(305 days)
The Vertecem Bone Cement is used for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures of the vertebral body may result from osteoporosis, benign lesions (hemangioma), or malignant lesions (metastatic cancers, myeloma).
Vertecem is a self-hardening and ready to use bone cement with a high amount of radiopaque agent for percutaneous vertebroplasty. It allows an excellent consolidation of the vertebral body and an effective and rapid privation in this type of cement is made of two sterile components: the polymer in powder and the liquid monomer. These two components are in a double sterile packaging. Each unit contains a sterile ampoule of liquid within a blister pack and a powder within a double peelable pouch, the whole being packaged in a box.
The provided text is for a 510(k) summary for the Vertecem Bone Cement, a medical device. This type of document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
It describes the device, its intended use, and states that non-clinical tests were performed to show compliance with bone cement standards. However, it does not contain information about a study that used a test set of data, human readers, or addressed acceptance criteria related to diagnostic performance or accuracy.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and device performance based on the input document for the following reasons:
- No Acceptance Criteria for Diagnostic Performance: The document describes the "Vertecem Bone Cement" and its physical properties and intended use for fixing vertebral fractures. It doesn't mention any diagnostic function where acceptance criteria related to accuracy, sensitivity, specificity, or similar metrics would apply.
- No Diagnostic Study: The summary discusses "non-clinical tests" indicating the device's properties are stable and comply with bone cement standards. This refers to material science and mechanical testing, not a study evaluating diagnostic performance on a test set of data. There is no mention of a test set, ground truth, expert readers, or AI in this context.
- No "Device Performance" in the Requested Context: The device performance mentioned in the document relates to the stability and compliance of the bone cement material, not to a diagnostic outcome that would be compared against acceptance criteria in the way you've outlined.
The prompt's questions (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set information) are all relevant to the evaluation of diagnostic algorithms (e.g., AI in radiology). Since this document is about a bone cement product, these questions are not applicable to the submitted content.
§ 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.”