(78 days)
The Modified 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 Modified Trevo Retriever 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. A radiopaque coil at the distal end and new radiopaque platinum wires in the shaped section 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 a 510(k) premarket notification for a medical device called the "Modified Trevo Retriever." This submission aims to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy against specific acceptance criteria for a new clinical indication. Therefore, the information typically associated with acceptance criteria for a medical AI device, a study design to meet those criteria, and the detailed statistical results expected for such a study is not present in the provided document.
The document focuses on demonstrating that modifications to an existing device (the Trevo Retriever) do not raise new questions of safety or effectiveness, and that the modified device performs as designed and is substantially equivalent to the predicate.
Here's an analysis based on the provided text, addressing your questions to the extent possible:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a modified device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity, specificity, or image quality, but rather in terms of engineering and functional performance relative to the predicate device. The performance is assessed through various physical and simulated use tests.
| Acceptance Criteria (Implied by Testing) | Reported Device Performance |
|---|---|
| Ability to be used in a neurovascular model per procedural instructions | Successfully evaluated (Simulated Use Testing) |
| Mechanical integrity under tensile loads | Successfully evaluated (Tensile Testing) |
| Resulting radial force when constrained radially | Successfully evaluated (Radial Force Testing) |
| Force to deflect the distal tip | Successfully evaluated (Tip Deflection Force Testing) |
| Ability to withstand torque and tensile load cycles without fracture | Successfully evaluated (Torque/Tensile Durability Testing) |
| Ability of the device shaft to resist kinking | Successfully evaluated (Kink Resistance) |
| Platinum wire and joint integrity following loading cycles | Successfully evaluated (Platinum Wire and Joint Durability) |
| Platinum wire attachment strength | Successfully evaluated (Platinum Wire Attachment) |
| Visibility of the platinum shaped section under fluoroscopy during use | Successfully evaluated (Radiopacity) |
| Substantial equivalence to the predicate device in design, materials, use | Demonstrated through testing; no new safety/effectiveness issues identified |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify sample sizes (e.g., number of devices tested for each engineering test). It also does not mention data provenance in terms of country of origin or whether any prospective/retrospective clinical data was used, as the testing described is primarily bench and simulated use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the provided document. The "ground truth" here is based on engineering specifications and successful completion of physical and simulated performance tests, not on expert clinical review of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to the provided document. Adjudication methods are typically used in clinical studies involving human reviewers to establish a consensus ground truth for diagnostic decisions. The testing described is physical and simulated.
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 such study was done or mentioned. This document pertains to a physical medical device (thrombus retriever), not an AI-powered diagnostic or assistive technology.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluated is based on established engineering principles, material science, and the ability of the device to meet predefined functional specifications (e.g., in terms of tensile strength, radial force, visibility). For "simulated use testing," the ground truth would be the ability to successfully complete the procedure according to the Instructions for Use in a model.
8. The sample size for the training set
This question is not applicable, as there is no "training set" in the context of this physical device submission.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 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).