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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 robotional 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 Robotic System is intended for use in partially 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 the 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 Patient Splint (YomiLink Teeth or YomiLink Bone), Tracker End Effector (TEE), and the Patient Tracker (PT). In cases where YomiLink Teeth is utilized, it is attached to the contralateral side of the patient's mouth over stable teeth using on-label dental materials prior to the presurgical CBCT scan. In cases where YomiLink Bone is utilized, it is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required), or after the scan when using the subject YomiLink Arch device.

The subject of this submission is to introduce new accessories, the YomiLink Arch and Probing Bit. The YomiLink Arch allows for CBCT scan acquisition prior to YomiLink Bone placement and enables guided YomiLink Bone placement. This submission also introduces an update to the system planning software to enable use of the YomiLink Arch (YLA).

Following attachment of YomiLink Bone (YLB) to the patient, probing of the YLA is performed utilizing the YLA Probing Bit to transfer registration in the software from YLA to YLB and allow for tracking of the YLB throughout the remaining surgical procedure. The YLA Probing Bit is available in straight and contra-angle configurations corresponding to the handpiece to which they are attached.

All other aspects of the Yomi Robotic System remain unchanged from prior clearances.

This document describes the regulatory approval of the Neocis Yomi Robotic System with new accessories (YomiLink Arch and Probing Bit), indicating substantial equivalence to a previously cleared device. However, it does not provide explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for an AI device. Instead, it refers to performance testing conducted to ensure the device functions as intended.

Based on the provided text, here's an attempt to structure the information, acknowledging the limitations for a full AI acceptance criteria description:

1. Table of Acceptance Criteria and Reported Device Performance

As the document is a 510(k) summary for a robotic surgical system, not a purely AI diagnostic or prognostic device, the "acceptance criteria" are described in terms of verification and validation testing to ensure the added accessories and workflow maintain the system's intended function and safety. Specific numerical performance metrics for AI algorithms (like sensitivity or specificity) are not provided in this regulatory summary.

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

The document does not specify the sample size for individual tests, nor does it provide details on the data provenance (e.g., country of origin, retrospective/prospective). The performance testing described appears to be a series of engineering and usability validations rather than a clinical study with a patient-derived test set in the conventional sense of AI performance evaluation. The "test sets" would likely refer to engineering models, simulated environments, and potentially cadaveric or phantom models for accuracy and repeatability testing.

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

This information is not provided in the document. For a robotic system, "ground truth" often involves highly precise measurement equipment and established engineering benchmarks rather than expert clinical consensus for image interpretation. For human factors validation, usability experts and clinicians would be involved, but specific numbers and qualifications are not listed here.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No MRMC study is mentioned. This type of study is typically performed for AI systems that assist human readers in diagnostic or screening tasks. The Yomi Robotic System is a surgical guidance system, and the "AI" component is more embedded in its navigation and planning software, not as a separate diagnostic reader.

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

The performance testing revolves around the integrated system, including the software and new accessories (YomiLink Arch and Probing Bit) as they interact within the existing Yomi Robotic System workflow. While core algorithm accuracy is verified, it's presented within the context of the overall system's function, not as a standalone AI diagnostic output. The YomiPlan software is for preplanning, and its output is to be used with the Yomi Robotic System, not as a standalone diagnostic.

7. The Type of Ground Truth Used

The ground truth for the device's accuracy and performance would be established through a combination of methods typical for robotic systems:

• Physical measurements: Using highly accurate metrology equipment to verify positioning, deflection, and repeatability against known physical standards.
• Engineering specifications: Comparing system performance against pre-defined engineering tolerances and design requirements.
• Simulation/Phantoms: Testing the system's ability to accurately navigate and execute plans on controlled phantom models.
• User requirements: For human factors and software end-user validation, the "ground truth" would be the successful completion of tasks by users in accordance with specified requirements and industry standards for usability.

Specific details about the type of ground truth for each test are not elaborated in this summary.

