(26 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 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:
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance/Conclusion |
|---|---|---|
| Mechanical Performance (Splint) | EPS Weighted Deflection Test with Optical Tracking in Sawbones® | Implied to have met predefined limits for deflection, ensuring stability and accuracy. The document states "The new design is functionally the same as the predicate device." |
| System Accuracy | Total System Accuracy | Implied to have met accuracy requirements (likely related to navigational guidance precision), ensuring the design change does not degrade the overall system's ability to guide surgical instruments accurately. |
| Risk Management | ANSI AAMI ISO 14971:2019 Medical devices Applications of risk management to medical devices | Risk analysis performed and controls implemented to mitigate risks associated with the design change. Concludes no new questions of safety or effectiveness. |
| Sterilization | ANSI AAMI ISO 17665-1:2006/(R)2013 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical device | Sterilization process validated for the new material/design. |
| Biocompatibility | ANSI AAMI ISO 10993-1:2009/(R)2013 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process | Biological evaluation indicating the new materials (Neocis design titanium for sleeves, removal of stainless steel from patient-contacting materials) are safe for patient contact. |
| ANSI AAMI ISO 10993-5:2009/(R)2014 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | No cytotoxicity detected. | |
| ANSI AAMI ISO 10993-10:2010/(R)2014 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | No irritation or skin sensitization detected. | |
| ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity | No systemic toxicity detected. | |
| ANSI AAMI ISO 10993-12: 2012 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials | Sample preparation and reference materials used were appropriate for the biocompatibility testing. | |
| Conclusion of Substantial Equivalence (Overall System) | Overall, 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. | The subject device is substantially equivalent to the predicate, meaning it is as safe and effective as the previously cleared device. |
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.
§ 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.