(28 days)
The Navitrack™ System - FluoroSpine is a stereotaxic instrument indicated for use in precisely positioning instruments or implants during orthopaedic surgery, such as operations performed within spinal structures.
The Navitrack™ System enables the surgeon to review radiology images from different modalities in 2D and 3D display. This system also enables the surgeon to virtually manipulate bone structures as reconstructed from these modalities in order to perform preoperative planning.
The Navitrack "10 System - FluoroSpine device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories. It is designed to assist the surgeon in the placement of spine reconstruction components relative to the vertebrae. Tracking devices are incorporated with given surgical instruments, as well as on to bases that attach to the vertebrae, such to allow the ability to track and display to the user their respective positions intra-operatively. The vertebrae are displayed to the user as based on a fluoroscopic image obtained at the beginning of the procedure. Given instrument and implant components that need to be positioned are schematically represented superimposed on the vertebrae image to depict their relative locations.
The provided text describes the Navitrack™ System - FluoroSpine, a stereotaxic instrument for orthopedic surgery, and its 510(k) submission (K031156). However, the document does not explicitly state specific acceptance criteria or report detailed performance metrics with numerical values in a table format.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Navitrack System™ - Optical Option). The performance data section vaguely states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate as compared to the predicate." This indicates that the performance criteria were implicitly tied to matching or not degrading from the predicate's performance.
Given the information provided, here's an attempt to outline the requested details, with significant parts indicating where information is not available in the given text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied/Referenced) | Reported Device Performance (Implied) |
|---|---|
| Accuracy of system adequate (compared to predicate) | The system's accuracy was found to be "adequate as compared to the predicate." The specific numerical accuracy values or metrics (e.g., in millimeters, degrees) or the defined threshold for "adequate" are not detailed in this document. |
| Performance of system adequate (compared to predicate) | The system's performance was found to be "adequate as compared to the predicate." The specific performance metrics (e.g., speed, reliability, precision) or the defined threshold for "adequate" are not detailed in this document. |
| No new safety and efficacy issues raised | Non-clinical tests were performed to "assess that no new safety and efficacy issues were raised." No specific issues were identified. |
| Substantial equivalence to predicate | The device was found to be substantially equivalent to the Navitrack System™ - Optical Option predicate, implying it meets similar safety and efficacy profiles. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided document. The text only mentions "Non-clinical tests were performed." It does not detail specific cases, images, or scenarios used in testing.
- Data Provenance: Not specified. There is no mention of country of origin, or whether the data was retrospective or prospective. Given the non-clinical nature mentioned, it's likely referring to bench testing or simulations rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
The document focuses on "non-clinical tests" and comparison to a predicate, not on a study involving expert-established ground truth for a test set of clinical images.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified/Not applicable. As no expert review or ground truth establishment based on clinical data is detailed, an adjudication method is not described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned in the provided document. The evaluation focused on the device's functional equivalence to a predicate.
- Effect Size of Human Readers with AI vs. without AI Assistance: Not applicable as no MRMC study was reported.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Standalone Study: The document describes "non-clinical tests" to verify "accuracy and performance of the system." While not explicitly called a "standalone study," the nature of these tests, comparing the system's output to that of the predicate, suggests an evaluation of the algorithm/system's inherent performance rather than human-in-the-loop performance. However, the exact methodology and metrics are not detailed.
7. The Type of Ground Truth Used
- Type of Ground Truth: The document implies that the ground truth for "accuracy and performance" verification was likely established by the performance of the predicate device (Navitrack System™ - Optical Option) or by known engineering specifications/measurements for the new system's components and overall function during non-clinical testing. It is not based on expert consensus, pathology, or outcomes data as would be typical for image analysis AI.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable/Not specified. The Navitrack™ System - FluoroSpine is described as a software-driven workstation that assists surgeons by superimposing schematic representations on fluoroscopic images. It is not an AI/ML algorithm that learns from a training set in the typical sense (e.g., for image classification or segmentation). Its functionality involves processing real-time fluoroscopic images and tracking instruments. The document describes "changes to the software" and new accessories, implying engineering and software development, but not a machine learning training phase with a specific dataset.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable/Not specified. As the device is not presented as an AI/ML system trained on a dataset requiring labeled ground truth in the traditional sense, this information is not relevant or provided in the context of this 510(k) summary. The "ground truth" for its development would be based on engineering principles, physics of imaging, and surgical requirements for accuracy and usability.
§ 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).