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1. The Solitaire™ Platinum Revascularization Device 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 be started within 6 hours of symptom onset.
2. The Solitaire™ Platinum Revascularization Device is indicated to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for IV t-PA or who fail IV t-PA therapy are candidates for treatment.

The Solitaire™ Platinum Revascularization Device is designed to restore blood flow by removing thrombus in patients experiencing ischemic stroke due to large intracranial vessel occlusion. The Solitaire™ Platinum Revascularization Device is designed for use in the neurovasculature such as the internal carotid artery, M1 and M2 segments of the middle cerebral artery, basilar, and the vertebral arteries. The distal, nitinol portion of the device facilitates clot retrieval and features an "overlap-design." The Solitaire™ Platinum Revascularization Device is designed with Platinum/Iridium radiopaque markers on the proximal and distal ends. In addition, the Solitaire™ Platinum Revascularization Device features radiopaque markers along the circumference of the working length. The Solitaire™ Platinum Revascularization Device is supplied sterile and intended for single-use.

The purpose of this submission is to modify the labeling for the subject Solitaire™ Platinum Revascularization Device to increase the number of flow restoration recoveries per device, align the minimum recommended vessel diameter across all models, and to update the list of optional accessories to include a guide catheter (minimum 5F).

The request asks to describe the acceptance criteria and study proving device meets these criteria, but the provided text is a 510(k) summary for a medical device which does not contain information about acceptance criteria or specific study results in the manner requested (e.g., performance metrics, sample sizes, expert ground truth establishment for an AI/imaging device).

The document is a premarket notification for a predicate device, specifically the Solitaire™ Platinum Revascularization Device, which is a mechanical thrombectomy device for acute ischemic stroke treatment. The submission aims to modify its labeling, not to introduce a new AI/imaging device or to provide detailed clinical study results with acceptance criteria tables.

Therefore, I cannot fulfill the request based on the provided text, as this information is not present within the document. The document primarily discusses device comparison to predicates, manufacturing details, and general compliance with regulations.

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