(214 days)
The StaXx™ FX System is indicated for use in the reduction of spinal fractures. It is intended to be used in combination with Stryker Spineplex™ Radiopaque Bone Cement.
The StaXx™ FX System is a vertebral fracture reduction device composed of stackable wafers fabricated from preformed PMMA. The System includes a base wafer fabricated from PEEK-OPTIMA with 6% Barium Sulfate. The wafers are designed to be inserted incrementally into the vertebral body to form a column that provides the desired fracture reduction. Twenty-four wafers are provided per package. The wafers are provided in one width (8mm) with three lengths (20mm, 25mm, 30mm)
The provided text is a 510(k) summary for the StaXx™ FX System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about specific acceptance criteria or a study proving the device meets them in the way described in the prompt's request for clinical performance metrics (e.g., sensitivity, specificity).
The document states:
"In addition, mechanical testing demonstrated that the StaXx™ FX System meets the performance requirements for its intended use. Any differences between the StaXx™ FX and the predicate devices do no affect the safety or effectiveness of this device."
This indicates that mechanical testing was performed to show the device meets performance requirements, but the specific acceptance criteria and the results of that testing are not detailed in this 510(k) summary. The summary focuses on comparing the new device to existing predicate devices to establish substantial equivalence based on intended use and mechanical properties, not on clinical performance metrics like accuracy, sensitivity, or specificity that would come from a study involving human readers or expert ground truth.
Therefore, I cannot provide the requested table or detailed information on specific acceptance criteria, sample sizes, expert ground truth, or reader studies because this information is not present in the provided text.
The requested information cannot be extracted from the provided text.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”