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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

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.

The acceptance criteria for the Trevo NXT ProVue Retriever are not explicitly stated in numerical thresholds within the provided text. However, the document asserts that the device is substantially equivalent to its predicate device (K210502) and that the performance is "similar" to established safety and performance profiles. The primary change supported by this submission is a labeling modification concerning the minimum vessel diameter for certain models.

Here's an attempt to structure the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide specific quantitative acceptance criteria or numerical performance metrics for the Trevo NXT ProVue Retriever. Instead, it relies on demonstrating substantial equivalence to a predicate, particularly in the context of a labeling change for compatibility. The "performance" assessment is qualitative, focusing on "similar performance and safety profile".

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

• Test Set Description: A "retrospective analysis of device performance per vessel size" was conducted.
• Sample Size: Not explicitly stated. The analysis was performed "using The ASSIST Registry data." The number of cases or patients included in this retrospective subgroup analysis is not provided.
• Data Provenance: Retrospective. The country of origin of "The ASSIST Registry" data is not specified in the provided text.

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

• The document does not mention the use of experts to establish ground truth for "The ASSIST Registry data" specifically for this retrospective analysis. The data from "The ASSIST Registry" would presumably have its own established ground truth generated during data collection, but this is not detailed here. The submission focuses on analyzing existing data.

4. Adjudication Method for the Test Set

• Not applicable/Not mentioned. The study involved a retrospective analysis of registry data, not a new dataset requiring expert adjudication for ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study was a retrospective analysis of an existing registry.

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

• Not applicable. The device is a mechanical thrombectomy device, not an algorithm or AI. The "performance" refers to the clinical effectiveness of the physical device.

7. The Type of Ground Truth Used

• For the retrospective analysis of "The ASSIST Registry data," the ground truth would be the clinical outcomes data and procedural data recorded within that registry. For example, successful recanalization (restoring blood flow), reduction in disability, and safety events (as mentioned in "similar performance and safety profile").

8. The 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.

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

• Not applicable. (See #8)

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