8. The Sample Size for the Training Set

The document does not mention the sample size for the training set. For a robotic navigational system like Yomi, "training" might refer to the development and refinement of algorithms for spatial recognition, registration, and robotic control. This process typically involves extensive internal validation and iterative development with various datasets (e.g., 3D models, CBCT scans) but does not necessarily align with the concept of a "training set" in the context of supervised machine learning for diagnostic tasks.

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

This information is not provided. Similar to point 7, the "ground truth" for developing such a system would be based on engineering principles, known anatomical landmarks, and precise spatial measurements to ensure accurate digital representations and their correlation with physical reality for robotic guidance.

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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

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 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

In terms of FDA regulations, the Yomi Robotic System is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). In terms of previously FDAcleared indications for use (K210711), the 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 System allows the user to plan the surgery virtually in Yomi Plan, 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 FDAcleared third party powered bone cutting instrument.

The patient tracking portion of Yomi is comprised of linkages from the patient to Yomi, which include the Chairside Patient Splint (CPS) or Edentulous Patient Splint (EPS), 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 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 introducing a feature to allow the system to be used for planning and performing guided bone reduction (also known as alveoplasty). The bone reduction feature is intended for use during dental implant procedures to flatten the surface of the bone intended for dental implant placement. The device is used with compatible bone cutting tool secured to the guidance arm for the bone reduction. The bone reduction feature is intended to be performed on full arch or partially edentulous patients. During preoperative planning, the surgeon identifies the area of the bone to be reduced. Real-time visualization of the bone reduction is visualized on the graphic user interface. The guidance arm constrains the movement of the cutting tool to the planned location, boundaries, and depth. After the bone reduction, the implant procedure continues with the Yomi Robotic System.

Here's an analysis of the provided text to extract information about the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that the device is "substantially equivalent" to predicate devices, but it does not explicitly list specific acceptance criteria with numerical targets or thresholds. Instead, it focuses on demonstrating equivalence through various performance tests and comparisons.

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

• Test Set Description: The document refers to "Full system cadaver validation" for both the primary predicate and the subject device (section V and Table 1). It also mentions "Human Factors Validation for Bone Reduction" and "Software End User Validation of Bone Reduction."
• Sample Size: The exact sample size (number of cadavers, number of users for human factors/software validation) is not specified in the provided text.
• Data Provenance: The cadaver validation implies use of human anatomical specimens, and "Human Factors Validation" suggests involving human users. The origin (e.g., country) of these cadavers or participants is not specified. The studies appear to be prospective in nature, as they involve testing the new feature.

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

This information is not provided in the text. The document mentions "surgeon plans" in the workflow description, implying clinical expertise, but it does not detail the involvement of experts in establishing ground truth for testing or validation purposes.

4. Adjudication Method for the Test Set:

This information is not provided in the text. There is no mention of a formal adjudication process (e.g., 2+1, 3+1 consensus) for establishing ground truth or evaluating test results.

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

An MRMC comparative effectiveness study was not explicitly mentioned in the provided text. There is no information about human readers improving with or without AI assistance. The focus is on the robotic system's performance and substantial equivalence.

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

The document describes the Yomi Robotic System as a "computerized robotic navigational system intended to provide assistance in both the planning... and the surgical (intra-operative) phases." It explicitly states that the system "provides robotic navigational guidance of the surgical instruments" and "provides physical, visual, and audible feedback to the surgeon." This strongly indicates that the device is designed for human-in-the-loop operation, and therefore, a standalone (algorithm only) performance study would likely not be the primary focus or relevant to its intended use. The performance testing focuses on the system's accuracy and functionality within this assisted context.

7. Type of Ground Truth Used:

The document mentions "Bone reduction accuracy verification" and "Full system cadaver validation." This suggests that the ground truth for performance was established based on:

• Physical measurements/direct observation on anatomical specimens (cadavers): For verifying the accuracy of bone reduction performed by the robot.
• Planned surgical boundaries: The system guides based on a pre-operative plan, so the ground truth would be the accurately executed plan.

