(287 days)
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
| Category / Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Software Verification | Compliance with relevant software and risk management standards. | Fully executed according to: |
- 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.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.