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510(k) Data Aggregation
K Number
K061224Device Name
LAPDOC I
Manufacturer
Date Cleared
2006-09-05
(127 days)
Product Code
Regulation Number
882.4560Why did this record match?
Applicant Name (Manufacturer) :
ROBODENT GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Lapdoc navigation system is a computerized navigational system intended to provide assistance in both the preoperative planning and the intra-operative surgical phases of dental implantation surgery. The system provides precise navigational guidance of surgical instruments such as a dental bur, with regard to the pre-operative planning in the dental implantation procedure.
Device Description
The Lapdoc System is a computer based assistance system for dental implantologists. It supports surgeons during planning and execution phase of dental implant procedures by providing highly precise quiding assistance during the implantation process within the human jaw. The systems supports the surgical implantation process by providing visual guidance for position and orienting of a dental bur relative to a planned implant position.
The Lapdoc system is designed to support clinicians by decreasing complication rates of surgical interventions in the field of dental implantology. Using the system will allow precise orientation of the surgeon within the human jaw both in the medical image model of the jaw during the planning phase as well as in real anatomy during the execution phase. This is achieved by objective measuring the spatial positions of surgical instruments and the patients anatomy. Based on three dimensional medical image data, the surgeon plans an intervention by virtually placing models of implants within the graphical depiction (of the medical image set) of the jaw. The surgeon views and interprets the medical images which are graphically augmented with the computer models of the implants. It is further possible to manually mark the outlines of sensitive anatomical structures (i.e. nerves) within the medical images. To perfectly understand the geometric dimensions of the patients anatomy and the later intervention, a three dimensional model is created from isodense surfaces in the CT images and displayed on the computer screen. Lapdoc uses the geometric information of the planned implants within the medical images to generate highly precise information to guide the surgeon's instrument directly to the intended implant position and orientation.
An optical measurement system consisting of an infrared-based stereo camera system and a set of two rigid structures (also known as rigid bodies or trackers) with attached reflectors is used to measure the spatial positions of the patient and the instruments. Therefore, the trackers are reproducible attached to the patient (using a dental splint) and to the surgical bur (using a cone nut connector). The stereo camera system comprises an internal position measurement processor and is connected to the Lapdoc computer. It senses the positions of the instruments and the patients tracker and communicates it to the Lapdoc computer. The computer calculates in real time the deviation between the actual and the desired (from the planning phase) transformation of the positions of both trackers. The actual bur position and the planned implant position and orientation are graphically displayed to the surgeon using a mini-display is placed within the vicinity of the surgeon and near the patient's mouth. The surgeon minimizes this deviation during the drill procedure by moving the bur in a way, that position and orientation of both the dental bur and planned implant are congruent. The system supports the surgeon by actieving a highly precise surgical outcome according to the planned scenario.
Lapdoc system will graphically and audibly signal to the surgeon, if the plan is fulfilled and the surgical bur has reached its designated position and orientation. It will further warn the surgeon by reaching a minimal proximity value close to sensitive anatomical structures (i.e. nerves) and therefore avoids injury of such structures. Lapdoc is specifically designed to minimize the interaction between the user and the system. The application of the system follows simple ergonomic rules. The usage and working principle is easy to understand by the surgeon. The clinical workflow is not altered using Lapdoc.
To describe the patients anatomy and the medical image model in one common coordinate system, it is necessary to perform an image registration process. This registration process comprises a navigation bow of known geometry and an algorithm to detect and measure the position of the navigation bow within the medical image data set. Lapdoc correlates the positions of the navigation bow within the image data with its measured spatial position. Since the navigation bow is attached reproducible to the patients jaw by click-snaping it onto the patient's teeth, positions on or within the patients anatomy can also be described within the medical image data set using the registration function.
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