(62 days)
Parallax® Acrylic Resin with TRACERS® is indicated for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myleoma).
Parallax® Acrylic Resin with TRACERS® is an opacified polymethylmethacrylate bone cement.
The provided text is a 510(k) summary for the ArthroCare Corporation Parallax® Acrylic Resin with TRACERS® bone cement, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not contain information about the performance criteria, a detailed study with specific acceptance criteria, or the types of information requested in the prompt (e.g., sample sizes for test/training sets, expert qualifications, HRMR studies, etc.).
Instead, the document asserts substantial equivalence based on:
- Indications for Use
- Materials
- Mechanical properties
- Performance testing (details not provided)
Therefore, I cannot extract the requested information from the provided text. The document states "performance testing has been completed to demonstrate the substantial equivalence," but it does not describe the specific acceptance criteria, test methodology, or results in a way that would allow me to populate the requested table or answer the specific questions about study design elements.
§ 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.”