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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)-MI segments with smaller core infarcts (0-50 cc for age < 80 years, 0-20 cc 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.

This document describes the Stryker Neurovascular Trevo XP ProVue Retriever and Trevo NXT ProVue Retriever, neurovascular mechanical thrombectomy devices reviewed under K203219. The submission confirms substantial equivalence to previous devices (K190779 and K200117) made by the same manufacturer. The core argument for substantial equivalence relies on the fact that the indications for use, materials, manufacturing processes, design, technology, biocompatibility, packaging, and sterilization methods remain the same, with the only change being a modification to the core wire dimension.

Here's an analysis of the provided information concerning acceptance criteria and the study proving adherence:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance values for each test. Instead, it provides a summary of various bench tests and their "Conclusions," stating that "Device integrity met acceptance criteria," "Deliverability force met acceptance criteria," etc. The specific quantitative acceptance values are not detailed.

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

The document states that for some bench tests (e.g., Insertion Tool Use, Resheathability, Retractability, Kink Resistance, Reloadability, Retrievability), the device was subjected to "3 runs of simulated use." For other tests like torque/tensile durability, curl resistance, and various tensile strength tests, specific run counts or minimum forces are mentioned, but not the total number of devices or components tested to achieve those results.

The data provenance is bench testing only. No patient data (clinical or retrospective/prospective) was used for evaluation of the modified device in this submission, as per their statement: "No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology."

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

Not applicable. The tests are bench tests comparing the physical properties of the modified device to the predicate. There is no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes for this submission.

4. Adjudication Method for the Test Set

Not applicable. This was predominantly bench testing of device components, not a clinical study requiring adjudication of expert interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a medical device (mechanical thrombectomy retriever), not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.

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

Not applicable. This is a mechanical medical device, not an algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" or reference standard would be the established engineering specifications and performance characteristics of the predicate device, or relevant industry standards (e.g., ISO standards mentioned). The assessment is against these predefined engineering and safety specifications, not against clinical outcomes or pathology reports.

8. The Sample Size for the Training Set

Not applicable. This is a mechanical device, not a machine learning algorithm requiring a "training set."

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

Not applicable. As above, this is a mechanical device, not an algorithm based on a training set.

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