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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 guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The implant process occurs in two phases: planning and surgical. Physical guidance is provided via the Guidance Arm. Visual guidance is provided by 3D graphics and 2D cross sections. The patient tracking portion is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth and has a fiducial array. The Patient Tracker is a mechanical feedback system connected to the Patient Splint. Calibration and measurement steps are required using the Calibration Drill Bit and Depth Gauge. The NGS is a supporting device and does not replace the surgeon's judgment. The subject device is the same as the predicate device (K173402) except for a change to the dental materials used to affix the splint.

This document describes the Neocis Guidance System (NGS) and its equivalence to a previously cleared predicate device (K173402), specifically focusing on the modification of dental materials used to affix the chairside patient splint.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for system accuracy (lateral, depth, and angular) and the reported performance for the Neocis Guidance System (NGS) are provided below. These criteria and performance values were established for the predicate device (K173402) and are stated to be unchanged for the subject device.

Study Proving Device Meets Acceptance Criteria:

The current submission (K182776) focuses on demonstrating substantial equivalence for the modified dental materials used to affix the chairside patient splint. It relies on performance testing previously performed on the predicate NGS (K161399 and K173402) for the overall system accuracy and other technical characteristics. The document explicitly states: "The subject of this 510(k) was only a modification to the dental materials used to affix the chairside patient splint. As such, non-clinical testing performed in support of clearance of the predicate NGS itself did not need to be repeated."

Therefore, the studies verifying the system accuracy parameters listed above were conducted on the predicate device (K161399 and K173402). The specific details of these studies are summarized below from the provided text for both the predicate device and the new material validation:

• For the Predicate Device's Overall System Accuracy (K173402 and K161399):

  • 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 (Upper Right / Upper Left / Lower Right / Lower Left)."
  • Patient Tracker Accuracy: "The Patient Tracker was evaluated for accuracy per ASTM F2554."
  • 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."

• For the Substantial Equivalence of New Dental Materials (K182776):

  • Material polymerization temperature measurements: Splints were affixed to typodonts using the new dental materials in a heat box at 37°C. Curing temperature was measured with a thermocouple, and maximum temperatures were reported.
  • Rigidly mounted splint deflection measurement: Splints were mounted to typodonts using the new dental materials, and a load 2-times the weight of the Patient tracker was applied. Deflection was measured at various points using a FARO arm. Mean deflection with standard deviation was reported.
  • Comparison of materials' material safety data sheets (MSDS): MSDS sheets were compared to assess material compositions and safety hazards.
  • Simulated clinical use validation: Surgeons affixed and removed chairside patient splints from typodonts using the new dental materials. Qualitative validation and usability endpoints were recorded.

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

Due to the nature of this 510(k) submission which focuses on a material change and relies heavily on previous clearances for system performance, specific sample sizes for all test sets are not exhaustively detailed for this current submission.

• Predicate Device (K173402/K161399) Studies (for overall system accuracy):
  • Total System Accuracy: 1 typodont (with 3 osteotomies per typodont in 4 locations). The data provenance is implied to be from laboratory testing/simulated use, likely in the US (where Neocis Inc. is located).
  • Patient Tracker Accuracy: "evaluated for accuracy per ASTM F2554" - specific sample size not provided, but implies standard testing methods. Data provenance is implied to be laboratory testing.
  • Guidance Arm Accuracy / Repeatability: 27 data points in spaces within two work volumes (total 54 points). Data provenance is implied to be laboratory testing.
• Current Submission (K182776) Studies (for new dental materials):
  • No specific sample sizes (e.g., number of typodonts, number of splints tested) are provided for the material polymerization, deflection measurement, or the simulated clinical use validation. The format "Splints were affixed to typodonts..." suggests multiple instances, but the exact number isn't quantified. The data provenance is implied to be from laboratory testing/simulated use, likely in the US.

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

• For the Predicate Device's Overall System Accuracy (K173402/K161399):
  • Simulated Use (End User Validation): "Run through of typical splint affixation cases using typodonts, performed by Surgeons." The number of surgeons is not specified. Their qualifications are listed generally as "Surgeons" (implying dental surgeons relevant to the device's indications for use), but specific experience years are not provided.
  • End User Validation of User Requirements: "Validation of User Requirements as they pertain to NGS Design and Development, and Software Lifecycle Design and Development, performed by End User in simulated environment." "End Users" would typically be dental surgeons, but their specific number and qualifications are not detailed.
• For the Current Submission (K182776) Studies (for new dental materials):
  • Simulated clinical use validation: "Surgeons affixed and removed chairside patient splints from typodonts using the dental materials specified in this submission." The number of surgeons is not specified, nor are their specific qualifications beyond "Surgeons."

4. Adjudication Method for the Test Set

The provided text does not explicitly describe an adjudication method (like 2+1, 3+1). The tests appear to be primarily quantitative measurements (accuracy, deflection, temperature) or qualitative assessments of usability ("qualitative validation and usability endpoints were recorded" for simulated clinical use), where consensus or adjudication processes are not typically applied in the same way as, for example, expert review of images.

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

No MRMC comparative effectiveness study is mentioned, nor is an effect size for human readers improving with AI vs. without AI assistance. This device is a robotic guidance system, not an AI-assisted diagnostic imaging tool that would typically involve human reader studies. It guides the surgeon during the procedure rather than providing diagnostic information.

6. Standalone Performance Study

Yes, standalone performance (i.e., algorithm only without human-in-the-loop performance) was done for various components and overall system accuracy, as implied by the non-clinical testing performed on the predicate device. Examples include:

• Total System Accuracy: "The Total System was evaluated for accuracy via simulated use with a typodont..."
• Patient Tracker Accuracy: "The Patient Tracker was evaluated for accuracy per ASTM F2554."
• Guidance Arm Accuracy / Repeatability: Positional accuracy evaluated against a calibrated CMM.
• Measurements of "material polymerization temperature" and "rigidly mounted splint deflection" for the new materials are also forms of standalone, objective measurements.

7. Type of Ground Truth Used

The ground truth used primarily consists of objective physical measurements from calibrated instruments and established standards.

• For system accuracy, it would be the precisely known positions and angles within a calibrated test setup (e.g., against a CMM for Guidance Arm accuracy, or the planned osteotomy sites in a typodont for total system accuracy).
• For the new materials, ground truth involved direct measurements of temperature and deflection using instruments like thermocouples and FARO arms.
• For usability, the "ground truth" is a qualitative assessment by surgeons during simulated use.

8. Sample Size for the Training Set

No information regarding a "training set" or "training data" is provided. This device is a robotic guidance system, not a machine learning or AI algorithm that typically would have a distinct training phase requiring a training set in the conventional sense. The "software and system verification and validation" (Table 3) describes comprehensive testing of software functions and system boundaries, but these are verification/validation activities, not "training."

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

As no training set is mentioned for the device's functionality, this question is not applicable based on the provided document. The device's operation is based on pre-programmed guidance and real-time tracking, not on a learned model derived from a training dataset.

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