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The EMBOTRAP™ III Revascularization Device 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.

The EMBOTRAP™ III Revascularization Device is composed of a retrievable, self-expanding, Nitinol shaped section at the distal end of a tapered Nitinol shaft. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. The EMBOTRAP™ III Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.

This is an analysis of a 510(k) submission for the EMBOTRAP™ III Revascularization Device. The provided document does not describe acceptance criteria and a study proving device performance in the context of an AI/ML medical device. Instead, it details the substantial equivalence of a physical medical device (a thrombus retriever) to predicate devices through various non-clinical tests.

Therefore, I cannot extract the information requested as it pertains to AI/ML device acceptance criteria and studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth establishment for training set).

The document focuses on:

1. Biocompatibility Testing: Demonstrating the device is non-cytotoxic, non-sensitizing, non-irritant, non-toxic, non-pyrogenic, non-hemolytic, has acceptable complement activation, and is thromboresistant.
2. Sterilization and Shelf Life: Validating the EO sterilization process and a 3-year shelf life.
3. In Vitro (Bench) Testing: Evaluating physical characteristics like dimensions, radial force, cage recovery, durability, tensile strength, marker push-out force, flexibility, kink resistance, coating integrity, torque durability, corrosion resistance, tip flexibility, re-sheathing force, deliverability force, radiopacity, clot retrieval performance, and physician usability.
4. In Vivo (Animal) Studies: Assessing usability, effectiveness, and safety in a swine model, comparing it to predicate devices.
5. Clinical Studies: Stating that no clinical study was performed because there was no change to the indications for use or fundamental scientific technology (this is typical for a 510(k) focused on substantial equivalence to existing devices).

Given the nature of the device (a thrombus retriever), the acceptance criteria and performance data are entirely focused on physical and biological characteristics, not AI/ML performance metrics.

In summary, the provided text does not contain any information relevant to the acceptance criteria or study design for an AI/ML medical device.

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