Search Results

The fixation devices are designed to draw two or more bone fragments together in order to facilitate healing. The fixation devices are driven through the bone fragments using a powered rotary device. The fixation devices are typically left implanted in the body to provide fixation while the bone mends.

The subject devices (K-Wires and Steinmann Pins) are stainless steel fixation devices which draw bone fraqments together in order to facilitate healing. They will be supplied both as sterile and non-sterile devices and will be labeled for single use.

This document, K961522, is a 510(k) summary for Kirschner Wires (K-Wires) and Steinmann Pins. It describes the product, its intended use, and claims substantial equivalence to predicate devices.

However, the provided text DOES NOT contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any details related to AI/algorithm performance.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and the study that proves the device meets them based on the given input. The document is primarily a regulatory submission for a medical device and lacks the scientific study details you are asking for.

Ask a specific question about this device