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1. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion, and smaller core infarcts who have first received intravenous tissue plasminogen activator (IV t-PA). Endovascular therapy with the device should start within 6 hours of symptom onset.
2. The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
3. The Trevo Retriever is indicated for use to restore blood flow in the neurovasculature by removing thrombus for the treatment of acute ischemic stroke to reduce disability in patients with a persistent, proximal anterior circulation, large vessel occlusion of the internal carotid artery (ICA) or middle cerebral artery (MCA)-M1 segments with smaller core infarcts (0-50cc for age <80 years, 0-20cc for age ≥80 years). Endovascular therapy with the device should start within 6-24 hours of time last seen well in patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy.

The Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. Platinum markers at the distal end allow fluoroscopic visualization. In addition, the shaped section is also radiopaque. Retriever dimensions are indicated on product label. The Retriever delivery wire has a hydrophilic coating on the distal 101cm length to reduce friction during use. The Retriever has a shaft marker to indicate proximity of Retriever tip relative to Microcatheter tip. A Torque Device is provided with the Retriever to facilitate manipulation and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.

Here's a breakdown of the acceptance criteria and study information for the Trevo NXT ProVue Retriever, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The document primarily focuses on establishing substantial equivalence to a predicate device, specifically regarding a change in labeling for compatibility with smaller aspiration catheters. It doesn't explicitly state quantitative acceptance criteria for primary clinical endpoints of the device itself in the context of a de novo submission. Instead, it demonstrates through comparative data that the modified use case (with smaller catheters) maintains equivalent performance to the established use case.

Study Information

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set A (Simulated Use & Particulate Characterization): Sample sizes are not explicitly stated, but these were bench tests performed by Stryker Neurovascular.
   • Test Set B (Animal Study): Sample size for the animal study is not specified.
   • Test Set C (Real-World Data - RWD):
     • An administrative claims database (details regarding country/scope not specified).
     • Post-market registries: "The Trevo Retriever Registry" and "The ASSIST Registry" (details regarding country/scope not specified).
     • Retrospective data, as it's an "analysis of Real-World Data (RWD) from an administrative claims database, post-market registries...as well as a review of relevant literature."

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

   • The document does not specify the number or qualifications of experts for establishing ground truth for any of the clinical/RWD test sets. The RWD analysis likely used existing clinical outcomes as "ground truth." For bench and animal studies, "ground truth" would be determined by the study design and measurements.

3. Adjudication Method for the Test Set:

   • The document does not describe any adjudication method for the RWD or registry data.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study involving human readers or AI assistance in that direct context was described. The RWD analysis was focused on the device's performance with different aspiration catheter sizes, not on human-AI interaction.

5. Standalone (Algorithm Only) Performance:

   • Not applicable. The device is a physical neurovascular mechanical thrombectomy device, not an algorithm. The "performance data" refers to the device's efficacy and safety in its intended use.

6. Type of Ground Truth Used:

   • Bench Testing: Internal performance criteria and measurements.
   • Animal Study: Evaluation of vascular trauma, recanalization, and distal emboli based on experimental observations.
   • Real-World Data (RWD):
     • Patient outcomes data from an administrative claims database.
     • Revascularization rates (eTICI>2c) and 90-day Modified Rankin Scale (MRS) from post-market registries and relevant literature. This would be considered outcomes data.

7. Sample Size for the Training Set:

   • Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The document refers to testing data to support a change in labeling for compatibility.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable, as there is no "training set" for this physical device.

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