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The SpideRX Embolic Protection Device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris). The device also acts as the guidewire while performing percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm. The safety and effectiveness of this device as an embolic protection system has not been established in the cerebral or peripheral vasculature.

The SpideRX™ Embolic Protection Device is a percutaneously delivered distal embolic protection system that can be delivered over any 0.014" or 0.018" guidewire. The SpideRX Embolic Protection Device contains a Capture Wire composed of a nitinol mesh filter mounted on a convertible 190/320 cm PTFEcoated 0.014" stainless steel wire, and a dual-ended SpideRX Catheter for delivery and recovery.

The provided 510(k) summary describes the SpideRX™ Embolic Protection Device and its evaluation for substantial equivalence to predicate devices. It states that the device is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) and also acts as a guidewire during percutaneous transluminal coronary angioplasty or stenting procedures in coronary saphenous vein bypass grafts with reference vessel diameters of 3.0 to 6.0 mm.

Here's a breakdown of the acceptance criteria and study details based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are implicitly defined by the non-inferiority hypothesis, where the SpideRX device is considered non-inferior if the MACE rate difference from the control group is statistically significantly less than 5.5%.

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

• Sample Size (Randomized Portion):
  • SpideRX/Treatment Arm: 383 patients
  • Control Arm: 364 patients (FilterWire EX™ Embolic Protection System, FilterWire EZ™ Embolic Protection System, or GuardWire® Plus Temporary Occlusion and Aspiration System)
  • Total Randomized: 747 patients
• Data Provenance: The study was a "prospective, randomized, multi-center trial." The specific country of origin is not mentioned, but "multi-center" implies multiple locations, likely within the US, given the FDA submission.

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

The document does not mention the use of experts to establish ground truth for the test set in the context of diagnostic performance or image interpretation. The primary endpoint, 30-day MACE (Major Adverse Cardiac Events), including death, myocardial infarctions (MI), target vessel revascularizations, and emergent CABG (Coronary Artery Bypass Graft) procedures, are clinical outcomes rather than expert-interpreted data points. Myocardial infarctions are determined through lab tests (CK-MB results).

4. Adjudication Method for the Test Set

The document does not explicitly state an adjudication method for the events contributing to the 30-day MACE. However, the nature of clinical endpoints like death, MI (based on biomarkers), and revascularization often involves standardized definitions and potentially an independent clinical events committee for adjudication in a multi-center trial, though this is not explicitly detailed here. The discussion on missing CK-MB data and its statistical imputation suggests a rigorous approach to handling data, but not an "adjudication method" in the sense of reconciling expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This study is evaluating the clinical efficacy and safety of an embolic protection device, not a diagnostic AI system or an assistance tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

No, a standalone algorithm performance study was not done, as this evaluates a medical device (embolic protection device), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for evaluating the device's performance was clinical outcomes data, specifically the 30-day Major Adverse Cardiac Events (MACE), which includes:

• Death
• Myocardial Infarction (defined by CK-MB levels where possible)
• Target Vessel Revascularizations
• Emergent CABG procedures

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of an AI or algorithm development. The entire study cohort (963 total enrolled patients, 747 in the randomized portion) constitutes the clinical trial data used to evaluate the device. If an internal analysis or model was created to impute missing CK-MB data, it would have been trained on data from within the SPIDER trial that had complete CK-MB values, but this is not a "training set" for the device itself.

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

As no training set for an AI/algorithm was identified, this question is not applicable. The clinical outcomes that served as the "ground truth" for the device's evaluation (MACE) were established using standard clinical definitions and measurements (e.g., CK-MB for MI, clinical events for death, revascularization).

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