8. Sample Size for the Training Set:

The document does not provide any information regarding a training set or its sample size. This is typical for 510(k) submissions focusing on substantial equivalence for robotic-assisted surgical devices, which often rely on established engineering principles, verification, and validation rather than large-scale machine learning model training.

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

As no training set is mentioned, this information is not applicable/provided in the text.

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Yomi 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. Yomi is intended for use in partially 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. Yomi Plan provides pre-operative planning for dental implantation procedures using the Yomi Robotic System. The output of Yomi Plan is to be used with the Yomi Robotic System.

The subject of this submission is YomiPlan Go, a feature of the Yomi Robotic System which enables the use of the system without the uploading of a preoperative CT scan. The dynamic planning feature in K202264 requires a pre-operative CT scan for use. This submission includes a new workflow called YomiPlan Go and provides instructions on how to use this feature without the need of uploading a CT scan to the Yomi system. This planning involves placing the robotic arm drill tip to the point where an osteotomy is to be performed i.e., the surgeon performs planning with their direct visualization of the anatomy and with the use of the robotic arm to select where the osteotomy is to be performed. YomiPlan Go gives surgeons the ability to perform an osteotomy under robotic guidance at the point that the surgeon selects on the patient's anatomy. The selected point, axis, and trajectory are maintained by the robotic arm while the surgeon performs the osteotomy.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 44 implants placed in 15 patient arches.
• Data Provenance: Prospective, multi-center, single-arm study (G210363) involving partially or fully edentulous patients. The study was conducted clinically with actual patients. The specific country of origin is not explicitly stated, but the submission is to the US FDA, implying it would be relevant to US practice.

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

• Number of Experts:
  • 3 investigators (general dentists) who performed the procedures.
  • 1 independent 3rd party oral surgeon who performed an independent clinical assessment of all 15 cases.
• Qualifications of Experts:
  • Investigators: General dentists.
  • Independent Assessor: 3rd party oral surgeon. Specific years of experience are not mentioned for any of the experts.

4. Adjudication Method for the Test Set:

• The text describes case-by-case feedback from investigators (through CRF feedback) and an independent 3rd party clinical review of all 15 cases. This suggests a form of independent review rather than a strict 2+1 or 3+1 consensus process among multiple readers for ground truth establishment. Agreement between these groups (investigators' safety feedback, 3rd party review), especially regarding "no vital anatomical structure concerns," served as a form of "ground truth" for clinical safety and acceptability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

• No, an MRMC comparative effectiveness study was not explicitly stated to have been done in the traditional sense of evaluating human readers with and without AI assistance.
• The study primarily focused on the standalone performance of "YomiPlan Go" relative to freehand techniques and comparison metrics with the predicate device. The "human factors" evaluation was for the new YomiPlan Go workflow itself by the operating surgeons, not a comparison of human interpretation/performance with and without AI.
• The benefits assessment does highlight how YomiPlan Go assists surgeons (e.g., depth stop, prevention of skiving, parallelism, precision in repeated drilling), which could be interpreted as improving human performance, but this wasn't quantified through an MRMC study design measuring specific effect sizes of human improvement.

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

• Yes, in part, a standalone assessment of the algorithmic component's performance (precision, depth, and lateral error) was conducted as a secondary objective of the clinical study, comparing pre-operative plans (ideal locations) to post-operative implant placement.
• The system's precision specification (Upper 95% Probability with 95% Model Fit < 1.00 mm) is also mentioned as supported by benchtop verification testing, which would typically be a standalone performance test. However, the accuracy is explicitly stated as "N/A for YomiPlan Go" as it's not a specification for this specific mode, which relies on the surgeon's real-time visual assessment rather than a pre-loaded CT.

