Search Results

The VarioSurg device is intended for bone cutting in oral surgery, scaling and root planing, and retrograde preparation of root canals.

Not Found

This document is a 510(k) clearance letter from the FDA for the VarioSurg Bone Surgery System and Ultrasonic Scaler. It primarily focuses on regulatory approval and does not contain detailed information about acceptance criteria or a specific study proving the device meets them.

Therefore, I cannot provide the requested information. The document does not describe:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts, qualifications of experts, or adjudication methods.
• Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size.
• Whether a standalone performance study was done.
• The type of ground truth used.
• The sample size for the training set or how ground truth for the training set was established.

This document confirms regulatory clearance based on substantial equivalence to a predicate device, which is a different type of evaluation than a clinical or performance study that would establish and demonstrate adherence to specific acceptance criteria.

Ask a specific question about this device