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The NexGen Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arteries and veins, peripheral bypass grafts, and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

The MRD is a member of a family of sterile, single use, catheter-based devices that are intended to mechanically remove blood clots and other obstructions from blood vessels in the human body. The MRD is designed to be used for peripheral vascular applications.

The Device design is intended to allow easier access into anatomically difficult endovascular locations because it is pushed out of a small profile guide catheter. Other devices such as those delivering laser, ultrasound, or photo-acoustical energy may be too stiff to access tortuous blood vessels, and too large.

The MRD consists of a stainless steel coil that is inserted into a standard 4F guide catheter. The guide catheter is inserted into the vessel and past the occlusion using a standard guide catheter. Coils released from the MRD are then deployed distal to the occlusion. As the guide catheter is withdrawn, additional MRD coils are released proximal to the occlusion, thereby enmeshing the embolic material for removal.

This document describes the premarket notification (510(k)) for the NexGen Peripheral Mechanical Retrieval Device (MRD), a device intended for the removal of embolic/thrombotic material. The submission primarily relies on non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices, rather than clinical studies.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not available as well:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific quantitative acceptance criteria or detailed performance results from the bench tests. It lists the types of tests conducted to "verify the device met design specifications and its intended use." To create a table, we can list the tests performed, but without numerical criteria or outcomes, the "Reported Device Performance" would simply be a confirmation that the tests were passed.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document only mentions that "bench testing was conducted." The number of devices or iterations used for each test is not detailed.
• Data Provenance: The tests are categorized as "bench testing" and "in-vitro," indicating laboratory, non-clinical studies. There is no information regarding country of origin or whether the data is retrospective or prospective, as it's not a clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This was a non-clinical (bench and in-vitro) study. Ground truth in this context would refer to engineering specifications and performance metrics established during device design and testing, not typically clinical expert consensus.

4. Adjudication Method for the Test Set

Not applicable. Given this was non-clinical bench testing, an adjudication method for a test set (as typically seen in clinical studies with human assessors) is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a mechanical retrieval device, not an AI-assisted diagnostic or therapeutic device that would involve human readers or AI assistance.

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

Not applicable. This device is a physical medical instrument, not an algorithm or software-only device.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its 510(k) submission, is based on engineering specifications, design requirements, and a demonstration of mechanical and biological performance through bench and in-vitro testing. It relies on the device meeting predefined criteria for physical characteristics, functional performance in simulated environments (e.g., embolic removal in-vitro), and biocompatibility following ISO standards. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this submission, as "No clinical evaluations of this product have been conducted."

8. The Sample Size for the Training Set

Not applicable. As this is a mechanical medical device and not an AI/ML algorithm, there is no "training set" in the conventional sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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The NexGen Peripheral Mechanical Retrieval Device (MRD) is indicated for the removal of embolic / thrombotic material, including thrombus and debris, from peripheral arterial blood vessels and peripheral bypass grafts and the removal of thrombus from clotted synthetic dialysis grafts and arterio-venous fistulas.

Not Found

I am sorry, but the provided text primarily consists of an FDA 510(k) clearance letter for the NexGen Peripheral Mechanical Retrieval Device. It discusses the device's regulatory classification, product codes, and general compliance requirements.

However, the document does not contain any information about acceptance criteria or a study proving the device meets those criteria, nor does it provide details about clinical performance, test sets, expert involvement, or training data.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the necessary information is absent from the provided text.

Ask a specific question about this device