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Cobalt™ V Radiopaque Vertebroplasty Bone Cement is indicated for the fixation of pathological fractures of the vertebral body due to osteoporosis, benign lesions and malignant lesions using a vertebroplasty or kyphoplasty procedure.

Cobalt™ V Radiopaque Vertebroplasty Bone Cement provides two separate, pre-measured sterilized components which when mixed form a radiopaque, rapidly setting bone cement.

The provided text focuses on the 510(k) summary for Cobalt™ V Radiopaque Vertebroplasty Bone Cement and does not contain detailed information about specific acceptance criteria, device performance metrics, or a formal study design with corresponding results.

Therefore, many of the requested fields cannot be filled. Based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance:
   The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." However, it does not provide specific acceptance criteria (e.g., tensile strength, setting time ranges) or numerical performance metrics.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
   No information is provided regarding sample sizes, data provenance, or the nature of the test set for any performance evaluation. The testing described is "non-clinical laboratory testing."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
   Not applicable. The document refers to non-clinical laboratory testing of a bone cement, not diagnostic image interpretation where expert ground truth would be established.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   Not applicable, as this refers to a medical device's performance in evaluating diagnostic results, which is not the case here.

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:
   Not applicable. This device is a bone cement, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   Not applicable. This device is a bone cement, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
   Not applicable. The testing was non-clinical laboratory testing of material properties, not an evaluation against a medical ground truth like pathology for a diagnostic device.

8. The sample size for the training set:
   Not applicable. This device is a bone cement, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established:
   Not applicable, as there is no training set for a bone cement device.

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