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The Concentric Retriever is indicated for use in the retrieval of foreign bodics 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 radiopaque distal coil facilitates fluoroscopic visualization.

The provided text describes a 510(k) premarket notification for a medical device called the "Concentric Retriever." However, it does not contain information about acceptance criteria or a study designed to prove the device meets those criteria.

The document's purpose is to demonstrate substantial equivalence to a predicate device, not to establish new performance criteria or conduct a de novo study to prove a device meets specific performance metrics.

Specifically, the document states:

• "The modified Concentric Retriever was tested in a similar manner as the predicate Concentric Retriever (K003410, K030476). All components, subassemblies, and/or full devices met the required specifications for the completed tests." This indicates that the testing was primarily to ensure the modified device performed similarly to the predicate and met its existing specifications, not to establish new acceptance criteria or conduct a new clinical or performance study to prove efficacy or safety against such criteria.
• "The modified Concentric Retriever is equivalent to the predicate product, the Concentric Retriever. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent." This is the core argument for a 510(k) submission, confirming equivalence rather than proving performance against specific acceptance criteria with a dedicated study.

Therefore, I cannot provide the requested information about acceptance criteria, device performance, study details (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set) because this information is not present in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device via manufacturing and materials comparisons and limited "similar manner" testing, rather than a detailed performance study with defined acceptance criteria.

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