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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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