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The EmboTrap® II 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.

Device Description

The EmboTrap® II 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® II 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. It is indicated for patients who are ineligible for intravenous tissue plasogen activator (IV t-PA) or who fail IV t-PA therapy.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:

Acceptance Criteria and Device Performance

Criteria Category	Acceptance Criteria	Reported Device Performance and Conclusion
Biocompatibility	All biocompatibility tests (MTT Cytotoxicity, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous, ISO Systemic Toxicity, USP Rabbit Pyrogen, ASTM Hemolysis, Complement Activation Assay) must meet pre-assigned acceptance criteria.	All biocompatibility tests completed met the pre-assigned acceptance criteria. The device was found to be non-cytotoxic, not a sensitizer, not an irritant, non-toxic, non-pyrogenic, non-hemolytic, and had acceptable levels of C3a and SC5b-9.
Sterilization	Device must be EO-sterilized to achieve a minimum SAL of 10-6.	The sterilization process was successfully validated and process monitoring controls assure a minimum SAL of 10-6.
Shelf Life	Shelf life studies must establish that the product and packaging remain functional and sterile for a period of 3 years.	Shelf life studies established that the product and packaging remain functional and sterile for a 3-year shelf life.
In Vitro (Bench) Testing	Device must fulfill all pre-determined product performance specification requirements for: Dimensional Testing (Radial Force, Outer Cage Recovery, Device Durability/Integrity, Joint Strength), Flexibility & Kink Resistance Testing (Torque Durability, Corrosion Resistance, Radiopacity, Tip Flexibility, Re-sheathing Force), Simulated Use/Performance Testing (Coating Integrity, Particulate Evaluation). Performance must be comparable to predicate devices.	The device fulfilled all pre-determined product performance specifications. Side-by-side bench testing showed the EmboTrap® II to be comparable or superior to its predicate devices in terms of performance and functionality for all tested characteristics (System Dimensions, Tip Flexibility, Re-sheathing force, Delivery and re-sheathing force during simulated use, Durability Testing, System Kink Resistance, Kink Resistance - Deployed Shaped Section, Distal Coil Tensile Testing, System Tensile Testing, Torque Testing in a Microcatheter, Torque Strength Testing, Radial Force Testing, Radiopacity, Clot retrieval and performance, and Physician usability testing).
In Vivo (Animal) Studies	Usability, effectiveness, and safety must be assessed in a swine model compared to predicate devices. Local and end organ tissue response must be comparable to predicate devices.	Acute performance on Day 0 showed equivalent usability and performance to the predicate device. Histological evaluation after 3 and 28 days demonstrated comparable local and end organ tissue response between the EmboTrap® II and predicate devices.
Clinical Efficacy (Primary Endpoint)	Revascularization rate (mTICI 2b or greater in the target vessel following 3 or less passes of the EmboTrap® device without rescue therapy) must be statistically significantly greater than a performance goal (NL) of 0.56 (56%). Null Hypothesis (H0: PEmboTrap ≤ 0.56) should be rejected in favor of the Alternative Hypothesis (H1: PEmboTrap > 0.56) at a one-sided Exact test for a binomial proportion at the 5% significance level.	The successful revascularization rate was 72% (137/191) with a 95% confidence interval of [65%, 78%]. The p-value was <0.0001, demonstrating that the revascularization rate was statistically significantly greater than the performance goal of 56%.
Clinical Safety (Primary Endpoint)	The occurrence of Symptomatic Intracerebral Hemorrhage (sICH) within 24 hours post-procedure, together with any other Serious Adverse Device Effects (SADE), excluding those already counted in sICH, must meet acceptable safety standards.	The occurrence of sICH within 24h and/or SADE was 5% (9/191) with an unadjusted 95% Confidence Interval of [2%, 9%].

Study Details for Clinical Performance (ARISE II Study)

1. Sample size used for the test set and the data provenance:

Test Set Sample Size: 191 patients (FDA Intention-to-Treat (ITT) Cohort).
Data Provenance: The study was a multi-center clinical trial. Explicit countries are not mentioned for the entire cohort, but results are broken down by "US cohort (N=94)" and "EU cohort (N=97)", indicating the data came from both the United States and European Union countries. The study was prospective in nature, as it was a clinical trial assessing the device's efficacy and safety before marketing approval.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The text states: "Angiographic data were obtained at baseline (prior to patient treatment), and again at the conclusion of each revascularization attempt, and after treatment." and "Successful achievement of the endpoint is defined as achieving an mTICI score of 2b or greater in the target vessel following 3 or less passes of the EmboTrap® device without the use of rescue therapy at any point during the procedure." The evaluation of revascularization (mTICI scores) was done by a Core Laboratory adjudicated data. While the exact number and qualifications of the experts in the Core Laboratory are not specified, a core lab typically consists of highly qualified, independent experts (e.g., neuro-interventional radiologists) blinded to treatment arms, who provide standardized, unbiased assessments of imaging.
"The Primary Safety Endpoint was adjudicated by the Clinical Events Committee (CEC)." Again, the exact number and specific qualifications are not provided, but a CEC typically comprises independent medical experts relevant to the study's focus (e.g., neurologists, intensivists).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The text explicitly mentions "Core Laboratory adjudicated data" for the primary efficacy endpoint (mTICI scores) and "Clinical Events Committee (CEC)" for the primary safety endpoint. This implies a formal adjudication process was used. However, the exact "X+Y" method (e.g., two readers, one tie-breaker) is not specified in the provided document.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, this was not an MRMC comparative effectiveness study involving AI-assistance. This was a clinical trial comparing the performance of a medical device (EmboTrap® II Revascularization Device) against a pre-specified performance goal derived from other clinical trials (SWIFT and TREVO 2) of similar, predicate devices. The study did not involve AI or assess human readers' improvement with or without AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this was not a standalone algorithm study. The study evaluated the clinical performance of a physical medical device used by human operators (physicians trained in neuro-interventional catheterization). There is no mention of an algorithm being tested in a standalone capacity.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For Efficacy: The ground truth for the primary efficacy endpoint (successful revascularization) was based on expert adjudication of angiographic data by a Core Laboratory, using modified Thrombolysis in Cerebrovascular Infarction (mTICI) scores.
For Safety: The ground truth for the primary safety endpoint (sICH and SADE) was established by expert adjudication from a Clinical Events Committee (CEC).
For Secondary Outcomes: Good clinical outcome (mRS score), mortality, and neurological deterioration were based on patient outcomes data (mRS, NIHSS scores) collected by healthcare professionals during follow-up.

7. The sample size for the training set:

This was a clinical trial and does not involve a "training set" in the context of an AI/algorithm study. The study evaluates the device's performance in a patient cohort (test set) based on pre-defined endpoints.

8. How the ground truth for the training set was established:

As stated above, this study does not involve an AI "training set." The clinical trial design assessed real-world patient outcomes with the device.

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