance

This 510(k) submission for the Proxis System is for a minor modification (material change in the occluding balloon) to an already cleared device. Therefore, the "acceptance criteria" are not reported as specific performance metrics in this summary, but rather as meeting all previously established verification specifications. The device did not undergo a new clinical trial for this specific submission because the changes were deemed non-significant.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is actually based on the previous clearances of the Proxis System (K060651 and K052523), not a new study for this specific submission (K073563).

1. Sample size used for the test set and the data provenance: No new clinical test set was used for this 510(k) submission. The decision was made that "no additional animal or clinical data was deemed necessary" due to the non-significant nature of the modification. The original test data would have come from the studies supporting K060651 and K052523, but details like sample size, country of origin, or retrospective/prospective nature are not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this submission as no new clinical test data was generated. For the predicate device clearances, this information is not available in the provided text.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this submission.

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: Not applicable. This device is a medical instrument (an embolic protection system), not an AI-based diagnostic or imaging device used by human readers.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable for this submission. For the predicate device clearances, this information is not available in the provided text, but it would presumably involve a combination of in-vitro testing, animal studies, and potentially clinical trial outcomes demonstrating safety and effectiveness in preventing embolization.

7. The sample size for the training set: Not applicable. This is not an AI/ML-based device that relies on a "training set."

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

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The SpiderFX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpiderFX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpiderFX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a 190 cm or a convertible 320/190 cm PTFE-coated 0.014" stainless steel guidewire and a dual-ended SpiderFX Catheter for delivery and recovery.

Acceptance Criteria and Device Performance for SpiderFXTM Embolic Protection Device

This document describes the acceptance criteria and study proving the device meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific quantatitive acceptance criteria for the SpiderFX™ device. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device. Therefore, the "acceptance criteria" can be inferred as achieving equivalence to the predicate device's performance in various tests.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document does not specify exact sample sizes for the "in vitro bench testing," "package integrity testing," or "in vivo animal studies." It only generally states that these tests were conducted.
• Data Provenance: The studies were non-clinical, involving in vitro bench testing and in vivo animal studies. The country of origin for the data is not specified, but the manufacturer is based in Plymouth, MN, USA. The data is implicitly prospective as it was generated to support the 510(k) submission.

3. Number and Qualifications of Experts for Ground Truth

• Number of Experts: This information is not provided in the text.
• Qualifications of Experts: This information is not provided in the text.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the test set. Since the studies were non-clinical bench and animal tests, the concept of expert adjudication as used in clinical imaging studies would not typically apply.

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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study in the provided text. The device is a physical medical device (embolic protection device), not an AI algorithm for diagnostic imaging that typically involves MRMC studies to assess human reader improvement.

6. Standalone (Algorithm Only) Performance Study

This question is not applicable as the SpiderFX™ Embolic Protection Device is a physical medical device, not a standalone algorithm.

7. Type of Ground Truth Used

For the non-clinical studies:

• In vitro bench testing: The ground truth would be based on physical and engineering measurements against predefined specifications or comparative performance with the predicate device.
• In vivo animal studies: The ground truth would be established through direct observation, animal physiological measurements, and potentially necropsy results to evaluate the device's ability to contain and remove embolic material, as well as its safety.

8. Sample Size for the Training Set

This question is not applicable. The SpiderFX™ Embolic Protection Device is a physical medical device. It does not employ machine learning or AI that would require a "training set" in the conventional sense. The development of the device would involve engineering design, prototyping, and iterative testing, not data-driven training of an algorithm.

9. How Ground Truth for the Training Set Was Established

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

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The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, System: TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable.

