(267 days)
NaviENT is a computerized surgical navigation system intended to guide sinus and trans-nasal skull base endoscopic surgery by dynamically presenting the location of the tip of a surgical instrument mapped to a corresponding location in a pre-acquired CT scan of the patient's head. The device is intended for use by a qualified ENT surgeon (otolaryngologist).
NaviENT is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the skull, can be identified relative to images of the anatomy. Surgery procedures include but are not limited to the following: transphenoidal procedures, maxillary antrostomnies, ethmoidectomies, sphenoidectomies, sphenoid explorations, turbinate resections, frontal sinusotomnies, intranasal procedures, intranasal tumor resections, and ENT related skull base surgery.
NaviENT is a cart-based, computerized, image-guided navigational system, operating as a combined package for performing guided ENT surgery.
Using pre-acquired CT scan of the sinus, NaviENT provides the surgeon (usually otolaryngologists) with easy-to-use real-time guidance during sinus surgery. The key function performed by NaviENT during navigation is visualization of the instrument tip relative to the surrounding anatomy. This visualization assists the surgeon in performing the surgery.
NaviENT consists of four main components:
- NaviENT Cart
- Tracking System
- Laptop Computer
- NaviENT Instruments
Here's a breakdown of the acceptance criteria and study information for the NaviENT device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy: The text states, “All system requirements, including accuracy requirements, were validated thoroughly, and found to be comparable to those specified by the FDA cleared predicate devices.” For the predicate device (NPU system, K964229), the text mentions a claimed accuracy of 2.56mm. | The NaviENT system demonstrates performance in 3D positional accuracy with average error of less than 2mm. This performance was determined using 3 different human head models in an OR simulated environment with all of the typical navigation instruments. |
| Software Validation: Software requirements met and performs as intended. | Successful testing verifying the software requirements are met and software performs as intended. |
| Cleaning and Sterilization: Components can withstand recommended cleaning, disinfection, and sterilization processes, achieving a Sterility Assurance Level (SAL) of 10^-6. | Re-usable NaviENT components were tested and validated that they can withstand the recommended cleaning, disinfection, and sterilization processes, achieving an SAL of 10^-6. Sterilization validation was conducted according to ISO 17665-1:2006. |
| Bench Testing: All planned performance tests meet their acceptance criteria. | All planned performance tests were executed as planned, and all of them succeeded in meeting their acceptance criteria. |
| Electrical and EMC Testing: Adherence to IEC 60601-1:2005 (electrical safety), IEC 60601-1-2:2007 (electromagnetic compatibility), and IEC 62471:2006 (photobiological safety of lights). | The NaviENT system was tested for electrical safety and essential performance according to the requirements IEC 60601-1:2005. It passed all relevant requirements of IEC 60601-1-2:2007 and IEC 62471:2006. |
| Biocompatibility Testing: Patient-contacting components are biocompatible. | The patient-contacting NaviENT components were tested according to the requirements of ISO 10993-1 and were deemed to be biocompatible. |
| Human Factors: Demonstrate substantial equivalence with regards to differences in system user interface and use scenarios from the predicate. | Human factors report and validation testing provided sufficient data to support their conclusion of substantial equivalence with regards to differences in system user interface and use scenarios from the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: For accuracy testing, 3 different human head models were used.
- Data Provenance: The testing was conducted in an OR simulated environment. The country of origin of the data is not explicitly stated, but the submission is from ClaroNav Inc. in Toronto, Canada. Given the context of a 510(k) submission, this would be considered a prospective performance study designed for regulatory approval.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not explicitly provided in the document. The accuracy testing was done using "human head models," which typically implies a phantom-based or simulated setup for objective measurement rather than expert-derived ground truth on clinical data.
4. Adjudication Method for the Test Set:
This information is not explicitly provided in the document. For benchtop accuracy testing using physical models, an adjudication method like 2+1 or 3+1 by human experts is typically not necessary. The ground truth would be based on precise physical measurements of the models.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
An MRMC comparative effectiveness study is not mentioned in the document. The study described is a device performance and accuracy study, not one designed to evaluate the clinical effectiveness of human readers using the device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
The study described is a standalone performance study of the NaviENT system's accuracy and various other aspects (software, sterility, electrical safety, biocompatibility, human factors). It evaluates the device's inherent performance characteristics rather than how it performs with a human in a clinical setting. The device itself is described as a "computerized surgical navigation system," implying an algorithmic core.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
For the accuracy testing, the ground truth was established by physical measurements on human head models within an OR simulated environment. This is a form of engineered or phantom-based ground truth, where the true positions are precisely known or measurable. For other tests (sterilization, biocompatibility, electrical safety), the ground truth is against established ISO and IEC standards and their specific test methodologies.
8. The Sample Size for the Training Set:
This information is not provided in the document. The document describes a medical device with an image guidance component, but it does not detail any machine learning or AI models that would require a separate "training set" in the conventional sense. The "NaviENT software" processes data, but it's not indicated as a learning-based system with a distinct training phase in this submission.
9. How the Ground Truth for the Training Set Was Established:
As no training set is mentioned (see point 8), this information is not applicable/provided.
§ 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).