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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 System: the Split Tube Introducer, Shieldwire™ Guidewire Plug and Installer, 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 provided text describes the TriActiv FX® Embolic Protection System and its clinical evaluation, but it does not include a table of acceptance criteria or explicitly state acceptance criteria for device performance. It focuses on demonstrating non-inferiority to a predicate device based on clinical outcomes.

However, based on the clinical study results presented, we can infer what the implicit performance goals or "acceptance criteria" likely were, particularly in relation to the predicate device.

Here's an attempt to structure the information based on your request, inferring where explicit details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit acceptance criteria are not presented in a table in the submission, the table below infers the performance goals based on the non-inferiority study results compared to the predicate. The "Acceptance Criteria" here are derived from the need to demonstrate non-inferiority to the Active Control Arm of the PRIDE Trial (using Guardwire® Plus System or FilterWire® EX System).

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets (or in this case, is non-inferior to) these criteria is the ASPIRE (Angioplasty in SVGs with Post Intervention Removal of Embolic Debris) Study.

2. Sample Size and Data Provenance for the Test Set

• Sample Size (Test Set): 93 patients (Enrollment Phase of the ASPIRE Study).
• Data Provenance: Prospective, multi-center, non-randomized study conducted at 17 U.S. and 3 German investigational sites. Historical control data (318 patients) was used from the PRIDE Study (Active Control group: Medtronic Guardwire® or Boston Scientific Filterwire EX™).

3. Number of Experts and Qualifications for Ground Truth (Test Set)

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). Clinical trials like ASPIRE typically involve:

• Investigating physicians: Board-certified interventional cardiologists are implicitly the "experts" performing the procedures and making clinical assessments that contribute to endpoint determination (e.g., MACE, MI).
• Clinical Events Committee (CEC): Often, clinical events in such studies are adjudicated by an independent CEC composed of qualified physicians (e.g., cardiologists) from diverse backgrounds to ensure unbiased endpoint classification. The document does not explicitly mention a CEC, but it's a standard practice for studies of this nature.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the test set. However, the reference to "adjusted based on subclassifications from a propensity score analysis" and comparison to a historical control group suggests a statistical approach to account for potential confounding factors rather than a specific expert adjudication model for individual case diagnosis. Clinical event definitions (e.g., for MACE, MI) would have been pre-specified in the study protocol, and their occurrence likely determined by the clinical investigators and potentially confirmed by an independent committee.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This study focuses on clinical outcomes in patients, comparing the device's performance to a historical control group, rather than evaluating human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone (algorithm only) performance study was not done. The TriActiv FX® Embolic Protection System is a medical device (physical system for embolic protection), not an AI algorithm. The study evaluated the clinical performance of the device in vivo during PCI procedures.

7. Type of Ground Truth Used

The "ground truth" for the clinical study was based on clinical outcomes data from patients, including:

• Major Adverse Cardiac Events (MACE) - a composite endpoint typically including death, MI, and target vessel revascularization (TVR).
• Individual clinical events such as MI (Q wave and non-Q wave), death (cardiac and non-cardiac), stroke, hemorrhagic/vascular complications.
• Device success, procedure success, and lesion success, which are defined by criteria related to the technical performance of the device and immediate post-procedure findings (e.g., final stenosis by QCA, TIMI flow).

These outcomes are collected and reported by clinical investigators in accordance with the study protocol.

8. Sample Size for the Training Set

The document does not mention a "training set" in the context of an algorithm or AI. Since this is a physical medical device, there is no algorithm training set. The "training" referred to in the document is for the human investigators learning to use the device: "Investigators in the study were allowed up to 3 'roll-in' patients, for training purposes, which accounted for 20 of the 113 patients." These "roll-in" patients were excluded from the primary efficacy analysis (N=93).

9. How Ground Truth for the Training Set Was Established

As there is no algorithm training set, this question is not applicable. The "roll-in" patients were used for physician training, and their outcomes were not part of the primary efficacy analysis.

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