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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.

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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

In terms of FDA regulations, the Neocis Guidance System (NGS) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). 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.

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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

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

The implant process occurs in two phases. First, the dental surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. The NGS provides haptic feedback to the surgeon by constraining the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.

The patient tracking portion of the NGS is comprised of linkages from the NGS, which include the Chairside Patient Splint (CPS) (K173402), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

For the specific accuracy metrics (Lateral, Depth, Angular Accuracy), it's stated "The full system is used to perform a simulated clinical procedure on a typodont to measure the system accuracy," and also "The Patient Tracker was evaluated for accuracy per ASTM F2554," and "The positional accuracy of the Guidance Arm was evaluated by collecting 27 data points in spaces within two work volumes (54 total points) against a calibrated CMM." While these involve the system, the core device described is a robotic guidance system, not an AI algorithm that operates standalone. The accuracy values likely represent the standalone performance of the robotic system in guiding surgical instruments.

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

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

8. The Sample Size for the Training Set

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

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

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

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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) (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 accurate navigational guidance of surgical instruments, with regard to pre-operative 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 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 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 device is a design variation of the predicate CPS (K173402). The portion of the splint that attaches to the patient now contains the fiducial markers. We are calling the subject device, the Fiducial Array Splint (FAS). This provides an alternative workflow in which the FA is not needed. These are the only changes in this submission. The NGS is otherwise the same as the cleared device (K161399). The indications for use and contraindications for the subject and predicate devices are the same.

Since the fiducial markers are on the portion of the splint that is affixed using dental material, we do have to limit the use of cleared dental materials (K182776) to those that are not radioopaque:

• 3M ESPE ProTemp Plus
• Alike
• Traid C&B Material (UV light curable)

The other dental materials cleared for use with the CPS cannot be used with the FAS.

Since the FAS does need the FA, we can use the FAS in CBCT scanners with smaller scan volumes and standard chin rests.

The Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) is a computerized navigational system for dental implantation surgery. This 510(k) submission (K200348) describes a design variation to the patient tracking portion of the NGS, specifically the Fiducial Array Splint (FAS). The primary change is the integration of fiducial markers directly into the splint, eliminating the need for a separate Fiducial Array (FA).

Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of acceptance criteria with corresponding reported device performance metrics in numerical terms. Instead, it states that "Our performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate device." The "SE Analysis" column in Table 1 generally indicates "Identical," "Additional radio-transparent dental materials from reference device K182776," "Fiducial beads relocated to the FAS," and "Simpler interface, less parts." These are characteristic-level comparisons rather than quantitative performance metrics against specific acceptance criteria.

The document indicates that additional Neocis Performance Testing was conducted, including:

1. Bite force testing on fiducial markers
2. Cut removal
3. Loaded splint deflection testing using 2x PT weight
4. Simulated clinical use: end user validation on a typodont
5. Fiducial marker registration
6. Fiducial marker single use autoclave test
7. Total system accuracy testing

While these tests were performed to demonstrate substantial equivalence, the specific quantitative acceptance criteria for each test and the corresponding performance results are not detailed in this document. The conclusion states that performance testing "demonstrates substantially equivalent performance," implying that any defined acceptance criteria for these tests were met.

Study Details

The provided document describes a validation study for the newly designed Fiducial Array Splint (FAS) in comparison to the predicate Chairside Patient Splint (CPS) (K173402).

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

   • Test Set Sample Size: Not explicitly stated in terms of number of patients or experimental runs for each performance test. The document mentions "Simulated clinical use: end user validation on a typodont," which indicates a phantom-based testing approach.
   • Data Provenance: The study was conducted by Neocis Inc. The document does not specify the country of origin for the data or whether the study was retrospective or prospective, but given it's an end user validation on a typodont, it's a prospective, in-house validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. The "Simulated clinical use: end user validation on a typodont" implies that dental professionals would be involved in using the device and evaluating its performance, but the number and qualifications of these "end users" are not detailed.

3. Adjudication method for the test set: Not explicitly stated.

4. 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: Not applicable. This device is a Guidance System for surgical procedures, not an AI-assisted diagnostic or interpretive tool where "human readers" or "cases" in the MRMC sense would typically apply. The focus is on the accuracy and safety of surgical instrument guidance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The "Total system accuracy testing" and other performance tests likely involved assessing the device's accuracy and functionality in a simulated environment, which could be considered standalone testing of the underlying guidance system's physical and software components. However, the "Simulated clinical use: end user validation" implies human-in-the-loop testing as well.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For performance tests on a typodont model, the ground truth would typically be established by precise measurements of the planned versus actual implant trajectory/osteotomy, using high-precision measurement tools (e.g., CMM, optical tracking systems) to determine deviations from the pre-planned positions. This is a form of engineering measurement against a defined plan rather than expert consensus on a diagnosis or pathology.

7. The sample size for the training set: Not applicable. This document describes the validation of a physical medical device and its associated software for surgical guidance, not a machine learning algorithm that requires a "training set" for model development.

8. How the ground truth for the training set was established: Not applicable, as there is no mention of an AI model requiring a training set in this context.

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.

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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments.

