(161 days)
The Trevo XP ProVue Retriever (6x25 mm) 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 XP ProVue Retriever (6x25mm) consists of a flexible, tapered core with a shaped section at the distal end. It is designed to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Radiopaque platinum wires in the shaped section and radiopaque markers on the distal end allow 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.
The provided text describes the Trevo XP ProVue Retriever (6x25 mm) and summarizes the testing conducted to support its substantial equivalence to a predicate device (Trevo XP ProVue Retriever (4x20mm)). However, it does not contain specific acceptance criteria for each test or detailed performance metrics in the format of a table comparing criteria to reported performance. Instead, it generally states that tests "meet acceptance criteria" or provides qualitative conclusions.
Therefore, for aspects requiring quantitative acceptance criteria and reported device performance (like a comparative table), a direct answer cannot be fully generated as that level of detail is not explicitly present. Similarly, information regarding sample size for test sets, data provenance, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance with specific metrics, or training set details are not provided in the given document.
Based on the available information, here's what can be inferred and stated:
1. A table of acceptance criteria and the reported device performance
The document lists various tests and provides a "Conclusions" column for each, generally stating that the device "meets acceptance criteria." It does not provide the numerical acceptance criteria themselves or quantitative reported device performance in most cases.
| Test | Acceptance Criteria (Not explicitly stated quantitatively in the document for most tests) | Reported Device Performance (Qualitative conclusions) |
|---|---|---|
| Dimensional Verification | Not specified quantitatively | Dimensional verification meets acceptance criteria. |
| Retriever Mid Joint Tensile Strength | Not specified quantitatively | Retriever Mid Joint Tensile Strength meets acceptance criteria. |
| Retriever Tip Tensile Strength | Not specified quantitatively | Retriever Tip Tensile Strength meets acceptance criteria. |
| Retriever Shaped Section Radial Force | Not specified quantitatively | Retriever Shaped Section Radial Force meets acceptance criteria. |
| Retriever/Vessel Interaction (Tip Flexibility) | Not specified quantitatively | Retriever/Vessel Interaction (Tip Flexibility) meets acceptance criteria. |
| Retriever Torque Tensile Durability | Not specified quantitatively | Retriever Torque Tensile Durability meets acceptance criteria. |
| Retriever Platinum Wire Joint Strength | Not specified quantitatively | Retriever Platinum Wire Joint Strength meets acceptance criteria. |
| Retriever Platinum Wire and Joint Durability | Not specified quantitatively | Retriever Platinum Wire and Joint Durability meet acceptance criteria. |
| Radiopacity | Visual assessment of device under fluoroscopy. | Radiopacity meets acceptance criteria. |
| Retriever / Microcatheter Deliverability | Not specified quantitatively | Retriever/Microcatheter Deliverability meets acceptance criteria. |
| Particulate Evaluation | Maximum allowable number/size of particulates generated during simulated use. | All samples meet acceptance criteria (i.e., total number and size of particulates generated were within limits for ≥10µm, ≥25µm, and ≥50µm size ranges). |
| Coating Integrity Evaluation | No delamination at coating edges, minimal defects along coating length after tracking. | Neither Baseline nor Post-tracking test articles exhibited delamination at coating edges. Baseline showed no defects; Post-tracking showed minimal defects. Coating functions as intended and exhibited appropriate integrity. |
| Simulated Use | Successful removal of simulated thrombus, no adverse events. | Simulated Use meets acceptance criteria (i.e., device successfully retrieved simulated thrombus in a neurovascular model). |
| Animal Studies (Acute) | No arterial transmural dissection or perforation due to Stentriever use. | Histopathology consistent with arterial healing after routine catheterization. Angiography showed no evidence of vessel dissection, perforation, or thrombosis. |
| Animal Studies (Chronic) | No arterial transmural dissection or perforation; no stenosis, vessel irregularity, or pseudoaneurysm at treatment sites. | Histopathology consistent with arterial healing. No evidence of vessel dissection or perforation. Angiography showed no evidence of dissection, perforation, stenosis, vessel irregularity, intimal flap, or pseudoaneurysm at Day 0 and Day 30. Animal studies meet acceptance criteria and are comparable to the predicate device. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for most tests.
- For Animal Studies: 12 test articles (devices) were deployed (4 per animal) across 6 treatment runs in both internal maxillary arteries (IMAs) of animals, resulting in the assessment of 6 arteries (2 per animal) for both acute and chronic studies.
- Data Provenance:
- Simulated Use: Conducted using a silicone neurovascular model cast from actual human neurovascular arteries.
- Animal Studies: Conducted in swine, in compliance with GLP regulation (21 CFR Part 58). This is prospective animal data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests primarily involve engineering performance metrics, simulated use outcomes, and animal study observations (angiography, histopathology) conducted by unspecified personnel. There is no mention of external human experts establishing ground truth for the test set in the context of diagnostic interpretation or similar tasks.
4. Adjudication method for the test set
This information is not provided in the document. The tests described are primarily physical/mechanical performance tests, simulated use, and animal studies. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in clinical or image-based diagnostic studies involving human interpretation.
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
There is no mention of an MRMC comparative effectiveness study, AI assistance, or human reader performance improvement in this document. The device is a mechanical thrombectomy retriever, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is a medical instrument (thrombectomy retriever) and not an algorithm or AI system. Its performance is inherent to the device itself (mechanical, physical, and biocompatibility characteristics), not an algorithm that operates standalone. The animal and simulated use studies demonstrate its "standalone" performance as a device.
7. The type of ground truth used
- For physical/mechanical tests (e.g., tensile strength, radial force, deliverability, particulate evaluation): The "ground truth" is defined by established engineering specifications and physical measurements, and compliance with these objective criteria.
- For Radiopacity: Visual assessment under fluoroscopy.
- For Coating Integrity: Visual assessment, comparison of test articles, and consideration of other correlated tests (lubricity, durability, particulate generation).
- For Simulated Use: The ability to retrieve simulated thrombus in a physical model, guided by procedural instructions derived from the Instructions for Use.
- For Animal Studies: Histopathology and angiography results are used to assess vessel response, dissection, perforation, thrombosis, stenosis, etc., against predefined safety criteria.
8. The sample size for the training set
This information is not provided and is not applicable to the type of device (a medical instrument). Training sets are typically associated with machine learning or AI models, which this device is not.
9. How the ground truth for the training set was established
This information is not provided and is not applicable for the same reasons as #8.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).