(454 days)
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partially or fully edentulous jaws.
Navident is an image-guided dental navigational system intended to assist with preoperative planning and real-time positioning of drilling tools during implantation surgery. In particular, Navident provides visual, real-time feedback on the location of the working tip of a dental handpiece. It shows the location and direction of the tip relative to a volumetric CT image of the patient's jaw registered to that anatomy, and, when available, relative to a path planned on that image. Navident is comprised of the following parts: The main system is comprised of a cart that carries a stereoscopic video camera and a laptop with pre-installed proprietary software. The Navident system also includes several types of accessories: Jaw motion Tracking Accessories, Dental Handpiece Tracking Accessories, Registration accessories, Calibrator. Navident's four core functions are: Model, Plan, Register, Guide.
Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:
Device: Navident
Product Code: PLV
Regulation Number: 21 CFR 872.4120
Regulation Name: Bone Cutting Instrument And Accessories
Regulatory Class: Class II
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on the performance data of the device rather than explicit "acceptance criteria" presented as pass/fail thresholds against specific metrics, except for the accuracy at the drill tip. Instead, it describes various validation and testing activities that collectively demonstrate the device's acceptable performance.
| Category | Acceptance Criteria / Standard (Implicit or Explicit) | Reported Device Performance / Study Finding |
|---|---|---|
| Reprocessing | Per AAMI TIR 30: 2011(R) 2016 for cleaning (Proteins |
§ 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.