Search Results

The Captix Foreign Body Retriever is 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 Captix Retriever consists of a flexible, tapered core wire with a shaped section at the distal end. A platinum coil at the distal end allows fluoroscopic visualization. Retriever dimensions are indicated on the product label. The Retriever has a hydrophilic coating to reduce friction during use. A torque device and an insertion tool are provided with the Retriever.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for a medical device (Captix™ Retriever) and describes its intended use, predicate device, materials, and a general summary of verification and validation testing.

However, it does not provide:

• A table of acceptance criteria and reported device performance with specific metrics.
• Sample sizes for test sets, data provenance, or details on ground truth establishment (experts, adjudication methods).
• Information on multi-reader multi-case (MRMC) studies or standalone algorithm performance.
• Sample size or ground truth details for a training set, as this is not an AI/ML device.

The "Testing Summary" section broadly states that the device conforms to pre-determined specifications and confirms substantial equivalence to a predicate device, but it lacks the detailed quantitative information you've requested regarding acceptance criteria and performance against those criteria. The tests mentioned (e.g., kink resistance, tensile, radiopacity, retrievability, in-vivo animal testing) are general categories of engineering and biological performance, not specific acceptance criteria in the format you've outlined.

Therefore, I cannot provide the requested table and detailed study information based on the given text.

Ask a specific question about this device