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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.

Study Information

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

   • Test Set (Randomized Patients): 594 patients were included in the analysis (294 in the Test arm - Proxis Embolic Protection System + current practice, and 300 in the Control arm - current practice with market cleared distal protection devices).
   • Additional Patients: 117 roll-in patients and 5 educational patients were also enrolled.
   • Data Provenance: Prospective, multi-center clinical trial (Proximal Trial) conducted across 68 investigational sites in Canada, Europe, and the United States.

2. 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 of experts or their specific qualifications for establishing the ground truth for MACE events. However, in clinical trials for cardiac devices, MACE events are typically adjudicated by an independent clinical events committee (CEC) composed of cardiologists with extensive experience.

3. Adjudication method for the test set:

   • The specific adjudication method (e.g., 2+1, 3+1) for the MACE events is not detailed in the provided summary. As mentioned above, MACE events in clinical trials are usually adjudicated by an independent CEC.

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 involving human readers and AI assistance was not done. This study is evaluating the effectiveness and safety of a medical device (embolic protection system) in preventing adverse clinical events, not the performance of an AI algorithm in interpreting medical images.

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

   • No, this is a study of a medical device, not an AI algorithm. Therefore, a standalone algorithm performance study was not conducted.

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

   • The primary ground truth used for assessing device effectiveness and safety was clinical outcomes data, specifically Major Adverse Cardiac Events (MACE). MACE is an aggregate endpoint that typically includes events like death, myocardial infarction, and repeat revascularization, which are determined by clinical observation and diagnostic criteria.

7. The sample size for the training set:

   • There is no explicit training set in the context of this device study. This is a clinical trial evaluating the safety and effectiveness of a physical medical device, not an AI algorithm that requires a training set. The "training" for the device, if one could apply the term analogously, would be its design, manufacturing processes, and in vitro/animal testing.

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

   • Not applicable, as there was no AI algorithm or "training set" in the sense of machine learning. The device's "ground truth" during its development would have been established through engineering specifications, bench testing against functional requirements, biocompatibility testing, and animal studies to ensure its performance and safety characteristics.

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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 < Control). The upper confidence interval (CI) for this difference was 4% (for the ITT population) and 0.3% (for the as-treated population). Both of these are "well below" the absolute non-inferiority delta of 7.0% and the relative delta of 5.5%, indicating that the Proxis System was found to be non-inferior to the predicate devices.

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

• Sample Size: 600 randomized patients, with an additional 117 roll-in and 5 educational patients.
  • Included in Analysis: 594 randomized patients.
• Data Provenance: The study was conducted in 68 investigational sites across Canada, Europe, and the United States. It was a prospective clinical trial ("Proximal Trial").

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

The document does not specify the number of experts used to establish the ground truth for the MACE events, nor their specific qualifications. Typically, MACE events in clinical trials are adjudicated by an independent clinical events committee (CEC) composed of experts (e.g., cardiologists), but this detail is not provided in the summary.

4. Adjudication Method for the Test Set:

The document does not specify the adjudication method for MACE events (e.g., 2+1, 3+1, none). It mentions that "the 30 day MACE rate is 9.2% in the Test arm and 10.0% in the Control arm," implying that MACE events were tracked and presumably adjudicated, but the method is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 study is a clinical trial comparing two device-based interventions (Proxis vs. existing distal protection devices) in human patients, not an AI efficacy study involving human readers.

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

• No, a standalone algorithm performance study was not done. The Proxis System is a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

• The ground truth for the "Proximal Trial" was clinical outcomes data, specifically the occurrence of Major Adverse Cardiac Events (MACE) at 30 days. This involves documented clinical events such as death, myocardial infarction, and target vessel revascularization, diagnosed by medical professionals.

8. The Sample Size for the Training Set:

• Not applicable. The "Proximal Trial" is a clinical efficacy and safety trial designed to evaluate a physical medical device, not to train a machine learning algorithm. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As noted above, there is no training set for an AI/ML algorithm in this context. The study established the ground truth (MACE rates) from the observed clinical events in the randomized patient population.

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The Proxis System controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.

The Proxis System has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter, and an Evacuation syringe.

The Evacuation Sheath Catheter has two low-pressure compliant sealing balloons that are inflated simultaneously. The proximal balloon stays within the guide catheter while the distal balloon resides in the arterial vessel. Radiopaque markers at the two balloon sites facilitate visualization and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloons are inflated using the Inflation Svstem.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the sealing balloons are inflated to occlude the vessel. Infusing ~0.5cc of contrast dye through the guide catheter will produce a continuous "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, while the vessel is occluded, therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the guide catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device.

The Evacuation syringe is provided for the removal of the fluid and the emboli/thrombi during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal the emboli/thrombi.

This document describes a 510(k) premarket notification for the Velocimed Proxis System, a percutaneous catheter. The submission primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain a study demonstrating device performance against specific acceptance criteria for diagnostic or clinical effectiveness. Instead, it describes compliance with various performance requirements and standards for medical devices.

Here's an analysis of the provided text in relation to your request:

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

The document does not present specific acceptance criteria in a quantitative table format for clinical performance or diagnostic accuracy. Instead, it lists broader performance requirements and compliance with international standards for medical devices.

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

The document describes performance testing of the device, primarily focusing on physical and mechanical properties, and biological safety. It does not describe a clinical study with a "test set" in the context of diagnostic accuracy or clinical effectiveness on patients. Therefore, information on sample size, data provenance, and study design for such a "test set" (e.g., patient data) is not applicable or provided in this submission for this type of device. The testing described would typically involve laboratory-based testing of device units.

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)

This information is not applicable as the document does not describe a study involving expert-established ground truth on patient data for diagnostic or clinical performance. The "ground truth" for the performance tests described (dimensional, tensile, etc.) would be established by engineering specifications and objective measurements against those specifications.

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

This information is not applicable as there is no mention of a "test set" requiring expert adjudication for clinical or diagnostic outcomes.

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. The Proxis System is a medical device (a catheter) for controlling fluid flow and temporary occlusion, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

This information is not applicable. The Proxis System is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

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

Given the nature of the device and the performance data described, the "ground truth" would be based on:

• Engineering specifications and objective physical measurements for dimensional verification, balloon compliance, tensile strength, torque, flexibility, and trackability.
• Established biological testing protocols for ISO 10993 (biological evaluation).
• Standardized testing procedures for packaging integrity and sterilization validation.

8. The sample size for the training set

This information is not applicable. The Proxis System is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

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

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