(28 days)
The TruDi® Navigation system is intended for use during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model.
The TruDi® Navigation System V3 is intended to be used during surgical procedures in ENT and ENT skull base surgery to support navigation of instruments to the targeted anatomy, where reference to a rigid anatomical structure can be identified relative to a CT or MR based model. The TruDi® Navigation System V3 enables ENT physicians to access sphenoid, frontal, and maxillary sinuses, as well as the skull base, by using the systems magnetic tracking technology, which is the same technology used by the predicate device. The system incorporates a Navigation Console, Emitter Pad, Instrument Hub, Patient Tracker, Registration Probe, Workstation and peripherals. A magnetic field generated by the Emitter Pad induces a current in the magnetic sensor embedded in the tip of the navigated tool, which helps to accurately calculate the tool tip position. A CT or MR image is imported and registered to the patient coordinates and the navigated tool tip icon is displayed on top of the registered image, indicating the position of the tool tip in reference to the patient anatomy. A Patient Tracker is fixed to the patient forehead to compensate for the head movement during the surgical procedure.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Subject Device V3) |
|---|---|
| Accuracy specification: 2mm RMS | Bench Location Accuracy: 0.55mm (STD 0.2) |
| Simulated Use Location Accuracy: 1.2mm (STD 0.2mm) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of human data or patient cases. The performance data is derived from non-clinical bench testing and simulated use.
- Bench Location Accuracy: This test compared the TruDi® Navigation System's electromagnetic locations to those provided by a highly accurate robot system over its entire navigation volume. While a sample size of "locations" would have been involved in this measurement, the specific number is not provided.
- Simulated Use Location Accuracy: This involved performing a complete CT image registration and instrument navigation workflow. The specific sample size for "simulated uses" is not provided.
The data provenance is not from human patients; it's from laboratory (bench) and simulated environments. Therefore, country of origin is not applicable in the typical sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not applicable as the 'test set' for accuracy was based on objective measurements (robot system, simulated workflow) and not on expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth was established through objective measurement tools and processes (robot system, simulated workflow) rather than human adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary to determine that the subject TruDi® Navigation System V3 performs as intended." This indicates that the evaluation was purely technical and non-clinical.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone (algorithm only without human-in-the-loop performance) evaluation of the device's core accuracy functions was done. The "Location Accuracy tests... where the TruDi® Navigation System electromagnetic locations were compared to the locations provided by a highly accurate robot system" directly assesses the system's inherent accuracy in a controlled, non-human environment. The "Simulated use accuracy test" also falls under this, evaluating the system's accuracy within a simulated workflow.
7. The Type of Ground Truth Used
The ground truth used for accuracy assessments was based on:
- Highly accurate robot system measurements for Location Accuracy tests.
- Known/defined parameters within a simulated use workflow for Simulated Use Location Accuracy tests.
8. The Sample Size for the Training Set
The document does not provide any information regarding a training set size. This device is a navigation system primarily relying on electromagnetic tracking technology, not a machine learning model that typically requires a separate training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or its ground truth establishment within the provided document.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).