(184 days)
The Modified Merci Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing an 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 Modified Merci Retriever is also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.
Like the predicate device, the Modified Merci Retriever consists of a flexible, Nitinol core wire with shaped distal loops covered by a platinum coil for radiopacity. It is coated with a hydrophilic lubricious coating.
Both the Modified Merci Retriever and the predicate device are placed distal to the thrombus or foreign body using a microcatheter which is retracted to deploy the loops of the Retriever. The Retriever and microcatheter are pulled back into the thrombus or foreign body, engaging it in the loops of the Retriever. The Retriever, the thrombus or foreign body, and the microcatheter are then removed from the body.
The provided text is a 510(k) summary for the Modified Merci® Retriever. It details the device's description, intended use, and its substantial equivalence to a predicate device. However, it does not include information about specific acceptance criteria or the details of a study that proves the device meets such criteria in terms of performance metrics like sensitivity, specificity, or outcomes.
This document focuses on demonstrating substantial equivalence to a previously cleared device (Merci® Retriever X6) through materials and testing methods. It states: "The Modified Merci Retriever was tested in the same manner as the predicate device. All devices met the required specifications for the completed tests." This implies that the 'acceptance criteria' were likely internal engineering specifications for the device's physical properties and function, rather than clinical performance metrics in a study.
Therefore, most of the information requested in your prompt cannot be extracted from this document, as it pertains to clinical study design and performance evaluation, which is not present here.
Here's what can be answered based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not explicitly list acceptance criteria (e.g., target thrombus removal rates, recanalization success, complication rates) or reported performance metrics in a clinical context. It only states that all devices "met the required specifications for the completed tests," which refers to product-level engineering tests, not clinical performance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided. A clinical "test set" and its provenance are not mentioned.
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):
- Cannot be provided. This information would be relevant to a clinical study, which is not detailed in this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. This is relevant to a clinical study.
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:
- Cannot be provided. This device is an endovascular retriever, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is a physical medical instrument, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. Ground truth is a concept for evaluating diagnostic or imaging systems against a definitive reference. This document for a physical medical device does not discuss such ground truth in relation to performance.
8. The sample size for the training set:
- Cannot be provided. This would be relevant for an AI/machine learning model, which this device is not.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable to this type of device submission.
Summary of what is available from the text relevant to testing:
- Testing Approach: The Modified Merci® Retriever was tested "in the same manner as the predicate device."
- Outcome of Tests: "All devices met the required specifications for the completed tests."
- Quality System: The device was designed under the Concentric Quality System, which complies with 21CFR8820.30.
This submission relies on demonstrating "substantial equivalence" to a predicate device (Merci® Retriever X6), implying that if the new device performs comparably in engineering design and materials, and meets similar specifications, it is considered safe and effective for similar indications. The document does not contain the level of detailed clinical study data often found for new devices or AI/diagnostic tools.
§ 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).