Search Results

The Universal Mesh is indicated for reconstruction, stabilization subsequent to craniotomy, craniectomy, cranioplasty, and cranial fractures in adults and adolescents (age 12 and higher).

The Stryker Universal Mesh consists of mesh implants in different shapes, thicknesses and perforation patterns which include the 1.2mm and 1.5/ 1.7mm Dynamic Mesh implants and Hybrid Mesh implants. The meshes can be modified with trimming and bending instruments for an anatomical fit and are malleable for three-dimensional adaptations. The necessary instrumentation for mesh modification, Mesh Cutter (coarse), Mesh Step Bender, and the Mesh Clipper are included with the system. The Stryker Universal Mesh implants are provided nonsterile and are for single use only. The instrumentation and storage system is reusable.

Also, the mesh can be fixated to the bone with screws available in previously marketed Stryker CMF implant systems. The previously marketed screws are not specifically packaged with the subject device, but the implant tray of the Universal Mesh Storage system contains space to store the screw disc if that option is chosen.

The provided document describes the Stryker Universal Mesh, a cranioplasty plate, and its substantial equivalence determination by the FDA. However, the document does not contain information related to an AI/ML device. Therefore, it does not include studies with acceptance criteria for device performance, sample sizes for test or training sets, expert ground truth establishment, adjudication methods, or MRMC studies.

The document focuses on non-clinical performance testing for a medical device (cranioplasty plate) made of titanium, assessing its biocompatibility, reprocessing, cleaning, sterilization, mechanical performance, corrosion, and MR compatibility. These tests are standard for a physical medical device and do not involve AI/ML.

Given the absence of information regarding an AI/ML device, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/ML context.

Ask a specific question about this device