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The Concentric Retriever is indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vascular systems.

The Concentric 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.

The provided text describes a 510(k) submission for a medical device, the "Modified Concentric Retriever." This submission aims to demonstrate substantial equivalence to a predicate device, not to establish performance against specific quantitative acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study details, and expert involvement is not present in the provided document.

Here's a breakdown of what can be extracted and what is not available based on the input:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. The document describes non-clinical testing for substantial equivalence, not a clinical study with a test set of patient data. The "tests" mentioned are likely bench or in-vitro tests on the device itself.

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

Not applicable. This information pertains to studies establishing ground truth, typically for AI/imaging devices, which is not the subject of this 510(k) submission.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of a "test set" in the context of clinical data requiring adjudication.

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. This device is a medical tool (catheter) for foreign body retrieval, not an AI or imaging diagnostic device.

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.

7. The Type of Ground Truth Used

Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this device would be its ability to physically perform its intended function (retrieval of foreign bodies) without failure or adverse events, as demonstrated through engineering and bench testing.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI or machine learning model that requires a "training set."

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

Not applicable.

Summary based on the document:

The 510(k) submission for the "Modified Concentric Retriever" focuses on demonstrating substantial equivalence to an existing predicate device (Concentric Retriever K003410). This is a regulatory pathway that allows devices to be marketed without requiring new clinical trials if they are shown to be as safe and effective as a legally marketed device.

The "study" that proves the device meets the (implied) acceptance criteria of substantial equivalence consists of non-clinical testing. The document states that "The modified Concentric Retriever was tested in the same manner as the predicate Concentric Retriever (K003410). All components, subassemblies, and/or full devices met the required specifications for the completed tests." This suggests that the device underwent rigorous engineering and performance testing (e.g., mechanical integrity, functional testing in simulated environments) to ensure it performs identically or equivalently to the predicate device.

The information provided does not include details about specific quantitative acceptance criteria or the specifics of these "required specifications" or the "completed tests," nor does it involve clinical studies with human subjects, expert review, or AI performance metrics.

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