(186 days)
- 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.
- 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.
- 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 (0-50cc for age
The Trevo 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 delivery wire has a hydrophilic coating on the distal 101cm length 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 and retrieval. The Retriever comes preloaded in an insertion tool to introduce the Retriever into a Microcatheter.
Here's a breakdown of the acceptance criteria and study information for the Trevo NXT ProVue Retriever, based on the provided text:
Acceptance Criteria and Reported Device Performance
Note: The document primarily focuses on establishing substantial equivalence to a predicate device, specifically regarding a change in labeling for compatibility with smaller aspiration catheters. It doesn't explicitly state quantitative acceptance criteria for primary clinical endpoints of the device itself in the context of a de novo submission. Instead, it demonstrates through comparative data that the modified use case (with smaller catheters) maintains equivalent performance to the established use case.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Successful Clot Retrieval and Recanalization (Simulated Use) | Simulated Use testing met acceptance criteria. |
| Acceptable Particulate Generation | All test samples met the applicable user needs and acceptance criteria for particulate characterization when used with AXS Vecta 46 Intermediate Catheter. |
| Equivalence in Functional Outcome (Modified vs. Predicate Use) | Regression analysis of RWD indicated that using Trevo with 0.046in (1.17mm) ID aspiration catheters is equivalent to using Trevo with larger aspiration catheters with similar odds of good functional outcome (Odds Ratio: 0.72; 95% CI: 0.44-1.17). |
| Equivalence in Safety Endpoints (Modified vs. Predicate Use) | Regression analysis of RWD indicated similar odds for multiple safety endpoints when using Trevo with 0.046in (1.17mm) ID aspiration catheters compared to larger ones. |
| Equivalence in Revascularization Rates (Modified vs. Predicate) | Registry data confirmed equivalence of revascularization rates for eTICI>2c, with a 90% CI for the difference in means of severity-adjusted posterior probabilities from 0.003 to 0.009 (0.30% to 0.90%). This was within the equivalence margin of ±5%. |
| Equivalence in 90-day Modified Rankin Scale (MRS) (Modified vs. Predicate) | Registry data confirmed equivalence for 90-day MRS, with a 90% CI for the difference from -0.050 to 0.042 (-5.0% to 4.2%). This was within the equivalence margin of ±5%. |
Study Information
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set A (Simulated Use & Particulate Characterization): Sample sizes are not explicitly stated, but these were bench tests performed by Stryker Neurovascular.
- Test Set B (Animal Study): Sample size for the animal study is not specified.
- Test Set C (Real-World Data - RWD):
- An administrative claims database (details regarding country/scope not specified).
- Post-market registries: "The Trevo Retriever Registry" and "The ASSIST Registry" (details regarding country/scope not specified).
- Retrospective data, as it's an "analysis of Real-World Data (RWD) from an administrative claims database, post-market registries...as well as a review of relevant literature."
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- The document does not specify the number or qualifications of experts for establishing ground truth for any of the clinical/RWD test sets. The RWD analysis likely used existing clinical outcomes as "ground truth." For bench and animal studies, "ground truth" would be determined by the study design and measurements.
-
Adjudication Method for the Test Set:
- The document does not describe any adjudication method for the RWD or registry data.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers or AI assistance in that direct context was described. The RWD analysis was focused on the device's performance with different aspiration catheter sizes, not on human-AI interaction.
-
Standalone (Algorithm Only) Performance:
- Not applicable. The device is a physical neurovascular mechanical thrombectomy device, not an algorithm. The "performance data" refers to the device's efficacy and safety in its intended use.
-
Type of Ground Truth Used:
- Bench Testing: Internal performance criteria and measurements.
- Animal Study: Evaluation of vascular trauma, recanalization, and distal emboli based on experimental observations.
- Real-World Data (RWD):
- Patient outcomes data from an administrative claims database.
- Revascularization rates (eTICI>2c) and 90-day Modified Rankin Scale (MRS) from post-market registries and relevant literature. This would be considered outcomes data.
-
Sample Size for the Training Set:
- Not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The document refers to testing data to support a change in labeling for compatibility.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" for this physical device.
§ 882.5600 Neurovascular mechanical thrombectomy device for acute ischemic stroke treatment.
(a)
Identification. A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with an endovascular approach, mechanically removes thrombus from the body, and restores blood flow in the neurovasculature.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient contacting components of the device must be demonstrated to be biocompatible.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use, including:
(i) Mechanical testing to demonstrate the device can withstand anticipated tensile, torsional, and compressive forces.
(ii) Mechanical testing to evaluate the radial forces exerted by the device.
(iii) Non-clinical testing to verify the dimensions of the device.
(iv) Non-clinical testing must demonstrate the device can be delivered to the target location in the neurovasculature and retrieve simulated thrombus under simulated use conditions.
(v) Non-clinical testing must demonstrate the device is radiopaque and can be visualized.
(vi) Non-clinical testing must evaluate the coating integrity and particulates under simulated use conditions.
(vii) Animal testing must evaluate the safety of the device, including damage to the vessels or tissue under anticipated use conditions.
(3) Performance data must support the sterility and pyrogenicity of the patient contacting components of the device.
(4) Performance data must support the shelf-life of the device by demonstrating continued sterility, package integrity, and device functionality over the specified shelf-life.
(5) Clinical performance testing of the device must demonstrate the device performs as intended for use in the treatment of acute ischemic stroke and must capture any adverse events associated with the device and procedure.
(6) The labeling must include:
(i) Information on the specific patient population for which the device is intended for use in the treatment of acute ischemic stroke, including but not limited to, specifying time from symptom onset, vessels or location of the neurovasculature that can be accessed for treatment, and limitations on core infarct size.
(ii) Detailed instructions on proper device preparation and use for thrombus retrieval from the neurovasculature.
(iii) A summary of the clinical testing results, including a detailed summary of the device- and procedure-related complications and adverse events.
(iv) A shelf life.