(295 days)
The Skeltex ISV is intended for percutaneous delivery of PMMA bone cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
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I'm sorry, but the provided text is a 510(k) summary letter from the FDA regarding a medical device called "Skeltex ISV," which is a PMMA bone cement. This document describes the FDA's substantial equivalence determination for this device, its intended use, and regulatory information.
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Therefore, I cannot fulfill your request using the provided text. To answer your questions, I would need a different document, such as a clinical study report, a scientific paper, or a more detailed technical document accompanying the 510(k) submission that describes the validation and testing of the device.
§ 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.”