(111 days)
Navident is a computerized dental navigational system intended to assist preoperative planning and to guide drilling in a patient jaw during implantation surgery, using pre-acquired CT scan of the jaw. The device is intended for use by a qualified dental surgeon in the treatment of partial edentulism.
Navident is a cart-based, computerized, image-guided dental navigational system, operating as a combined package for performing both pre-operative planning and guided implant insertion. Using preacquired CT scan of the jaw, Navident provides the dentist (usually a GP dentist, prosthodontist, periodontist or dental surgeon) with implantation planning and real-time guidance during dental implants insertion.
The guidance function of Navident is primarily provided using a visualization of the drill pose (tip location and shaft axis direction) relative to the desired pose of the implant, as planned on a preacquired CT image of the jaw. This visualization assists the dentist in implementing their implantation plan.
Navident consists of four main components:
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- A notebook computer positioned above the patient's chest. The Navident software running on the computer provides both planning and navigation functionalities.
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- A handpiece attachment. The attachment consists of a universal removable metal adapter, and a specially marked plastic part, named DrillTag, which latches on the adapter.
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- A customizable patient jaw attachment consisting of a moldable stent part, named NaviStent, and a matching specially marked plastic tag, named JawTag. NaviStent can be formed, customized and tested for fit directly on the patient's jaw or on a plaster model. The patient wears the NaviStent during the CT scan and again during the surgery. Navident is able to continuously register NaviStent's position during surgery with its appearance in the CT scan automatically.
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- An optical position sensor which detects high contrast patterns printed on the DrillTag and JawTag and constantly reports their relative positions to the Navident software.
Here's a breakdown of the acceptance criteria and study details for the Navident device, based on the provided text:
Navident Device Performance and Acceptance Criteria
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy at the drill tip | ≤ 1.0 mm |
| Presentation update rate | Real time |
| System immunity to electromagnetic interference (acc. IEC 60601-1-2) | System passed all tests while providing accurate drilling guidance |
| Sterilization of reusable components (acc. ISO 17665-1:2006) | Validated to reach acceptable sterility assurance level |
| Biocompatibility (acc. ISO 10993-1, 10993-5, 10993-10) | Met all acceptance criteria for cytotoxicity, hypersensitivity, and irritation |
Study Details Proving Acceptance Criteria
Due to the nature of the provided document (a 510(k) summary), specific details for some categories (like distinct training vs. test sets or formal MRMC studies) are not fully separated as might be found in a later clinical trial report. However, the summary describes various performance and clinical evaluations.
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Table of Acceptance Criteria and Reported Device Performance: (See table above)
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Sample Size Used for the Test Set and Data Provenance:
- Bench Testing: Performed with various settings and conditions (e.g., different image voxel sizes, distances, lighting, random jaw models). The exact number of "tests" or "samples" for each specific parameter is not quantified.
- Human Factors/Usability Summative Evaluation: 15 representative users (oral surgeons, general dental practitioners).
- Clinical Case Data: 21 cases with 36 guided implantations. The geographical provenance (country of origin) is not explicitly stated but implies international, as it mentions "a diverse international group of surgeons." This appears to be retrospective collected over time as "feedback on usage history."
- Clinical Evaluation (Systematic Feedback): 7 surgeons who treated a total of 150 patients. The provenance is again "diverse international group of surgeons" and appears to be retrospective collection of "usage history and professional impressions."
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- For the human factors/usability evaluation, 15 "representative users (i.e., oral surgeons, general dental practitioners)" were observed. Their role was more as "test subjects" or "users" rather than establishing a separate "ground truth" in terms of clinical outcomes, though their feedback contributed to the "usability problems" assessment.
- For the clinical case data and systematic feedback, the ground truth regarding "accuracy averaging 1.0mm deviation from plan at both entry and apex" was likely established through post-procedure analysis by the "experienced user" (qualified dental surgeon) themselves or by the study investigators. The qualifications of these 7 surgeons and the "diverse international group of surgeons" are defined as "qualified dental surgeon." No specific number of independent experts for ground truth adjudication is given for the accuracy assessment, rather it describes "an experienced user is able to achieve."
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Adjudication Method for the Test Set:
- No formal multi-reader adjudication method (e.g., 2+1, 3+1) is described for the clinical accuracy assessment. The summary states, "Accuracy assessment demonstrated that, with Navident's guidance, an experienced user is able to achieve an implant placement accuracy averaging 1.0mm deviation from plan at both entry and apex." This implies a measurement against the pre-planned position, which serves as the "ground truth" for deviation.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No MRMC comparative effectiveness study, specifically comparing human readers with AI vs. without AI assistance, is mentioned. The device is a "computerized dental navigational system" providing real-time guidance, not an AI diagnostic aid that assists human readers in interpreting images. Its direct comparison is against a predicate surgical navigation system.
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If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the "Full system bench testing" (point 3 under SUMMARY OF PERFORMANCE TESTING) evaluates the "Overall accuracy of the system in mapping the drill tip to the CT image" and other operational aspects without direct human surgical intervention as the primary performance metric. This represents the standalone performance of the navigation system's mapping and guidance precision.
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The Type of Ground Truth Used:
- Bench Testing: Engineering measurements against known physical standards or simulated conditions.
- Clinical Cases (Accuracy): Deviation from the "planned pose of the implant" as visualized on the pre-acquired CT image. The pre-planned position serves as the ground truth for measuring positional / angular deviation.
- Clinical Cases (Outcomes): "No significant patient adverse events or complications were reported." This relies on outcomes data from the surgeons.
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The Sample Size for the Training Set:
- The document describes a "510(k) summary," which focuses on demonstrating substantial equivalence and performance testing rather than algorithm development. It does not provide details on a specific "training set" for an AI algorithm. The device is a mechanical/software navigation system, not primarily an AI deep learning model that requires a large training dataset in the conventional sense. The "training" here refers to its design and calibration processes.
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How the Ground Truth for the Training Set was Established:
- Not applicable in the context of an AI training set. The "ground truth" for the system's design and calibration would have been engineering specifications and physical measurements, ensuring its tracking capabilities (Stereoscopic triangulation of illuminated checker-board patterns) and mapping accuracy.
§ 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.