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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 quides surgeons during dental implant surgery (see Table 1 below for significant physical and performance characteristics details). 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 quidance 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 guidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's judgment. 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.

Here's a breakdown of the acceptance criteria and study information for the Neocis Guidance System (NGS), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies performance characteristics as acceptance criteria and also states a clinical study result.

Note: The document refers to "overall system accuracy (RMS) <1mm" in the comparison table and clinical results, encompassing lateral and depth accuracy, and implicitly angular accuracy.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 17 implants placed in 15 patients.
• Data Provenance: The document states "Clinical testing has been conducted...at three different surgical sites." It does not specify the country of origin, but generally FDA submissions imply studies conducted or accepted within the US or under comparable regulatory frameworks. The study was prospective as it involved clinical testing with patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: Three surgeons.
• Qualifications: No specific additional qualifications (e.g., years of experience, specific sub-specialty) beyond being "surgeons" were provided in this document.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth from multiple experts for the test set. The clinical study involved three surgeons, but the method for reconciling their assessments or determining a single ground truth is not detailed (e.g., whether it was based on consensus, majority rule, or if each surgeon's assessment of their own patient was considered ground truth).

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

No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not described. The clinical study focused on the feasibility and accuracy of the NGS for osteotomy preparation by surgeons using the system. It did not compare human performance with and without the device.

6. Standalone Performance Study

Yes, a standalone performance study was done for several components and the total system. The "Non-clinical Testing" section and "Software and System Verification and Validation" section describe various tests. Specifically:

• Accuracy Verification: Patient Tracker: "The Patient Tracker was evaluated for accuracy per ASTM F2554."
• Total System Accuracy: "The Total System was evaluated for accuracy via simulated use with a typodont as simulation of a patient with three osteotomies per typodont in four locations..."
• Guidance Arm Accuracy / Repeatability: "The positional accuracy of the Guidance Arm was evaluated by collecting 27 data points in spaces within two work volumes (54 total points) against a calibrated CMM."

These indicate individual component and system-level performance evaluations without direct human interaction as part of the performance metric itself, but rather evaluating the system's inherent accuracy.

7. Type of Ground Truth Used

• For accuracy verification in non-clinical testing: Calibrated CMM (Coordinate Measuring Machine) for Guidance Arm, and likely precise measurements from the typodont for total system accuracy, and ASTM F2554 standards for Patient Tracker.
• For clinical testing: Pre- and post-operative CT scans were used to measure the accuracy of the osteotomy relative to the pre-operative plan. The subjective criteria were based on the surgeons' evaluations (Likert scale surveys).

8. Sample Size for the Training Set

The document does not provide information regarding the sample size used for the training set. It largely focuses on the verification and validation of the device and its accuracy. As a surgical guidance system, its "training" often refers to the development and refinement of its algorithms and mechanical components rather than a machine learning training dataset.

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

As noted above, specific details about a "training set" and its ground truth establishment are not provided in this regulatory summary. The device's development likely involved engineering specifications, simulations, and iterative testing rather than a large-scale data-driven machine learning training approach with independently established ground truth labels in the conventional sense. The "Software and System Verification and Validation" section outlines various tests, but these are verification and validation steps, not training data generation.

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The IGI-System™, Image-Guided Implantation System, is a computerized navigational system intended to provide assistance in both the planning (preoperative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides accurate navigational guidance of surgical instruments, with regard to the pre-operative planning in dental implantation procedure.

The device is intended for use for partially edentulous and edentulous patients who require dental implants as part of their treatment plan.

System enabling image guided surgery for dental implant surgery through the utilization of planning software based on patient CT, registration through the use of fiducial markers and real time navigation by tracking both patient and handpiece movement and comparing to the pre-defined surgery plan.

This document, K052840, is a 510(k) summary for the IGI-System™ by Denx Ltd. It provides information about the device's classification, predicate devices, description, and indications for use. However, the provided text does not contain the specific details required to answer your questions about acceptance criteria and the study that proves the device meets those criteria.

Here's a breakdown of why I cannot answer your specific questions based on the provided text, and what kind of information would be needed:

The provided text focuses on:

• Administrative details: Applicant name, contact, date prepared, trade name.
• Regulatory classification: Device class, product code, predicate device.
• Device description: General overview of its function (image-guided surgery for dental implants).
• Indications for use: What the device is intended for (planning and surgical phases of dental implantation, for partially edentulous and edentulous patients).
• FDA correspondence: The letter from the FDA acknowledging the 510(k) submission and substantial equivalence.

Information NOT present in the provided text that is needed to answer your questions:

1. A table of acceptance criteria and the reported device performance: This would typically be found in a detailed performance study section, outlining specific metrics (e.g., accuracy, precision, success rates) and the target values for these metrics.
2. Sample sized used for the test set and the data provenance: Details on the number of cases/patients used, where the data came from (e.g., a specific dental clinic), and if it was collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth and their qualifications: Information about the panel of experts, their specialty (e.g., oral surgeons, prosthodontists), and years of experience.
4. Adjudication method for the test set: How disagreements among experts were resolved (e.g., majority vote, senior expert decision).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This describes a very specific type of study, usually for diagnostic or assistive AI devices, comparing human performance with and without the device. The IGI-System™ is described as a "computerized navigational system" for surgery, not primarily a diagnostic AI, making such a study less directly applicable or highly specific to its navigation accuracy.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This would be relevant if the device had an autonomous decision-making component, but as a navigation system, its performance is inherently human-in-the-loop.
7. The type of ground truth used: How the "true" outcome or measurement was determined (e.g., histology, CT measurements by an independent expert, follow-up outcomes).
8. The sample size for the training set: This refers to the data used to develop or "train" the underlying algorithms, which is distinct from the test set used for validation.
9. How the ground truth for the training set was established: Similar to the test set, but for the training data.

To provide the answers you're looking for, I would need to analyze a "Performance Data" or "Clinical Study" section of the 510(k) submission, which would detail the validation studies conducted to demonstrate the device's safety and effectiveness. This information is typically proprietary and not fully disclosed in the public 510(k) summary.

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