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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 < 50% by QCA for all lesions and no in-hospital MACE.
⁶ Final stenosis < 50% by QCA.

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

• Sample Size (Test Set):
  • TriActiv FX® (ASPIRE Study): 93 patients in the Enrollment Phase (113 total patients enrolled, 20 were "roll-in" patients for training).
  • Control (PRIDE Study Active Control): 318 patients.
• Data Provenance:
  • Country of Origin: The ASPIRE Study was conducted at 17 U.S. and 3 German investigational sites. The PRIDE Study data is referred to as "historical control data" and is implied to be from a similar multi-center, potentially international, context given the device manufacturers.
  • Retrospective or Prospective:
    • ASPIRE Study: Prospective, multi-center, non-randomized.
    • PRIDE Study Active Control: Retrospective (used as historical control data). The PRIDE study itself was likely prospective, but the data was utilized retrospectively for comparison in this 510(k).

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The outcomes (e.g., MACE, MI) are clinical endpoints based on patient diagnosis and objective measurements, likely adjudicated by physicians involved in the studies, but specific details on an adjudication committee or expert panel for ground truth are not provided in this summary.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the test set (e.g., 2+1, 3+1). Clinical events like MACE and MI are typically adjudicated by an independent clinical events committee in large trials, but this specific detail is not present in the summary.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an embolic protection system, a physical medical device, not an AI or imaging diagnostic tool that would typically involve "human readers" or "AI assistance." The study evaluates the device's clinical performance in preventing adverse events during a procedure.

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

Not Applicable. This is a physical medical device, not a software algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

The ground truth for evaluating the device's performance was based on clinical outcomes data. Specifically, it included:

• Major Adverse Cardiac Events (MACE)
• Death (Cardiac, Non-Cardiac)
• Myocardial Infarction (MI) (Q wave, Non-Q wave)
• Target Vessel Revascularization (TVR)
• Stroke
• Hemorrhagic/vascular complications
• Transfusion
• Device Success (defined by successful delivery, operation, and retrieval)
• Procedure Success/Patient (defined by final stenosis < 50% by QCA and no in-hospital MACE)
• Lesion Success/Lesion (defined by final stenosis < 50% by QCA)
• Final TIMI Flow

These are direct clinical endpoints and objective measurements taken during and after the intervention.

8. The Sample Size for the Training Set

The document refers to "roll-in" patients for training purposes within the ASPIRE study:

• Training Set Size: 20 patients (out of 113 total enrolled in ASPIRE). These were for "training purposes" for the investigators, not for training a machine learning model.

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

For the 20 "roll-in" patients, the ground truth was established through standard clinical evaluation and reporting of outcomes, similar to the main study patients. However, their data was likely not included in the primary efficacy analysis for statistical rigor, as their purpose was for investigator training/familiarization with the device. This "training" refers to human operators learning to use the device, not a machine learning model.

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