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OSTEOPAL® plus 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® plus is a radiopaque, low-viscosity bone cement, based on polymethyl methacrylate with an extended application phase, used to fill and stabilize vertebral bodies. OSTEOPAL® plus contains zirconium dioxide as an X-ray contrast agent. OSTEOPAL® plus contains the coloring agent chlorophyll VIII (E141) to improve visibility in the surgical field. The bone cement is prepared immediately prior to use by mixing the polymer powder component and the liquid monomer component. A low viscosity paste is applied with the use of application system, placed in the vertebral body, where it cures. OSTEOPAL® plus conforms to ISO 5833.

This document describes the FDA's clearance of OSTEOPAL® plus, a polymethylmethacrylate (PMMA) bone cement, based on its substantial equivalence to a predicate device (OSTEOPAL® V). The information provided does not detail an AI-powered device or a study involving AI performance. Instead, it focuses on the materials science and biocompatibility of the bone cement.

Therefore, many of the requested fields related to AI device performance are not applicable based on the provided text.

Here's a breakdown of the requested information based on the provided document:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance:

• Sample size: Not applicable/Not provided. The document describes non-clinical laboratory testing of material properties, not a clinical study with human subjects or a test set for an AI algorithm.
• Data provenance: Not applicable/Not provided in terms of country of origin for a "test set." The testing was conducted by Heraeus Medical GmbH in Germany. The data is from laboratory testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. This device is not an AI algorithm and does not rely on expert-established ground truth for its performance assessment in this document. Its performance is assessed against material standards.

4. Adjudication method for the test set:

• Not applicable. This device is not an AI algorithm and does not involve adjudication of a test set.

5. 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:

• No. This is not an AI-powered device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• No. This is not an AI-powered device.

7. The type of ground truth used:

• Material Standards & Benchmarking: The "ground truth" for this device's performance is established by recognized international standards (ISO 5833 for bone cement properties, ISO 11135 for sterilization, ISO 10993 for biocompatibility) and comparison to a legally marketed predicate device (OSTEOPAL® V). For genotoxicity, it was based on the transferability of results from a predicate's predicate (PALACOS® R) due to shared material constituents.

8. The sample size for the training set:

• Not applicable. This is not an AI-powered device and therefore does not have a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI-powered device and therefore does not have a training set.

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