Search Results
Found 1 results
510(k) Data Aggregation
(257 days)
MERCI RETRIEVER, MODELS 90065, 90066
The Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke. Patients who are ineligible for treatment with intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment. The Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
The Merci Retriever consists of a Nitinol tapered wire with a helical shaped distal tip. A platinum coil is attached over the helical distal tip. A radiopaque distal coil facilitates fluoroscopic visualization.
This document describes the 510(k) premarket notification for the Concentric Merci® Retriever Models X5 and X6. The information provided is directly from the submitted summary and FDA clearance letter.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes the predicate device equivalence and testing, but does not explicitly state specific quantitative acceptance criteria or detailed performance metrics against those criteria. It uses language indicating that the device "met the required specifications" and that "no new issues of safety and effectiveness exist."
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Safety and Effectiveness | No new issues of safety and effectiveness | "The MERCI Clinical Study established that no new issues of safety and effectiveness exist when the Merci Retriever is used for thrombus removal versus foreign body removal from the neurovasculature." |
| Predicate Equivalence | Substantially equivalent to predicate device (Concentric Retriever K030476) in indications for use, function, methods of manufacturing, and materials. | "The Merci Retriever is equivalent to the predicate device, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent." |
| Specifications | Met required specifications for all components, subassemblies, and/or full devices. | "All components, subassemblies, and/or full devices met the required specifications for the completed tests." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions a "MERCI Clinical Study" but does not specify the sample size for this study.
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. Clinical studies for medical devices typically involve prospective data collection, but this is not confirmed here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information regarding the number of experts used or their qualifications for establishing ground truth within the MERCI Clinical Study.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method used for the test set in the MERCI Clinical Study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned in the provided document. The submission focuses on device clearance through substantial equivalence and a clinical study assessing safety and effectiveness, not direct comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This device is a physical medical device (a catheter for thrombus retrieval), not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable to this submission.
7. Type of Ground Truth Used
The document refers to a "MERCI Clinical Study" that established safety and effectiveness for "thrombus removal versus foreign body removal." This suggests that the ground truth would have been based on clinical outcomes data related to successful thrombus removal, restoration of blood flow, and potentially adverse events, as observed and documented during clinical procedures. Pathology or expert consensus on images alone would likely not be sufficient for assessing the performance of a physical retrieval device.
8. Sample Size for the Training Set
The concept of a "training set" typically applies to machine learning algorithms. Since the Merci Retriever is a physical medical device, there is no explicit "training set" in the context of AI development. The device's design, manufacturing, and preclinical testing would involve various engineering and bench testing data, but not an AI training set.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no AI training set for this physical device. Therefore, this question is not applicable. The device's "ground truth" during its development would have been established through a combination of engineering specifications, material testing standards, and preclinical (in vitro and in vivo) performance evaluations against defined mechanical and functional requirements.
Ask a specific question about this device
Page 1 of 1