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As part of the Socrates Aspiration System, the Socrates 38 Aspiration Catheter with a compatible suction pump is indicated for use in the revascularization of patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral -M1 and M2 segments, basilar, and vertebral arteries) 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.

As part of the Socrates Aspiration System, the Socrates Aspiration Tubing is indicated to connect the Socrates 38 Aspiration Catheter to a compatible suction pump.

The Scientia Vascular Socrates Aspiration System is composed of two components: the Socrates 38 Aspiration Catheter, designed to aid in accessing vasculature, and the Socrates Aspiration Tubing, designed to connect the aspiration catheter to a compatible suction pump and control flow between them. When used with a compatible vacuum pump, these components facilitate the aspiration and removal of thrombus from the neurovasculature. Both components are supplied sterile for single use only.

The Socrates 38 Aspiration Catheter is a single lumen, variable stiffness catheter designed to be advanced over a steerable guidewire. The catheter shaft design includes nitinol, polymers of varying durometer, and an internal lubricious liner. To reduce friction during manipulation, a hydrophilic coating is applied to the distal exterior section of the catheter shaft. A single radiopaque tip marker provides visualization under fluoroscopy. The proximal end of the catheter includes a clear hub with Luer lock and a stainless-steel strain relief. The catheter is supplied sterile, for single use only and is packaged with a rotating hemostasis valve (RHV).

The Socrates Aspiration Tubing is designed to connect the Socrates 38 Aspiration Catheter to a compatible vacuum pump and control flow between them. The aspiration tubing consists of tubing attached to a suction connector on one end and a male Luer lock on the other with an intermediate on/off fluid flow control device and is supplied sterile and for single use only.

The provided FDA 510(k) summary for the Socrates Aspiration System does not contain information related to an AI/ML-enabled device or its performance criteria specific to AI/ML applications. The document describes a medical device for revascularization in acute ischemic stroke and its non-clinical performance data (biocompatibility, functional testing, and an animal study) to support substantial equivalence to a predicate device.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and a study that proves an AI-enabled device meets those criteria based on the provided text. The document clearly states:

• "The non-clinical performance data presented were determined to be sufficient to support the substantial equivalence of the Socrates Aspiration System. Therefore, no clinical study was conducted."
• There is no mention of an AI/ML component, a test set, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

If you have a document pertaining to an AI/ML medical device, please provide that.

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