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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).

In terms of previously FDA-cleared indications for use, the Neocis Guidance System (NGS) (K161399) 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 system allows the user to plan the surgery virtually in our Neocis Planning Software Application installed on the NGS planning station or on a 3rd party PC (K191363). 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 powered bone cutting instrument (K191605).

The patient tracking portion of the NGS is comprised of linkages from the patient to 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 NGS 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 implant process occurs in two phases: (1) The dental surgeon plans the surgical procedure with the planning software, on the day of surgery or sometime prior if a pre-operative CT scan was taken at an earlier visit. A virtual dental implant, selected from the dental implant library or using a generic model, both contained within our planning software, is placed at the desired location in the patient model. The software highlights critical anatomical structures to avoid, such as the inferior alveolar nerve. (2) When the dental implant plan is optimized, the NGS provides precise and accurate guidance of the dental surgical instruments according to the preoperative plan. The NGS robotic arm, which holds the surgical instrument, provides haptic feedback to the surgeon by constraining the motion of 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 surgeon may modify the plan intraoperatively, if needed, has direct visualization of the patient anatomy, and is always in control of the surgical instrument.

Key safety features include:

• Emergency stop
• Safety pause
• Audio and visual queues
• Drill torque limits
• Surgeon control

The subject device in this submission is the new Clamped Chairside Patient Splint (C-CPS). The C-CPS offers our users an alternative to acrylic-type dental material affixation. The subject device replaces the acrylic-type dental material locking mechanism of affixation with a clamplike mechanism of affixation using softer dental impression (registration) material, alignment slots, and an approximation screw. The clamping screw is not a bone screw, and it does not interact directly with the patient. The screw is positioned above the teeth inside the splint. The subject device is essentially a CPS (K173402) that has been bisected lengthwise with screw holes and alignment slots in each half to approximate the two halves around the patient's stable teeth. The dental impression material is placed inside the splint to form a tight conformational gripping surface between the splint and the teeth. The dental impression material conforms the shape of the patient's teeth to form a large gripping surface area. The C-CPS initial placement is like a dental impression tray. A torque-brake screwdriver with hex bit is used to tighten and loosen the screw. The proper C-CPS model (left/right or anterior/posterior) should be selected based upon the accommodation of the patient's anatomy and the intended surgical location.

The provided text describes a 510(k) premarket notification for the Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS). The submission aims to demonstrate substantial equivalence to a predicate device, the NGS with Chairside Splint (K173402), by introducing a new clamping mechanism for the patient splint.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to the predicate device and lists several identical technological characteristics, including system accuracy specifications.

Explanation of the Acceptance Criteria for the C-CPS:

The main purpose of this submission is the introduction of the Clamped Chairside Patient Splint (C-CPS) as an alternative to the existing Chairside Patient Splint (CPS) (K173402). Therefore, the "acceptance criteria" are not new performance metrics for the overall guidance system, but rather demonstrate that the new C-CPS component does not negatively impact the established performance of the NGS system and meets safety and functional requirements.

The document lists several verification activities to confirm the C-CPS's performance in relation to these system accuracy and functional requirements. These are implicitly the acceptance criteria for the C-CPS module itself:

