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510(k) Data Aggregation
(126 days)
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.
Like the predicate device, the Trevo Retriever consists of a flexible, tapered core wire with a shaped section at the distal end and is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. A radiopaque coil at the distal end allows fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever. The proximal end of the device is compatible with the Abbott guide wire extension to facilitate removal or exchange of a catheter while maintaining the Retriever position in the vessel.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The study aimed to demonstrate the non-inferiority of the Trevo Retriever compared to the predicate Merci Retriever.
Table 1: Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance (Non-Inferiority Margin) | Trevo Retriever Performance (vs. Merci) | Met? |
|---|---|---|---|
| Primary Efficacy Endpoint: Post-Device Revascularization Success (TICI ≥2a) | Non-inferiority margin of 10% | Trevo: 87.3% (69/79) Merci: 58.0% (47/81) Difference: 29.3% (95% CI: 15.0%, 42.4%) p-value < 0.0001 (non-inferiority & superiority) | Yes |
| Primary Safety Endpoint: Incidence of procedure-related serious adverse events through 24 hours post-procedure (Composite Events) | Not explicitly defined as a statistical hypothesis for non-inferiority. The goal was to show safety comparable to or better than the predicate. | Trevo: 13.9% (11/79) Merci: 23.5% (19/81) Difference: -9.5% (95% CI: -22.1%, 2.8%) p-value = 0.1567 (Fisher's exact test of difference). The rate was numerically lower for Trevo. | Yes |
Note: While a specific numerical acceptance criterion for the primary safety endpoint wasn't stated in terms of non-inferiority, the clinical trial demonstrated a numerically lower (and thus favorable) rate of adverse events for the Trevo device.
Study Details:
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- Total randomized patients: 178
- Patients meeting angiographic entry criteria and included in primary analysis: 160 (79 for Trevo, 81 for Merci)
- Data Provenance: The data was obtained from a multi-center, prospectively controlled IDE clinical trial (TREVO 2). The document does not explicitly state the country of origin, but "IDE clinical trial" implies it was conducted under FDA regulations, typically within the United States, although international sites are possible. The study design is prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document mentions that "Primary Efficacy was assessed by the independent Core Lab." While it specifies a "Core Lab," it doesn't state the exact number of experts involved or their specific qualifications (e.g., "Radiologist with 10 years of experience").
4. Adjudication method for the test set
The primary efficacy endpoint (revascularization success) was assessed by an "independent Core Lab." The primary safety endpoint (procedure-related serious adverse events) was adjudicated by an independent clinical events committee per protocol. The specific method of adjudication (e.g., 2+1, 3+1) for either endpoint is not detailed.
5. 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 study. This clinical trial evaluated the efficacy and safety of a medical device (thrombus retriever) for ischemic stroke treatment, comparing it directly to a predicate device. It did not involve AI assistance or human reader performance evaluation in diagnosing or interpreting medical images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, this evaluates a physical medical device (thrombus retriever), not an algorithm or AI. Therefore, a standalone algorithm performance study is not applicable.
7. The type of ground truth used
The ground truth for efficacy was angiographic data interpreted by an independent Core Lab using the Thrombolysis in Cerebral Infarction (TICI) score. For safety, the ground truth was occurrence of procedure-related serious adverse events adjudicated by an independent clinical events committee.
8. The sample size for the training set
- Not applicable. This study is a clinical trial evaluating the performance of a physical medical device, not a machine learning model, so there is no "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI/ML model.
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