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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 NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). 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 precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument.

The implant process occurs in two phases. First, the dental 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. The NGS can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. The NGS provides haptic feedback to the surgeon by constraining the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.

The patient tracking portion of the NGS is comprised of linkages from the NGS, which include the Chairside Patient Splint (CPS) (K173402), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. 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 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, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is our Edentulous Patient Splint (EPS). The EPS is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (X-Guide Surgical Navigation System, K150222) rather than defining absolute acceptance criteria for novel performance claims. However, specific accuracy metrics are listed and compared.

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

• EPS Cadaver Testing:
  • Sample Size: 2 human cadaver heads.
  • Data Provenance: Not specified, but likely from a US-based facility where cadaver studies are conducted. This is a prospective test.
• IDE Study G190282 (Clinical Validation):
  • Sample Size: 10 adult patients (5 per site), resulting in 67 dental implants placed.
  • Data Provenance: Prospective, two-center study conducted in private practices (presumably in the US, as it's an FDA submission).

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

• EPS Cadaver Testing: One surgeon experienced with the NGS performed the procedures and answered qualitative performance questions. Qualifications: "Surgeon experienced with the NGS."
• IDE Study G190282 (Clinical Validation): Two clinical investigators (surgeons), one per site. Qualifications: "Fully licensed to practice dental implant surgery and were trained on use of the study device prior to starting the study."

4. Adjudication Method for the Test Set

• Cadaver Testing: Qualitative; likely based on the single surgeon's assessment. No formal adjudication method like 2+1 or 3+1 is mentioned.
• Clinical Validation (IDE Study): Implant location accuracy was examined using a "before and after analysis of CT data showing the location of the implant in the preop plan versus postop CT." It's not explicitly stated if independent experts or an adjudication panel reviewed these "before and after" CTs. The statement "All implants met system specifications for accuracy" suggests an evaluation against a predetermined quantitative threshold rather than a consensus-based adjudication process.

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

No MRMC comparative effectiveness study is mentioned in the provided text. The study focuses on the performance and usability of the device for dental implant surgery, with the device providing robotic guidance, rather than an AI assistance tool for human readers interpreting images.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

For the specific accuracy metrics (Lateral, Depth, Angular Accuracy), it's stated "The full system is used to perform a simulated clinical procedure on a typodont to measure the system accuracy," and also "The Patient Tracker was evaluated for accuracy per ASTM F2554," and "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." While these involve the system, the core device described is a robotic guidance system, not an AI algorithm that operates standalone. The accuracy values likely represent the standalone performance of the robotic system in guiding surgical instruments.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• System Accuracy (Lateral, Depth, Angular): Ground truth was established by precise measurements against a "calibrated CMM" (Coordinate Measuring Machine) for the guidance arm's positional accuracy and a "typodont" (dental model) for overall system accuracy. For clinical validation, post-operative CT data was compared to the pre-operative plan.
• Clinical Validation (IDE Study): The ground truth for effectiveness was direct comparison of post-operative implant location (via CT) against the pre-operative plan. Safety was assessed via follow-up for wound site healing. Usability was assessed via qualitative feedback from surgeons.

8. The Sample Size for the Training Set

The document does not specify a training set sample size for any machine learning or AI component. The Neocis Guidance System is described as a "computerized navigational system" providing "robotic guidance," and while it uses software and control systems, the text doesn't indicate a machine learning model that would typically have a "training set" in the context of image interpretation or diagnostic aid. The "planning software" is described as a tool for virtual implant placement.

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

As no training set for a machine learning component is described, this question is not applicable based on the provided text.

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