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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.

Like the predicate devices, the design of the modified Merci Retrievers consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filaments are attached to the distal end. The core wire proximal to the helix is coated with a hydrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcather during the procedure. Merci Retrievers with "DOC" Compatible" shown on product label are compatible with the Abbott Vascular DOC® Guide Wire Extension.

This 510(k) premarket notification for the Merci Retriever focuses on a device modification and does not include a study describing acceptance criteria and device performance in the way a clinical trial or performance study for a new diagnostic or prognostic device typically would.

The document indicates that the device modification is for the Merci Retriever, which is an endovascular thrombus retriever. The modified device's intended use and materials are the same as the predicate devices. The substantial equivalence determination is based on the modified device having the same intended use and materials as previously cleared devices. Therefore, the information typically requested about acceptance criteria and study design for proving performance is not present in this type of submission.

Here's an breakdown of the requested information, indicating why it's not applicable or present in this specific 510(k) submission:

1. A table of acceptance criteria and the reported device performance

Not applicable/provided. This 510(k) is for a device modification, relying on substantial equivalence to predicate devices for its safety and effectiveness. It does not present new performance data against specific acceptance criteria for a novel device. The "performance" is implicitly considered equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable/provided. No new clinical or performance study involving a test set is detailed in this 510(k) for the modified device.

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)

Not applicable/provided. There is no new test set or ground truth establishment described for this device modification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/provided. No new test set or adjudication process is described.

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

Not applicable/provided. This device is a mechanical thrombus retriever, not an AI-assisted diagnostic or prognostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable/provided. This device is a mechanical thrombus retriever, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable/provided. No new ground truth is established for this device modification.

8. The sample size for the training set

Not applicable/provided. This is a mechanical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

Not applicable/provided. Not applicable as this is not a machine learning model.

Summary:

This 510(k) submission (K090085) for the Merci Retriever is a "Special 510(k): Device Modification." Such submissions typically demonstrate substantial equivalence to a predicate device based on design, materials, and intended use remaining largely the same, or minor changes not affecting safety or effectiveness. They do not usually include new clinical studies or elaborate performance data as would be found for an entirely new device or one requiring significant performance validation. The FDA's substantial equivalence determination ("We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...") confirms this approach.

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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.

Like the predicate device, the design of the modified Merci Retriever consists of a flexible, tapered Nitinol core wire. This distal end is shaped into a helix and a platinum coil is threaded over and attached to the distal end. Polymer filiaments are attached to the distal end. The core wire proximal to the helix is coated with a fordrophilic coating. A torque device is provided with Retriever to facilitate manipulation. An insertion tool is provided with Retriever to introduce Retriever into Microcatheter during the procedure.

I am sorry, but the provided text does not contain information about acceptance criteria and the results of a study as you requested. The document describes a 510(k) submission for a modified Merci Retriever device, focusing on its substantial equivalence to a predicate device. It briefly mentions "design verification and validation testing" confirming conformity to "required specifications," but it does not detail these specifications as acceptance criteria or present specific outcomes of a study that would demonstrate the device meets them.

Therefore, I cannot populate the table or provide answers to the specific questions regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment.

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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."

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.

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