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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

• ANSI AAMI ISO 14971: 2019 (Risk Management)
• ANSI AAMI IEC 62304:2006/A1:2016 (Software Life Cycle Processes)
• FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
• FDA Guidance for Cybersecurity in Medical Devices (Oct 2, 2014; Dec 28, 2016)
• Cybersecurity for Networked Medical Devices (Jan 14, 2005)
• AAMI TIR57: 2016 (Medical Device Security) |
  | Wireless Coexistence | Safe and effective operation with continuous Wi-Fi in the presence of other radio-frequency devices. | Tested according to:
• AAMI TIR69: 2017 (Risk management of radio-frequency wireless coexistence for medical devices and systems)
• IEEE ANSI C63.27-2017 (American National Standard for Evaluation of Wireless Coexistence) |
  | Electromagnetic Compatibility (EMC) | Compliance with EMC standards for medical electrical equipment. | Tested according to:
• IEC 60601-1-2 Edition 4.1 2020-09 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests) |
  | Clinical Performance (Primary Function) | Not explicitly detailed in this 510(k) summary for the subject device. This submission is for a modification to a previously cleared device, assuming its fundamental clinical performance is already established. | "Our performance testing demonstrates substantially equivalent performance of the subject device as compared to the predicate." (This statement refers to equivalence, not necessarily a new clinical performance study for the modified device). |

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. 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.

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