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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.

In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). The 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 NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants. The system allows the user to plan the surgery virtually in Yomi Plan. The operative plan is based on a cone beam computed tomography (CBCT) scan of the patient, which is used to create a 3-D model of the patient anatomy in our planning software. The plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The NGS robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument. The patient tracking portion of the NGS is comprised of linkages from the patient to the NGS, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), the End Effector (EE) and the Patient Tracker (PT). A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the NGS in order to track patient movement. The subject of this submission is adding Intraoral Fiducial Array (IOFA) as a new device accessory based on a previously cleared design. The IOFA is intended for use in clinical sites with reduced scan volumes. The IOFA is designed to reside with all the fiducial beads within the patient's mouth. The IOFA can only be used with the C-CPS.

Here's a summary of the acceptance criteria and study information for the Neocis Guidance System (NGS) with Intraoral Fiducial Array (IOFA), based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Notes on Acceptance Criteria: The document primarily uses "Same as the subject device" or similar phrasing for the predicate/reference devices, indicating that these performance metrics are consistent across the devices and establish the acceptance criteria for the new IOFA.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The document does not explicitly state the sample size for the test set for all verification activities. However, it mentions an "IOFA End User Validation" which is described as a "nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a Intraoral Fiducial Array directly to a patient." The specifics of this "validation" and its sample size are not detailed.

The data provenance (country of origin, retrospective/prospective) is not mentioned in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

For the "IOFA End User Validation," it states the validation was "as performed by a surgeon (end user)." The specific number of surgeons or their qualifications are not specified. For other performance tests like accuracy, the ground truth is likely established through a combination of manufacturing specifications, calibrated measurement tools, and engineering standards, rather than expert consensus on a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not describe any adjudication method for establishing ground truth from multiple experts. Given that most performance metrics are objective measurements (e.g., RMS accuracy), formal adjudication methods typically used for subjective clinical assessments are unlikely to be applied.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or performed. The device is a "computerized navigational system" providing guidance, not an AI for image interpretation or diagnosis that would typically involve a multi-reader study. The text explicitly states, "Animal or clinical testing was not conducted for the subject device."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device (NGS with IOFA) is described as a "computerized navigational system intended to provide assistance" and "provides navigational guidance of the surgical instruments." It also emphasizes that the "surgeon may modify the plan intraoperatively...and is always in control of the surgical instrument." This indicates a human-in-the-loop system. Therefore, a standalone (algorithm only) performance assessment as would be done for an AI diagnostic algorithm is not applicable in the same way. The performance metrics focus on the accuracy of the system's guidance (lateral, depth, angular accuracy), which are inherently tied to the interaction with the human user and surgical instruments.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the verification tests (Registration Testing, Kinematic Mount Repeatability, Scan Artifact Testing, Fit Clearance Simulation, Total System Accuracy, IOFA Deflection Test) appears to be based on:

• Engineering measurements and calibrated standards: For system accuracy (lateral, depth, angular), sensor ranges, and physical properties.
• Established industry standards: For electrical safety, electromagnetic disturbances, ingress protection, biocompatibility (ISO standards), and sterilization (ISO standards).
• Design specifications: For CT scan quality requirements, guidance arm speed, and storage requirements.

For the "IOFA End User Validation," the ground truth is implied to be a qualitative assessment of rigidity and usability by a surgeon, simulating real-world application.

8. The sample size for the training set:

The document does not mention a training set size. The device is a "computerized navigational system" and its software (Yomi Plan v2.0) was cleared previously. This type of device relies on engineering design, calibration, and deterministic algorithms for guidance, rather than a machine learning model that requires a "training set" in the conventional AI sense.

9. How the ground truth for the training set was established:

As no training set is described for an AI/machine learning model, the process for establishing ground truth for a training set is not applicable or mentioned. The system's functionality is verified against established engineering and safety standards.

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