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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 (0-50 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 family, including the Trevo ProVue and Trevo XP ProVue 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 has a hydrophilic coating 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. The torque device is used to lock the core wire to the microcatheter during the procedure. Locking of the torque device to the wire allows the microcatheter and Retriever to be retracted as a system during clot retrieval. An insertion tool is provided to introduce the Retriever into a Microcatheter. The Insertion Tool is a sheath in which the Retriever comes preloaded. Once half the retriever's length is inserted into the microcatheter, the insertion tool is removed. Retrievers have a modified proximal end that permits attachment of the Abbott Vascular DOC Guide Wire Extension (REF 22260). Joining Guide Wire Extension to Retriever facilitates removal or exchange of a catheter while maintaining Retriever position in anatomy. After exchange has been completed, the extension can be detached.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a bulleted or numbered list with specific thresholds. Instead, the study aims to demonstrate superior clinical outcomes for the treatment arm compared to the control arm across several endpoints. The success thresholds are defined within the study design.

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

• Test Set Sample Size: 206 subjects (107 in the Treatment Arm, 99 in the Control Arm).
• Data Provenance: The DAWN™ study (IDE G130223) was a "multi-center, ... conducted in multiple countries." The document doesn't specify the exact countries, but it indicates an international scope. The study was prospective, randomized, open, masked endpoint trial.

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

The document mentions "masked endpoint trial" and "CEC adjudication" (Clinical Events Committee). While it confirms the involvement of a committee for adjudication, it does not specify the exact number of experts or their specific qualifications (e.g., number of years of experience, subspecialty) for establishing the ground truth.

4. Adjudication Method for the Test Set:

The exact adjudication method (e.g., 2+1, 3+1) is not explicitly stated. However, it refers to "CEC adjudication," indicating that a Clinical Events Committee independently reviewed and determined certain outcomes (e.g., sICH, neurological deterioration, all-cause mortality, serious adverse events). This typically implies a consensus-based approach among committee members.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed as described in the document. The study was a randomized controlled trial comparing the Trevo thrombectomy device plus medical management to medical management alone. This is a direct patient outcome study, not a study of human readers' performance with or without AI assistance. The Trevo Retriever is a medical device for mechanical thrombectomy, not an AI diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This question is not applicable as the Trevo Retriever is a physical medical device (neurovascular mechanical thrombectomy device), not a standalone algorithm or AI. Its performance is directly measured in terms of patient outcomes and procedural metrics.

7. Type of Ground Truth Used:

The ground truth used in the DAWN study was based on patient outcomes data, specifically:

• Clinical Outcomes: Modified Rankin Scale (mRS) at 90 days (utility-weighted and dichotomized).
• Neurological Assessment: NIHSS scores (for early neurological response and deterioration).
• Imaging Data: Recanalization rates (CTA or MRA at 24 hours), core infarct volume (for inclusion criteria and statistical adjustment).
• Safety Endpoints: Stroke-related mortality, sICH (ECASS III definition), all-cause mortality, and adverse events (adjudicated by CEC).

8. Sample Size for the Training Set:

The document describes a clinical trial (DAWN study) to evaluate the device in general, not specifically an AI model with a separate training and test set. Therefore, there is no "training set" for an AI algorithm mentioned in the context of this device's premarket notification. The entire DAWN study cohort (206 subjects) served as the dataset for evaluating the device's effectiveness and safety.

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

As there is no "training set" for an AI algorithm, this question is not applicable. The clinical trial data was gathered through the rigorous protocol of the DAWN study, including masked endpoint assessment and CEC adjudication for relevant clinical and safety outcomes, which served as the "ground truth" for evaluating the device's performance in comparison to standard medical management.

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