The balloon guidewire is advanced through the hospital-supplied 7F guide catheter (without sideholes) prior to percutaneous coronary intervention of a saphenous vein araft (SVG) and positioned just past the target lesion. The balloon is inflated with a medical grade carbon dioxide gas blend, creating a protected space between the quide catheter and the balloon. Once the balloon is inflated and vessel occlusion is confirmed, PTCA and/or stenting can be performed over the balloon guidewire. Immediately after intervention, the flush catheter is loaded on the balloon guidewire and advanced into the graft. With the flush catheter positioned just proximal to the balloon, the flow control delivers saline through the flush catheter to gently wash the vessel and remove any debris generated during the intervention through the guide catheter into a collection bag. The TriActiv FX® Embolic Protection System has been designed to extract at a greater rate than it infuses to prevent aortic embolization. Once the physician is satisfied with the amount of debris removed from the vessel, the protection balloon is deflated and the device is removed.

Here's a breakdown of the acceptance criteria and the study details for the TriActiv FX® Embolic Protection System, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the TriActiv FX® Embolic Protection System were primarily established through a non-inferiority comparison to existing predicate devices (Medtronic Guardwire® or Boston Scientific Filterwire EX™). The key performance metrics are related to Major Adverse Cardiac Events (MACE) and other clinical outcomes.

⁴ Device success is defined as attainment of all of the following: the device was successfully delivered to the target location, the device operated as intended, the device was successfully retrieved.
*⁵ Final stenosis

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The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm – 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.

The Proxis System is also indicated to control the flow of fluids in the coronary and peripheral vasculature.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The Proxis System is a proximal embolic protection system used in conjunction with other interventional devices. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli release during an interventional procedure and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter compatible with 7F or larger guide catheters, Inflation device, Aspiration syringe, Lip Seal and Strainer basket. In addition, an optional accessory called the Proxis Infusion Catheter (packaged separately, K023548) may be used with Proxis System.

The Proxis catheter is loaded onto the guide wire and tracked down to the distal portion of the guide catheter and proximal to the lesion site. To minimize the occlusion time, the interventional devices are advanced through the Proxis catheter and positioned near the distal tip. When the sealing balloon is inflated, antegrade flow of the fluid in the target vessel is prevented. To minimize the release of embolic material, stagnation of flow is accomplished before any devices touch or cross- the lesion(s).

In the stagnant flow, the guide wire is advanced across the lesion site and the interventional device is tracked over the guide wire. After the treatment, fluid and particles from the procedure are evacuated using the aspiration syringe. If there is insufficient venous or collateral flow, the Proxis Infusion Catheter (optional accessory) may be used to deliver saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.

Here's a breakdown of the acceptance criteria and study information for the Proxis System, based on the provided 510(k) summary:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets but are implicitly derived from the non-inferiority comparisons to predicate devices in terms of major adverse cardiac events (MACE). The reported device performance is presented as the MACE rates for the Proxis System compared to the control arm (using market-cleared distal protection devices). The goal was to demonstrate non-inferiority of the Proxis System.

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The Proxis System is indicated for use as a proximal embolic protection system to prevent distal release of and to aspirate embolic material (thrombus/debris) in saphenous vein coronary bypass graft(s) (3.0 mm – 5.0 mm) during percutaneous transluminal coronary angioplasty and/or stenting procedures.

The Proxis System is also indicated to control the flow of fluids and aid in the removal of fresh, soft emboli and thrombi in the coronary and peripheral vasculature.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The Proxis Embolic Protection System is used in conjunction with other percutaneous transluminal coronary angioplasty devices (PTCA). It is compatible with 8F guide catheters. The Proxis System protects the patient from distal embolization by preventing antegrade flow of emboli released during a PTCA and then removing it from the vessel. The Proxis System consists of an Evacuation Sheath Catheter, Accessory Pack (contains an inflation system, evacuation syringe and double y-adaptor) and an optional additional accessory called the Proxis Infusion Catheter (packaged separately).

The Evacuation Sheath Catheter is loaded into the hemostasis valve and tracked down to the distal portion of the guide catheter. The Evacuation Sheath lines the inner lumen of the distal end of the guide catheter. When the sealing balloons are inflated, the proximal balloon seals against the guide catheter wall and the distal balloon seals against the blood vessel wall and the antegrade flow of the fluid in the target vessel is stopped. The stagnation of flow is accomplished before any devices touch or cross the lesion(s). This minimizes the distal release of embolic material.