The Neocis Guidance System (NGS) is a stereotaxic medical device that guides surgeons during dental implant surgery. The system allows the user to plan the surgery virtually in software using a CT scan of the patient, and the plan is used by a quidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation.

The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan.

Physical guidance is provided via the Guidance Arm. The Guidance Arm grips a standard dental drill from the back end, allowing the surgeon to grip the drill as normal. The Guidance Arm does not move unless the surgeon applies a manual force to the drill. The Guidance Arm will constrain the surgeon to drill according to the prescribed surgical plan, preventing deviation. The surgeon is constantly in control of the drilling.

Visual guidance is provided by 3D graphics and 2D cross sections that indicate the position and orientation of the drill in relation to the pre-operative plan and scan. The visual feedback is updated in real-time so any relative motion between the dental handpiece and the patient properly update the visualization.

The patient tracking portion of the NGS is comprised of the Patient Splint and the Patient Tracker. The Patient Splint is attached to the contralateral side of the patient's mouth. The Patient Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Patient Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

Several steps are required for calibration and measurement during the procedure. The drill is calibrated using the Calibration Drill Bit inserted into a precise position on the Patient Tracker. During the surgery, each drill bit must be measured with the Depth Gauge to determine the proper length of the bit. These measurements complete the loop so the entire NGS is accurate to the tip of the drill.

The NGS is a supporting device, providing additional information and quidance to the decisionmaking process during the surgical procedure. It is not intended to replace the surgeon's iudgment. The final clinical decisions are the sole responsibility of the surgeon. The surgeon can at any time during the surgical procedure modify the planned implant positions. Under no circumstances does the device relieve the surgeon of his or her ultimate clinical responsibility.

The subject device is the same as the NGS cleared under K161399 (the predicate device), except for a change to the splint. The Patient Splint of the predicate device has been modified to allow for a chairside workflow. This modified splint is referred to as the Chairside Splint.

The splint is a key component for patient tracking for the NGS. The patient tracking portion of the NGS is comprised of the Chairside Splint and the Patient Tracker. The Chairside Splint is attached to the contralateral side of the patient's mouth. The Chairside Splint is affixed to the patient's teeth using Lang Jet Tooth Shade Dental Acrylic (K083195). The Chairside Splint is placed on the patient prior to the CT scan. A fiducial array with fiducial markers is placed on the Chairside Splint prior to the CT scan so the virtual plan can be related to the physical space of the system. The Patient Tracker is a mechanical feedback system that is connected to the Patient Chairside on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle and position to accommodate the patient movement, which will maintain the accuracy of the drill placement.

The Neocis Guidance System (NGS) with Chairside Splint is a computerized navigational system intended to assist in planning and performing dental implantation surgery. The device provides software for pre-operative planning and navigational guidance for surgical instruments.

The acceptance criteria for the NGS, and the reported device performance, are as follows:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Clinical Test Set

• Sample Size: 75 subjects.
• Data Provenance: The document does not explicitly state the country of origin but implies a clinical study at two different sites. The study was prospective in nature, as it involved the application and removal of the Chairside Splint on subjects by investigators for evaluation.

3. Number of Experts and Qualifications for Clinical Test Set Ground Truth

• Number of Experts: 15 dentists.
• Qualifications of Experts: The document states "a variety of experience levels" for the investigator population. Specific years of experience or specializations (e.g., radiologist) are not provided.

4. Adjudication Method for Clinical Test Set

The document does not explicitly describe an adjudication method for the clinical test set data. It mentions "objective criteria and subjective criteria" for evaluation but not a process for resolving discrepancies if multiple assessors were involved in evaluating a single case/subject.

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

No mention of an MRMC comparative effectiveness study was made. The clinical study focused on human factors related to the Chairside Splint rather than comparing the effectiveness of human readers with and without AI assistance or quantifying an effect size of AI improvement.

6. Standalone (Algorithm Only) Performance Study

The document indicates that the NGS is a "computerized navigational system" and a "supporting device, providing additional information and guidance to the decision-making process during the surgical procedure. It is not intended to replace the surgeon's judgment." This strongly suggests that the device is designed for human-in-the-loop performance, and there is no mention of a standalone algorithm-only performance study. Accuracy metrics (System Lateral, Depth, and Angular Accuracy) are defined for the "System," implying the integrated device rather than an isolated algorithm.

7. Type of Ground Truth Used (Clinical Test Set)

The clinical study primarily focused on human factors related to the Chairside Splint application and removal. The "ground truth" for this aspect appears to be:

• Objective Criteria: Duration of application and removal, photos and intra-oral scans, occurrence of adverse events.
• Subjective Evaluation: Investigator assessments.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. The studies described are verification and validation efforts for the modified device (Chairside Splint) and the overall NGS system, rather than the development and training of a machine learning algorithm in the typical sense that would involve a distinct training set. The NGS, as described, is a navigational guidance system, not explicitly an AI diagnostic or predictive tool that undergoes a training phase with a labeled dataset.

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

As no training set is described, the method for establishing its ground truth is not applicable or provided. The system's "accuracy" (lateral, depth, angular) is based on engineering verification and validation testing against known physical standards and simulated clinical scenarios.

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