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Vertefix™ Radiopaque Bone Cement is indicated for the fixation of vertebral compression fractures during a vertebroplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

The Vertefix™ Vertebroplasty Procedure Set contains the Vertebroplasty Injector Kit and Vertefix™ Radiopaque Bone Cement. The bone cement consists of two separate, premeasured sterilized components: 20g polymer powder and 9.2g liquid monomer. The powder contains 30% barium sulfate as a radiopacifier.

This 510(k) submission for the Vertefix™ Vertebroplasty Procedure Set focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study with specific acceptance criteria and performance metrics for a novel AI/software medical device.

Therefore, many of the requested details, such as specific acceptance criteria, a test set with expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable or not provided in this document. This submission primarily relies on non-clinical testing to demonstrate that the device meets existing standards for bone cement.

Here's the information that can be extracted or deduced from the provided text, with clarifications where details are missing:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a bone cement device, the "acceptance criteria" are not reported as quantitative performance metrics for disease detection or classification, as would be expected for an AI device. Instead, they are related to material properties and clinical equivalence. The document states:

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

• Sample Size: Not applicable. This submission doesn't describe a clinical study with a "test set" in the context of an AI/software device evaluating patient data. The "testing" refers to benchtop and laboratory tests on the bone cement itself.
• Data Provenance: Not applicable. The data provenance would be from laboratory and benchtop studies, not patient data from specific countries or types of studies.

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

• Number of Experts: Not applicable. There is no "ground truth" derived from experts on patient data described in this submission.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set

• Adjudication Method: Not applicable. There is no test set of patient cases requiring adjudication.

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

• MRMC Study: No. This is not an AI-assisted device.
• Effect Size: Not applicable.

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

• Standalone Performance: No. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not applicable in the context of clinical outcomes or diagnostic accuracy. The "ground truth" for this device would be established by validated engineering standards, chemical analyses, and biomechanical testing protocols for bone cements.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Ground Truth for Training Set: Not applicable.

Summary of the Study (Non-Clinical Test Data):

The study described is a series of non-clinical tests designed to demonstrate the safety and effectiveness of the Vertefix™ Radiopaque Bone Cement.

• Tests Conducted: Material and chemical analyses, mechanical testing, and biocompatibility testing.
• Purpose: To provide reasonable assurance that the device conforms to the requirements for its use as a bone cement and is substantially equivalent to legally marketed predicate devices (Stryker Spineplex™ Radiopaque Bone Cement and Kyphon KyphX® HV-R Bone Cement Model C01A).
• Conclusion: The tests support the claim of substantial equivalence and that "any differences that may exist do not significantly affect the safety and effectiveness of the device."

This document focuses on the regulatory pathway for a conventional medical device (bone cement) based on its physical and chemical properties and comparison to existing products, rather than the performance evaluation of a software-based or AI-driven diagnostic/therapeutic system.

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