(244 days)
OSTEOPAL® V bone cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a vertebroplasty or balloon kyphoplasty procedure.
Osteopal® V is an acrylic cement for use in vertebroplasty and kyphoplasty. It is formed from powder and liquid by exothermic polymerization.
This 510(k) summary for Osteopal® V, a PMMA bone cement, does not contain the kind of study information requested.
The document is a premarket notification for a medical device (bone cement) that is claiming substantial equivalence to a predicate device (Osteopal®) based on a change in a material characteristic (higher zirconium dioxide content for better X-ray contrast and lower viscosity). Therefore, the provided text describes the device, its intended use, and its comparison to a predicate device but does not include any studies related to its performance in terms of diagnostic accuracy or clinical effectiveness, which would typically involve acceptance criteria and performance data.
Specifically, the requested information elements are not present because this is a 510(k) submission for a physical device that is not an AI/ML diagnostic tool, and thus does not involve "acceptance criteria and reported device performance" in the way that an AI model would be evaluated.
Therefore, I cannot provide the requested information from the given text.
Here's why the specific questions cannot be answered:
- A table of acceptance criteria and the reported device performance: This document is about a material (bone cement) and its physical characteristics, not a diagnostic device with performance metrics like sensitivity or specificity.
- Sample size used for the test set and the data provenance: There is no "test set" in the context of an AI/ML algorithm being evaluated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.”