(147 days)
The XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is intended for delivery of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement, which is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma).
XeliteMed VertehighFix High Viscosity Spinal Bone Cement System is divided into two parts, bone cement and a delivery system.
Bone cement is provided as a two-component system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use.
The delivery system consists of a bone cement mixing device and a hydraulic pump. The Bone Cement Mixing Device can mix and stir the powder and liquid and transfer it to the injection barrel. Then, the bone cement is extruded and injected into the vertebral body by the hydraulic pump.
This FDA clearance letter pertains to a bone cement system and its delivery system, not an AI/ML powered device. As such, the typical acceptance criteria and study descriptions relevant to AI/ML devices (e.g., sensitivity, specificity, MRMC studies, expert adjudication) are not present in this document.
The provided text focuses on the substantial equivalence of the XeliteMed VertehighFix High Viscosity Spinal Bone Cement System to a predicate device, primarily based on its materials, indications for use, and pre-clinical testing for the delivery system.
Therefore, I cannot extract the requested information regarding acceptance criteria and studies for an AI/ML device from this document. The information presented is for a traditional medical device (bone cement and its delivery system).
§ 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.”