7. The Type of Ground Truth Used:

• The ground truth for the performance metrics (depth, lateral, and angular error) was established by comparing preoperative clinical plans (ideal planned implant locations on CBCT scans) with postoperative CBCT scans capturing the actual placement of implants.
• For clinical safety and acceptability, the ground truth was based on the assessment and feedback from the investigators and an independent 3rd party oral surgeon, specifically their confirmation of "no vital anatomical structure concerns."

8. The Sample Size for the Training Set:

• The document does not provide information on the sample size for the training set for the Yomi or YomiPlan Go system. The focus of this submission is on the clinical validation of a new feature (YomiPlan Go) for a previously cleared device.

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

• The document does not provide information on how the ground truth for the training set was established. Since the details of the training set size or methodology are not given, the ground truth establishment method for it is also absent.

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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 adult patients who qualify for dental implants.

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

The purpose of subject device is for modification of the Neocis Guidance System (K202264) to allow for Wi-Fi to be continuously active in the Yomi Plan v2.0.1 while it is powered on. All other software and hardware features/functions remain identical to the predicate. 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 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.

Major components include: Monitor, Planning Station Laptop PC, Lift Column, Base Cart, Robotic Guide Arm, and Patient Tracker.

The system allows the user to plan the surgery virtually in Yomi Plan (K191363-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 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 FDAcleared third party 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) or Edentulous Patient Splint (EPS) (K200805), the End Effector (EE) and the Patient Tracker (PT).

The request is to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the Neocis Guidance System (NGS) with Yomi Plan v2.0.1.

Based on the provided text, the submission does not contain a study proving that the device meets specific performance acceptance criteria for its clinical function. Instead, it modifies an existing, previously cleared device (NGS with Yomi Plan v2.0) to allow continuous Wi-Fi activity and describes the testing conducted to ensure this modification maintains safety and effectiveness, primarily through software verification, wireless coexistence testing, and EMC testing.

Therefore, the following information is extracted and presented in relation to the modification and associated testing, rather than a clinical performance study with acceptance criteria for the device's primary function of dental implantation guidance.

Acceptance Criteria and Study Proving Device Meets Criteria

The Neocis Guidance System (NGS) with Yomi Plan v2.0.1 is a modification of a previously cleared device (Neocis Guidance System (NGS) with Yomi Plan v2.0, K202264). The primary change in this submission is to allow Wi-Fi to be continuously active in the Yomi Plan v2.0.1 while it is powered on. Therefore, the "acceptance criteria" and "study" described below relate to the safety and effectiveness of this change and the overall system's compliance with relevant standards.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for test sets related to clinical performance. The testing described relates to technical compliance (software, wireless, EMC).

• Data Provenance: Not applicable in the context of clinical data for this specific 510(k) submission, as it doesn't describe a clinical study for performance. The testing pertains to engineering and regulatory standards for the device modification.

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

• Not applicable. This submission focuses on engineering testing (software, wireless, EMC) rather than a clinical study requiring expert-established ground truth for device performance validation in a patient setting.

4. Adjudication Method for the Test Set

• Not applicable. This submission focuses on engineering testing, not a study requiring adjudication of clinical outcomes or interpretations.

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, an MRMC comparative effectiveness study was not done as described in the provided text. The device is a computerized navigational system for dental implantation, not an AI-assisted diagnostic or interpretation tool for human readers. This submission focuses on a software modification (continuous Wi-Fi) and its impact on technical safety and performance.

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

• Not explicitly detailed. The described testing pertains to the integrated system's technical compliance and software behavior (Yomi Plan v2.0.1) in the context of continuous Wi-Fi. While individual software components would undergo standalone verification, the submission does not describe a standalone clinical performance study. The device is described as providing "navigational guidance of the surgical instruments" and "haptic feedback to the surgeon by constraining the motion of the bone cutting instrument to the plan," implying human-in-the-loop operation.

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

• Not applicable. For the technical testing (software verification, wireless coexistence, EMC), the "ground truth" is adherence to established engineering standards, cybersecurity protocols, and functional specifications, rather than clinical ground truth (e.g., pathology, expert consensus on images).

