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The Alligator™-HD Retrieval Device is intended for use in the peripheral, neuro and cardiovasculature for foreign body retrieval.

The Alligator™-HD Retrieval Device (ARD-HD) is a retriever with grasping jaws attached to the tip of a flexible wire. The device is designed to be used in conjunction with an off-the-shelf 0.21 in. (0.51mm) ID (inner diameter) microcatheter. The grasping jaws and the distal end of the ARD-HD device are made of radio opaque material facilitating fluoroscopic visualization. The ARD-HD is for single use only.

The provided text is a 510(k) summary for the Alligator™-HD Retrieval Device. It is a submission for a medical device to demonstrate substantial equivalence to a legally marketed predicate device, not a clinical study report of a new device's performance against detailed acceptance criteria.

Therefore, the document does not contain the following information:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes for a test set, data provenance, or ground truth establishment for a diagnostic algorithm.
• Information on expert panels (number, qualifications, adjudication methods) for establishing ground truth.
• Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
• Sample size for training sets or how their ground truth was established.

The document focuses on demonstrating substantial equivalence to predicate devices based on design, function, manufacturing, materials, indications, packaging, sterilization, and labeling. It explicitly states that "The information presented in the 510k shows that the Alligator™-HD Retrieval Device, ARD-HD is substantially equivalent to predicate endovascular snare devices in regards to the following aspects."

This type of submission typically relies on non-clinical performance data (e.g., bench testing, biocompatibility, sterilization validation) to support the safety and effectiveness claims, rather than clinical efficacy studies with human subjects and diagnostic performance metrics like sensitivity, specificity, or reader improvement.

In summary, the provided text does not describe a study that proves the device meets specific acceptance criteria in the way a diagnostic AI device would. Instead, it argues for substantial equivalence to existing devices.

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