(195 days)
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.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.