(86 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 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:
- Bite force testing on fiducial markers
- Cut removal
- Loaded splint deflection testing using 2x PT weight
- Simulated clinical use: end user validation on a typodont
- Fiducial marker registration
- Fiducial marker single use autoclave test
- 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).
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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.
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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.
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Adjudication method for the test set: Not explicitly stated.
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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.
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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.
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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.
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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.
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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.
§ 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.