Search Results

Yomi Robotic System is a computerized robotic 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 robotic navigational guidance of the surgical instruments. The system can also be used for planning and performing guided bone reduction (also known as alveoplasty) of the mandible and/or maxilla. Yomi is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

When YomiPlan software is used for preplanning on third party PCs, it is intended to perform the planning (pre-operative) phase of dental implantation surgery. YomiPlan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of YomiPlan is to be used with the Yomi Robotic System.

Yomi Robotic System is a dental stereotaxic instrument and a powered surgical device for bone cutting. Yomi Robotic System 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 Yomi Robotic System is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Yomi Robotic System allows the user to plan the surgery virtually in YomiPlan, cleared for use alone on third-party PCs for preplanning. 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 for the system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The Yomi robotic arm holds and guides a standard FDA-cleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Clamped Chairside Patient Splint (C-CPS) or YomiLink Bone (YLB), the Tracker End Effector (TEE) 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 prior to the presurgical CBCT scan. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required).

The subject of this submission is to modify the design and reprocessing method for the Tracker End Effector (TEE) of the Yomi Robotic System. All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

Here's an analysis of the acceptance criteria and study information based on the provided text, using the requested structure:

1. Table of Acceptance Criteria & Reported Device Performance

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

The document does not explicitly state the sample sizes used for the performance tests (Total System Accuracy, Kinematic Repeatability, Drill Jig Accuracy, Disinfection Validation, Material Testing, Mating Component Design Verification). It only indicates that these tests were "fully executed."

For the Usability Validation Testing for reprocessing instructions, the document mentions "dental clinician users," but the specific number (sample size) is not provided. The data provenance is implied to be through direct observation and feedback from these users.

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

The document does not specify the number of experts or their qualifications for establishing ground truth for the performance tests. These tests appear to be engineering verification and validation tests rather than clinical studies requiring expert ground truth in the traditional sense.

For the Usability Validation Testing, it states that "dental clinician users" were involved, but their specific qualifications (e.g., years of experience, specialty) or the number of such users are not detailed.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method (e.g., 2+1, 3+1) for any of the described tests. The tests appear to be objective verification and validation tests where outcomes are measured against predefined technical specifications or industry standards.

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

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on performance testing related to design modifications and reprocessing.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The Yomi Robotic System is described as a "computerized robotic navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery." This implies a human-in-the-loop system. The document does not describe any standalone performance studies where the algorithm or robotic system operates without human interaction or oversight for clinical decision-making or execution. The "Total System Accuracy Verification" would likely assess the machine's standalone accuracy within the system's design, but not as a replacement for human performance.

7. Type of Ground Truth Used

For the performance tests (accuracy, repeatability, drill jig accuracy, material, design), the ground truth would be based on engineering specifications, metrology standards, and validated test methods. For the disinfection validation, the ground truth is established by microbiological testing against industry standards (AAMI TIR12 and FDA Guidance). For the usability testing, the ground truth is likely based on user feedback and successful completion of critical tasks as defined by the usability protocol. No explicit mention of clinical outcomes data or pathology as ground truth is made, which aligns with the focus on design modifications and reprocessing rather than a new clinical application.

8. Sample Size for the Training Set

The document does not describe any machine learning or AI components that would require a "training set" in the traditional sense. The device is a robotic system providing navigational guidance. If any internal models or algorithms are used, the training data for those are not disclosed in this summary.

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

Since no training set is mentioned (or implied for AI/ML purposes), this information is not provided.

Ask a specific question about this device

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 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. The NGS 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 patient tracking portion of the NGS is comprised of linkages from the NGS, which for partially edentulous patients include the Chairside Patient Splint (CPS) (K173402) or the Clamped Chairside Patient Splint (CCPS) (K202100), the End Effector (EE) and the Patient Tracker (PT). The CPS or CCPS 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 splint 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 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, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is a design change to the sleeves in our Edentulous Patient Splint (EPS) (K200805). The EPS enables use of the NGS in fully edentulous patients. It is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS and CCPS, 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 who qualify for dental implants.

The provided text discusses the Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS) and a design change to its sleeves. However, it does not contain a detailed study proving the device meets acceptance criteria for performance, especially not in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neocis Guidance System (NGS) with Patient Splints, K200805) after a design change to the EPS sleeves. The "Performance Testing" section lists various tests conducted, primarily related to the physical and biological aspects of the device, rather than a clinical performance study.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not available in the provided text for a clinical performance study.

Here's what can be extracted and inferred from the text, focusing on the design change and the tests mentioned:

Acceptance Criteria and Device Performance (Design Change Validation)

The document describes a design change to the sleeves within the Edentulous Patient Splint (EPS) component of the Neocis Guidance System (NGS). The acceptance criteria are implicitly related to ensuring this design change does not negatively impact the safety and effectiveness of the device, and that it remains substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated for performance tests like "EPS Weighted Deflection Test" or "Total System Accuracy". These are typically engineering verification tests, and the "sample size" would refer to the number of units tested.
• Data Provenance: Not specified for these engineering tests. "Sawbones®" is mentioned, indicating laboratory testing on synthetic bone models. This is not clinical data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable for the reported tests. The tests are engineering verification tests, not diagnostic accuracy studies requiring expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 study was mentioned or conducted. The device is a surgical guidance system, not a diagnostic AI tool for human readers.

