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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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