(84 days)
TrackX is intended for use in any application where a fluoroscope is incorporated to aid in diagnosis and treatment of disease.
TrackX is a software application which captures diagnostic images using a fluoroscope via a video cable. In addition. TrackX interfaces with an off-the-shelf tracking system in order to track the position of surgical instruments relative to the fluoroscope. The user controls and views information via a primary monitor. The viewing monitor is not part of the subject device.
TrackX will track the location of the tip of a surgical instrument. Instrument tracking is accomplished using either an electromagnetic or optical tracking system with one tracker mounted on the surgical instrument and another tracker mounted on the fluoroscope. When used with an electromagnetic tracking system. Civco's eTRAX Needle Tip Tracking system is used. When used with an optical tracking system. TrackX snaps are used.
The tracking information is then fed into the TrackX software which manipulates the location of an X-ray image based on movement of the tracked surgical instrument tracking aids the physician in repositioning their surgical instruments by providing visual feedback on where they have moved their instruments between X-ray images. Additionally, TrackX can register the current image being taken (which contains the surgical instrument) with a prior Baseline image of the same anatomy and then use the Baseline image as a Background which the current image is translated over as part of instrument tracking.
TrackX can be used with either electromagnetic tracking or optical tracking. The C-arm tracking feature of the predicate device creates a viewfinder for the fluoroscope which allows the user to track the C-arm movement as they localize and relocalize the fluoroscope during an intervention. While TrackX does not provide this feature, it is still necessary to mount components to the Carm so that its position can be tracked. The C-arm's tracked position is used to detect the Carm's orientation and to track the position of instruments relative to the C-arm.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Instrument Tracking with Optical (Bench Test) | TrackX able to guide the user back to the location where the instrument was in the previous X-ray image so that the instrument is close enough to original location to perform a medical intervention. | TrackX met specifications. |
| Instrument Tracking with EM (Bench Test) | TrackX able to guide the user back to the location where the instrument was in the previous X-ray image so that the instrument is close enough to original location to perform a medical intervention. | TrackX met specifications. |
| Glyph Tracking (Regression Test) | Glyph detection meets requirements for accuracy, precision, and speed as specified in the Software Requirement Specification. | The results demonstrated that the glyph detection meets the requirements for accuracy, precision, and speed required by TrackX, as specified in the Software Requirement Specification. |
| Image Registration Performance (Regression) | Image Registration performs within time and resolution constraints specified in the Software Requirement Specification. | For all computer platforms tested, TrackX was able to display and register images well within the required speeds. |
| Image Registration (Regression Test) | Image registration algorithm performs the same as in the predicate device, correctly registering images that should be registered and rejecting images that should not be registered. | The results of the study demonstrated that the image registration algorithm performs the same in the subject as it does in the predicate device. Both algorithms correctly registered images that should be registered and rejected images that should not be registered. Studies on live pigs and parallax studies provided with the predicate LessRay submission demonstrate that TrackX is able to register a static baseline with an X-ray taken under conditions where the anatomy is moving or where the fluoroscope or patient have been moved. The studies demonstrate that TrackX is capable of working during interventions on living animals, with patient shift, and with organ/structure motion. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the numerical sample sizes for each specific test set (e.g., number of images, number of tracking attempts). However, it implies testing was conducted on various computer platforms for "Image Registration Performance" and through "studies on live pigs and parallax studies" for "Image Registration Regression" from the predicate device submission. The data provenance includes "studies on live pigs" which suggests animal data, but further details on the country of origin or whether it was retrospective or prospective are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The tests seem to be focused on technical performance against internal specifications rather than expert-derived ground truth.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted or mentioned for the TrackX device in this submission. The document states: "Clinical studies are not necessary to establish the substantial equivalence of this device."
6. Standalone Performance Study:
Yes, a standalone performance study was done. The bench testing and regression testing described (Instrument Tracking with Optical, Instrument Tracking with EM, Glyph Tracking, Image Registration Performance, Image Registration) are evaluations of the algorithm's performance independent of human-in-the-loop interaction, focusing on whether the software meets its specified technical requirements and performs comparably to the predicate's instrument tracking component.
7. Type of Ground Truth Used:
The ground truth used appears to be primarily based on technical specifications and measurements against known values for accuracy, precision, speed, and correct registration/rejection of images as defined in the Software Requirement Specification. For the "Image Registration Regression" test, the ground truth indirectly relies on the performance demonstrated in "studies on live pigs and parallax studies" from the predicate device that established the algorithm's capability to register static baselines with X-rays under dynamic conditions.
8. Sample Size for the Training Set:
The document does not mention a specific training set size or methodology, as the device is presented as utilizing the "same codebase as the instrument tracking component of the NuVasive LessRay with Enhanced Tracking system," implying its development and any associated training were conducted as part of the predicate device.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the document, as it refers to the codebase of the predicate device. For the predicate device's development, it would have likely involved similar technical specifications, potentially human expert input during development, and potentially data from preclinical studies to establish the ground truth for its instrument tracking functionality. However, the details for TrackX's training set (if any distinct from the predicate) are absent.
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.