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The TriActiv® System is indicated for use in conjunction with percutaneous coronary intervention (PCI), using a 7F guide catheter (without side holes), of diseased saphenous mice vention (1 U), assign from 3.0mm to 5.0mm in diameter. The TriActiv® vent coronal y of pass grates 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 r the salery and broot. Annus arotid, or peripheral vasculature; native coronary arteries; or for treatment of patients with acute myocardial infarction.

The TriActiv® 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 ShieldWire™ Temporary Occlusion Balloon Guidewire ("balloon components: guidewire), Balloon Inflation Syringe, FlushCath™ Catheter ("flush catheter"), and AutoStream™ Flow Control ("flow control"). There are also five subcomponents or accessories included in the TriActiv® System: the split tube introducer, guidewire plug and installer, AutoStream™ Flow Control Power Supply, TriActiv® Tuohy, and flush catheter attachment tool. All TriActiv® System components are supplied sterile and for single use only with exception of the AutoStream™ 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 graft (SVG) and positioned just past the target lesion.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text, with clarifications for missing information:

Device: TriActiv® System (Distal Occlusion Balloon Catheter)
Predicate Device: PercuSurge GuardWire® Temporary Occlusion and Aspiration System (K013913)

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the TriActiv® System, as stated in this 510(k) summary, is non-inferiority to existing embolic protection devices for preventing Major Adverse Cardiac Events (MACE) during saphenous vein graft PCI.

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

• Sample Size (Test Set):

  • PRIDE Study Cohort 2 (Primary Test Set): 631 patients total.
    • TriActiv® arm: 313 patients
    • Active Control arm: 318 patients
  • PRIDE Study Cohort 1 (Pilot/Exploratory): 62 patients total.
    • TriActiv® arm: 33 patients
    • Placebo arm (no embolic protection): 29 patients
  • Roll-In: 201 patients (likely for initial experience and device and protocol refinement, not a primary test set for effectiveness)

• Data Provenance: Prospective, multi-center clinical trial.

  • Countries: 68 sites in the United States and 10 sites in Europe.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the clinical endpoints (like MACE, MI, etc.). However, for a multi-center randomized controlled trial of this nature, it is standard practice to have:

• An independent Clinical Events Committee (CEC) to adjudicate clinical endpoints (like MACE components, MI diagnoses), often comprising cardiologists or other relevant specialists.
• An independent Data Safety Monitoring Board (DSMB).
• Core laboratories for imaging (e.g., QCA for stenosis measurements), staffed by qualified specialists (e.g., interventional cardiologists, radiologists trained in angiography).

Without specific mentions, inferring the exact number and detailed qualifications of these adjudicating experts is not possible from the provided text. The text does mention "Final stenosis < 50% by QCA", implying that Quantitative Coronary Angiography (QCA) experts were involved.

4. Adjudication Method for the Test Set

The document does not explicitly describe the adjudication method (e.g., 2+1, 3+1). However, the mention of "MACE to 30 days" and its components (Death, MI, TVR, Emergent CABG), as well as separate reporting of "Non Cardiac death", strongly implies that an independent Clinical Events Committee (CEC) was used, which is standard for clinical trials of this type. CECs typically use a blinded, consensus-based review process (often involving multiple readers and a tie-breaker if needed, which would be a form of n+1 adjudication).

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

This was a clinical trial comparing patient outcomes (MACE rates) between two groups: one treated with the TriActiv® device and another with other active embolic protection systems, and an earlier cohort with no embolic protection. MRMC studies are typically used to compare the performance of diagnostic devices or algorithms (e.g., AI with physician vs. physician alone) by having multiple human readers interpret the same cases. This study evaluated the clinical effectiveness of a therapeutic/protective device based on patient outcomes, not diagnostic accuracy or human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The TriActiv® System is a medical device (a catheter system), not an AI algorithm. Therefore, a "standalone algorithm performance" study is not relevant to this product.

7. Type of Ground Truth Used

The ground truth for the primary endpoint (30-day MACE rates) and other clinical outcomes was established through clinical event adjudication based on patient follow-up data (such as hospital records, clinical evaluations, and potentially imaging results like QCA). This is a form of outcomes data, likely judged by an independent Clinical Events Committee (as inferred in point 4).

For "Procedure Success" and "Lesion Success," the ground truth involved quantitative coronary angiography (QCA) results (final stenosis < 50%) combined with clinical outcomes (no in-hospital MACE for procedure success).

8. Sample Size for the Training Set

Not applicable. This device is a physical medical device (catheter system), not an AI algorithm or a diagnostic tool that relies on a "training set" of data in the computational sense. The "training" for such devices involves preclinical testing, animal studies, and initial human experience (e.g., the "Roll-In" cohort in the PRIDE study could be considered akin to a very early human experience phase, though not a formal "training set" for an algorithm).

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

Not applicable, as there is no "training set" in the context of an AI algorithm.

If "training set" is meant more broadly for the development of the device, then the design and refinement of the device benefited from:

• Non-clinical verification and validation: Extensive in vitro bench testing, biocompatibility testing, software validation, package integrity testing, shelf life testing.
• In vivo animal studies.
• Early human experience: The "Roll-In" cohort (201 patients) and potentially Cohort 1 (62 patients) from the PRIDE study contributed to understanding device performance and leading to design modifications (e.g., from Version 1 to Version 2 of the device). The document mentions changes were made to "improve the product overall," "address physician requests to improve ease of use," and "improve manufacturability outcomes" based on this experience.

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