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The PowerPro™ Battery System functions as a powered instrument system consisting of handpieces and accessories to perform cutting of soft tissue and bone. The fields of application include orthopedic procedures such as osteotomies, small and large bone trauma, orthopedic reconstruction, and total joint replacement, neurosurgical fusion and plating procedures, and medial sternotomy.

The PowerPro Battery System also includes a sterilization case to enclose the rechargeable batteries during sterilization, and also to maintain sterility of the batteries until used.

The PowerPro Battery System is a powered instrument system consisting of various pistol-grip handpieces, universal battery charger, rechargeable batteries and sterilization trays. The handpieces utilize various attachments, such as blades, burs, drills and routers.

This document is a 510(k) premarket notification for the PowerPro™ Battery System. It establishes substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot fulfill your request to create:

1. A table of acceptance criteria and the reported device performance
2. Sample sized used for the test set and the data provenance
3. Number of experts used to establish the ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results
6. Standalone performance results
7. Type of ground truth used
8. Sample size for the training set
9. How the ground truth for the training set was established

This document focuses on regulatory approval through substantial equivalence, not on detailed performance studies with acceptance criteria.

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