• Clamped Chairside Patient Splint (C-CPS) Splint Deflection Test with Optical Tracking: (Implicit acceptance: deflection within acceptable limits to maintain system accuracy).
• Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Teeth): (Implicit acceptance: pressure within safe and effective limits).
• Clamped Chairside Patient Splint (C-CPS) Kinematic Mount Repeatability: (Implicit acceptance: provides consistent and repeatable connection for tracking, contributing to overall system accuracy).
• Clamped Chairside Patient Splint (C-CPS) Pressure Assessment (Soft Tissue): (Implicit acceptance: pressure within safe and effective limits).
• Clamped Chairside Patient Splint (C-CPS) Removal Force Test: (Implicit acceptance: allows for safe and effective removal).
• Clamped Chairside Patient Splint (C-CPS) DOE for Parameter Evaluation: (Implicit acceptance: relevant parameters are optimally defined).
• Clamped Chairside Patient Splint (C-CPS) Screw Failure Test: (Implicit acceptance: screw designed to withstand expected forces without failure).
• Clamped Chairside Patient Splint (C-CPS) Lingual-Buccal Assembly Failure Torque: (Implicit acceptance: assembly maintains integrity under expected torque).
• Dimension Analysis (Clamped Chairside Patient Splint (C-CPS) vs. Chairside Patient Splint (CPS)): (Implicit acceptance: dimensional compatibility and understanding of differences).
• Total System Accuracy: (Implicit acceptance: overall system accuracy, including the C-CPS, remains within the established RMS < 1 mm for lateral/depth and RMS < 6.0° for angular accuracy).

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

The document mentions "Verification" and "Validation" activities, but does not explicitly state the sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

The "C-CPS Technique Validation: Simulated Clinical Testing" is described as a "nonclinical surrogate that simulates the process of applying, qualitatively evaluating rigidity, and removing a C-CPS directly to a patient." This indicates the testing was likely conducted in a controlled lab environment rather than on actual patients.

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

The document states, "C-CPS Technique Validation: Simulated Clinical Testing... To validate the user requirements of the C-CPS, as performed by a surgeon (end-user)." This implies that at least one "surgeon (end-user)" was involved in the qualitative evaluation. However, the exact number of experts, their qualifications, and how "ground truth" was established are not specified. Given it's a simulated clinical test, the "ground truth" would likely be based on the qualitative assessment of the surgeon(s) performing the task.

4. Adjudication Method for the Test Set:

No adjudication method is described for the verification or validation tests. The qualitative evaluation by a "surgeon (end-user)" suggests a subjective assessment rather than a formal adjudication process using multiple reviewers.

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 was performed or described. The device is a robotically assisted surgical system, not an AI diagnostic tool that assists human readers/interpreters in a diagnostic task. The "AI" component is likely in the planning software and robotic guidance, not in image interpretation.

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

No standalone algorithm-only performance study is explicitly described. The device is a "computerized navigational system" that provides "navigational guidance of the surgical instruments," which implies a human-in-the-loop system. The surgeon is always "in control of the surgical instrument" and receives haptic feedback. The "Total System Accuracy" test would represent the performance of the system with all its components, including the robotic guidance based on the algorithm, but this is not a standalone algorithm without a physical output or human interaction.

7. The Type of Ground Truth Used:

For the performance characteristics like "System Lateral/Depth/Angular Accuracy," the ground truth would typically be established by highly precise measurement tools (e.g., optical tracking systems, CMMs) in a controlled laboratory setting, comparing the planned trajectory to the actual trajectory.

For the "C-CPS Technique Validation: Simulated Clinical Testing," the ground truth for "user requirements" and "rigidity" would be qualitative assessment by a surgeon (end-user), likely against predefined criteria for ease of application, stability, and removal.

8. The Sample Size for the Training Set:

Not applicable/Not provided. This submission describes a modification to a physical component (patient splint) of an existing robotic guidance system, not an AI model that requires a training set in the conventional sense (e.g., for image classification or prediction). The core "planning software" is mentioned as Neocis Planning Software Application v1.2 (K161399) or v1.8.1 (K191363), but no details on training data for these software versions are provided in this document.

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

Not applicable/Not provided. As explained above, this submission doesn't detail the training of an AI model.

In summary:

This 510(k) submission focuses on demonstrating substantial equivalence for a hardware modification (the C-CPS) to an existing dental navigation system. The "acceptance criteria" are predominantly implicit in proving that the new component does not degrade the established performance specifications of the overall system and meets new functional and safety requirements related to its design and use. The studies performed are primarily verification and validation tests in a simulated environment to confirm these aspects, rather than clinical trials or AI-specific performance evaluations involving large datasets or multiple human readers.

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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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