8. The Sample Size for the Training Set

• Not applicable. The submission does not describe a machine learning or AI model that requires a training set. The software is a planning and guidance system not explicitly described as employing AI in a way that requires a training set for model development.

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

• Not applicable. As no training set is described for an AI/ML model.

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). 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.

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

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

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 (K200805), 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 system allows the user to plan the surgery virtually in Yomi Plan (K191363-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 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 (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) or Edentulous Patient Splint (EPS) (K200805), 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. The EPS is placed using bone screws prior to the presurgical CBCT scan (appropriate local anesthesia is required). 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
• Full surgeon control and direct visualization of the surgical field

The Neocis Guidance System (NGS) with Yomi Plan v2.0 is a "catch-up" focused on the planning software and presenting changes made from v1.2 (K161399) to the current release v2.0 (wireless network capabilities, interface updates, etc.). The Neocis Guidance System (NGS) contains two software packages: (1) planning and (2) control. Each resides on a separate PC on the device: (1) planning station laptop PC and (2) control PC in the cart base. There are no changes to the control software or the NGS hardware in this submission. The use of TeamViewer has been implemented to access NGS systems that connected to external networks to examine system performance for postmarket.

The provided text describes a 510(k) premarket notification for the "Neocis Guidance System (NGS) with Yomi Plan v2.0". This submission primarily focuses on updates to the planning software (Yomi Plan v2.0) and the addition of wireless network capabilities. It does not include detailed acceptance criteria or a study proving device performance against those criteria in the way a clinical trial or algorithm validation study typically would. Instead, it relies on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics, software verification and validation, and wireless coexistence testing.

Therefore, many of the requested details cannot be extracted from the provided document as they are not present.

Here's what can be inferred or stated based on the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly list "acceptance criteria" and "reported device performance" in a table format for a specific clinical or performance outcome. Instead, it focuses on demonstrating that the updated software (Yomi Plan v2.0) and new wireless features do not negatively impact the system's intended use and maintain substantial equivalence to predicate devices.

The "Performance Testing" section (Page 8) mentions that "Software V&V has been fully executed" and "Wireless Coexistence was testing according to the following". This implies that the acceptance criteria for these aspects would be compliance with the listed standards and successful execution of the validation activities.

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

• Test Set Sample Size: Not explicitly stated for performance testing (e.g., how many cases or patients were used in end-user validation).
• Data Provenance: Not specified. The end-user validation was performed in a "simulated use environment." This suggests it was not a real-world patient study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

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

• Not specified.

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. The device provides "navigational guidance" but is not primarily an AI-driven diagnostic or interpretative tool evaluated by human readers in this context. The focus is on the safety and effectiveness of the updated planning software and wireless functionality.

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

• The document implies that the "planning software" (Yomi Plan) is part of a "computerized navigational system" that provides "navigational guidance of the surgical instruments" to a surgeon. The system provides "haptic feedback to the surgeon" and emphasizes "Full surgeon control and direct visualization of the surgical field." This indicates a human-in-the-loop system. Standalone algorithm performance without human interaction is not the primary focus or explicitly described for the system's core function. The "planning" component could be considered "standalone" in its ability to create a plan, but its output is used by the guidance system in a human-controlled surgical procedure.

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

• For the software V&V, the "ground truth" would be adherence to software requirements, standards, and risk management principles. For wireless coexistence, it would be compliance with communication standards. For "End User Validation," it's ensuring the system "meet[s] the needs of the user," which implies functional correctness and usability in a simulated surgical context. Specific clinical ground truth based on patient outcomes or expert pathological review is not detailed in this submission as it's not a diagnostic AI device.

8. The sample size for the training set:

• The document describes a software update for a guidance system and does not mention machine learning or AI training sets. Therefore, this information is not applicable and not provided.

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

• Not applicable, as no training set for machine learning/AI is mentioned.

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 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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