Interventional devices are passed through the evacuation sheath to the treatment site and the procedure is performed in stagnant fluid. After the procedure, fluid and particles from the procedure are evacuated using the Evacuation Syringe. The Proxis Infusion Catheter may be used to augment the retrograde flow during the evacuation by infusing saline distal to the treatment site while simultaneously applying vacuum to evacuate fluid and particles from the treatment site.

This document describes the Proxis System, an embolic protection device, and the study supporting its expanded indications. Here's an analysis of the acceptance criteria and the study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes the "Proximal Trial" which assessed the safety and effectiveness of the Proxis System for embolic protection. The primary acceptance criterion appears to be non-inferiority in the 30-day Major Adverse Cardiac Event (MACE) rate compared to existing distal protection devices.

Interpretation: The reported performance of the Proxis System (9.2% MACE in the test arm) and the control arm (10.0% MACE) demonstrates a difference of -0.8% (Proxis

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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 SpideRX™ Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

The provided text is a 510(k) summary for the SpideRX™ Embolic Protection Device. It describes the device, its intended use, and the FDA's substantial equivalence determination. However, the document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any details related to device performance metrics typically found in clinical trials or validation studies.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (SpideRX Embolic Protection Device K053195) based on the device description and intended use, particularly the modification to reflect compatibility with drug-eluting stents.

Therefore, I cannot provide the requested table and study details as they are not present in the input text.

To directly answer your numbered points based on the provided text's limitations:

1. A table of acceptance criteria and the reported device performance: Not provided in the text.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not provided in the text.
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 provided in the text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the text.
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 relevant to this device, as it is a physical medical device (embolic protection system), not an AI-assisted diagnostic tool. No such study information is provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is not an algorithm or AI device. No such study information is provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not provided in the text. The 510(k) process for this type of device typically relies on bench testing, animal studies, and clinical data showing safety and effectiveness comparable to a predicate, but specifics are not in this summary.
8. The sample size for the training set: Not applicable/not provided. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable/not provided. This is a physical device, not a machine learning model.

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The TriActiv FX® Embolic Protection System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous vein coronary bypass grafts ranging from 3.0mm to 5.0m in diameter. The TriActiv FX® Embolic Protection System is intended to protect the distal coronary vasculature by trapping and extracting thrombotic and atheromatous debris liberated during PCI.

The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral, carotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The TriActiv FX® Embolic Protection System is a temporary balloon occlusion embolic protection device used during percutaneous coronary intervention of diseased saphenous vein grafts ranging from 3.0mm to 5.0mm in diameter. The device is comprised of four principal components: ShieldWire™ Balloon Guidewire ("balloon guidewire), ShieldWire™ Inflator ("inflator"), FX™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also four subcomponents or accessories included in the TriActiv FX® Embolic Protection System: the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, TriActiv® Flow Control Power Supply and TriActiv® Tuohy. All TriActiv FX® Embolic Protection System components are supplied sterile and for single use only with exception of the TriActiv® Flow Control Power Supply which is non-sterile and reusable.

The provided text describes the TriActiv FX® Embolic Protection System and its clinical evaluation, but it does not include a table of acceptance criteria or explicitly state acceptance criteria for device performance. It focuses on demonstrating non-inferiority to a predicate device based on clinical outcomes.

However, based on the clinical study results presented, we can infer what the implicit performance goals or "acceptance criteria" likely were, particularly in relation to the predicate device.

Here's an attempt to structure the information based on your request, inferring where explicit details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not presented in a table in the submission, the table below infers the performance goals based on the non-inferiority study results compared to the predicate. The "Acceptance Criteria" here are derived from the need to demonstrate non-inferiority to the Active Control Arm of the PRIDE Trial (using Guardwire® Plus System or FilterWire® EX System).

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The SpideRX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

The provided 510(k) summary describes the SpideRX™ Embolic Protection Device and its evaluation for substantial equivalence to predicate devices. It states that the device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) and also acts as a guidewire during percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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