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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

The Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a quidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.

The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan.

Physical guidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, allowing the surgeon to grip the drill as normal. The Guidance Arm does not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling.

Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.

The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.

The NGS is a supporting device, providing additional information and quidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's iudgment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.

The subject device is the same as the NGS cleared under K161399 (the predicate device), except for a change to the splint. The Patient Splint of the predicate device has been modified to allow for a chairside workflow. This modified splint is referred to as the Chairside Splint.

The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using Lang Jet Tooth Shade Dental Acrylic (K083195). The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

The Neocis Guidance System (NGS) with Chairside Splint is a computerized navigational system intended to assist in planning and performing dental implantation surgery. The device provides software for pre-operative planning and navigational guidance for surgical instruments.

The acceptance criteria for the NGS, and the reported device performance, are as follows:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Clinical Test Set

• Sample Size: 75 subjects.
• Data Provenance: The document does not explicitly state the country of origin but implies a clinical study at two different sites. The study was prospective in nature, as it involved the application and removal of the Chairside Splint on subjects by investigators for evaluation.

3. Number of Experts and Qualifications for Clinical Test Set Ground Truth

• Number of Experts: 15 dentists.
• Qualifications of Experts: The document states "a variety of experience levels" for the investigator population. Specific years of experience or specializations (e.g., radiologist) are not provided.

4. Adjudication Method for Clinical Test Set

The document does not explicitly describe an adjudication method for the clinical test set data. It mentions "objective criteria and subjective criteria" for evaluation but not a process for resolving discrepancies if multiple assessors were involved in evaluating a single case/subject.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No mention of an MRMC comparative effectiveness study was made. The clinical study focused on human factors related to the Chairside Splint rather than comparing the effectiveness of human readers with and without AI assistance or quantifying an effect size of AI improvement.

6. Standalone (Algorithm Only) Performance Study

The document indicates that the NGS is a "computerized navigational system" and a "supporting device, providing additional information and guidance to the decision-making process during the surgical procedure. It is not intended to replace the surgeon's judgment." This strongly suggests that the device is designed for human-in-the-loop performance, and there is no mention of a standalone algorithm-only performance study. Accuracy metrics (System Lateral, Depth, and Angular Accuracy) are defined for the "System," implying the integrated device rather than an isolated algorithm.

7. Type of Ground Truth Used (Clinical Test Set)

The clinical study primarily focused on human factors related to the Chairside Splint application and removal. The "ground truth" for this aspect appears to be:

• Objective Criteria: Duration of application and removal, photos and intra-oral scans, occurrence of adverse events.
• Subjective Evaluation: Investigator assessments.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. The studies described are verification and validation efforts for the modified device (Chairside Splint) and the overall NGS system, rather than the development and training of a machine learning algorithm in the typical sense that would involve a distinct training set. The NGS, as described, is a navigational guidance system, not explicitly an AI diagnostic or predictive tool that undergoes a training phase with a labeled dataset.

9. How the Ground Truth for the Training Set Was Established

As no training set is described, the method for establishing its ground truth is not applicable or provided. The system's "accuracy" (lateral, depth, angular) is based on engineering verification and validation testing against known physical standards and simulated clinical scenarios.

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