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

• Not explicitly described as a standalone algorithm performance study. The "Total System Accuracy" test would assess the device's accuracy in guiding the surgical instrument, which is its primary function (albeit with a human surgeon operating the instrument under guidance). The text focuses on the mechanical and system accuracy of the guidance mechanism itself, not a diagnostic algorithm.

7. The type of ground truth used:

• For mechanical tests: Engineering specifications, precision measurements, or established physical benchmarks are the "ground truth."
• For biological tests: Standards (e.g., ISO 10993) and established laboratory protocols define the "ground truth" for material properties and effects.

8. The sample size for the training set:

• Not applicable. The document does not describe the development or training of an AI algorithm in the context of a "training set" for diagnostic performance.

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

• Not applicable. See point 8.

Summary of Device Performance (from the document's conclusion):
The primary conclusion is that "The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate." This implies that all the listed performance tests were successfully passed, ensuring that the modified device remains as safe and effective as its predecessor.

Ask a specific question about this device

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.

Ask a specific question about this device

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 quidance 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 decision- making process during the surgical procedure. It is not intended to replace the surgeon's judqment. 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 K182776 (the predicate device), except for a change to the dental drill supplier and dental drill collar design. The dental handpiece and motor have received previous 510(k) clearance under K070084 and K030163.

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 dental materials specified in the labeling. 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 provided text describes information about the Neocis Guidance System (NGS), a computerized navigational system for dental implantation surgery. However, the document (a 510(k) premarket notification) primarily focuses on demonstrating substantial equivalence to a predicate device due to a change in dental drill supplier and collar design, rather than proving the device meets new acceptance criteria established for this specific submission.

Therefore, the information regarding acceptance criteria and study details is largely drawn from previous clearances (K173402 and K161399) as the current submission leverages prior performance testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" presented as a single, consolidated list with corresponding performance for the current submission (K191605). Instead, it refers to the performance characteristics of the device, which serve as criteria for substantial equivalence to the predicate. The "Prior Performance Testing" sections (K173402 and K161399) detail various verification and validation activities.

For this submission, the comparison table (Table 1) between the subject device and the predicate device outlines several technical characteristics. The implicit acceptance criterion for these is "no difference" compared to the predicate, as highlighted in the "Comments" column.

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 provides limited specific numbers for test set sample sizes and provenance:

• Total System Accuracy (K173402): Evaluated with "a typodont as simulation of a patient with three osteotomies per typodont in four locations (Upper Right / Upper Left / Lower Right / Lower Left)." This implies multiple osteotomies on each typodont, but the exact number of typodonts is not specified.
• Guidance Arm Accuracy / Repeatability (K161399): "collecting 27 data points in spaces within two work volumes (54 total points) against a calibrated CMM."
• Other tests: Descriptions like "Run through of Typical Use Case," "Testing of all potential boundary parameters," and "Simulating all error messages and pop-ups" do not provide specific numerical sample sizes.
• Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, beyond indicating "simulated use" on typodonts/in a simulated clinical environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Simulated Use (End User Validation) (K173402 and K161399): Performed by "Surgeons" (K173402) and "End User" (K161399). The number of surgeons/end users and their specific qualifications (e.g., years of experience, specialization) are not specified in the provided text.

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

The document does not describe any adjudication method used for establishing ground truth in the reported tests.

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

The document refers to the Neocis Guidance System as a "computerized navigational system" and a "stereotaxic medical device that guides surgeons." It is a surgical guidance device, not an AI-powered diagnostic or interpretive tool that assists "human readers." Therefore, an MRMC comparative effectiveness study involving human readers (as typically seen in diagnostic imaging AI) is not applicable to this type of device, and no such study is mentioned. The system assists surgeons during the surgical procedure rather than enhancing their interpretation of images.

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

The device is designed for human-in-the-loop operation, as it "guides surgeons" and "is not intended to replace the surgeon's judgment." The reported accuracy tests (System Lateral Accuracy, System Depth Accuracy, System Angular Accuracy, Guidance Arm Accuracy / Repeatability) likely represent the standalone technical performance of the guidance system's robotic/mechanical components, separate from the surgeon's manual actions, but within the context of a simulated surgical environment where the system provides guidance. The document does not explicitly present "standalone algorithm performance" in a way that separates algorithmic output from its interaction with the mechanical guidance system.

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

The ground truth for the reported accuracy tests appears to be physical measurements against established benchmarks or calibrated equipment.

• Total System Accuracy (K173402): Accuracy was evaluated, implying a comparison against a known, intended plan or precise measurements on the typodont.
• Guidance Arm Accuracy / Repeatability (K161399): Evaluated "against a calibrated CMM" (Coordinate Measuring Machine), which provides highly accurate physical measurements.
• End User Calibration Verification (K161399): "Dimensional analysis and verification of Calibration Materials."

8. The sample size for the training set

The document does not provide any information regarding a training set or its sample size. This type of surgical guidance system typically relies on computational geometry, kinematics, and control theory rather than machine learning models that require labeled training data in the same way as an AI diagnostic algorithm.

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

Since no training set is mentioned for an AI/machine learning model, this question is not applicable. The device's functionality is based on established engineering principles and calibration processes.

Ask a specific question about this device

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.

Ask a specific question about this device