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InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).

Both the unmodified predicate and the subject modified InterV Kyphoplasty Catheter are designed for use in balloon kyphoplasty; they come as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component.

The provided FDA 510(k) summary does not describe a study involving an AI/CAD/software device, nor does it present acceptance criteria and performance for such a device.

The document is for a medical device called the "InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini)," which is a physical device used in surgical procedures. The summary focuses on comparing the modified version of this catheter to a previously cleared predicate device, demonstrating substantial equivalence based on mechanical and functional testing.

Therefore, I cannot extract information related to acceptance criteria and study details for an AI-powered device from this document. The sections you requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to the type of device described in this 510(k) submission.

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