Search Results

TrackX v.2.0 is intended for use in any application where a fluoroscope is incorporated to aid in the diagnosis and treatment of disease.

TrackX is a software application which captures diagnostic images from 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. TrackX works by translating and rotating an X-ray image which contains the surgical instrument on the screen based on the surgeon's movement of the instrument. This real-time feedback allows the physician to reposition the instrument with greater accuracy between X-ray images. This aids the physician in repositioning their surgical instruments by providing visual feedback on where they have moved their instruments between X-ray images.

The provided FDA 510(k) summary for TrackX v.2.0 (K200360) describes the device's acceptance criteria and the study that proves the device meets them.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The provided document does not specify the sample size used for the bench testing of "Instrument Tracking with Optical" or the software verification testing. It also does not explicitly state the provenance of the data (e.g., country of origin, retrospective or prospective) for these tests. The testing described is "bench testing," which typically refers to lab-based, simulated scenarios rather than patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not mention the use of experts to establish a ground truth for the test set. The "Instrument Tracking with Optical" testing appears to rely on a predefined, expected 10mm increment for projected markers, suggesting a technical ground truth rather than expert interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

No adjudication method is mentioned in the provided summary. The testing described is bench testing against predefined technical specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed or needed as indicated by the statement: "Clinical Study: Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This device is a software application that assists with fluoroscopic procedures by tracking instruments and providing visual cues, not an AI-driven diagnostic reader.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Yes, the performance data presented (Bench Testing, Software Verification and Validation) represents standalone testing of the algorithm/software's functionality and accuracy against predefined specifications, without human-in-the-loop performance evaluation in a clinical setting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the "Instrument Tracking with Optical" bench testing, the ground truth was based on expected technical measurements (e.g., the "expected 10mm increment" between projected markers). For the "Software Verification," the ground truth was the intended functionality and changes for the new features (Projection and Home Base Selector).

8. The sample size for the training set

The document does not provide any information about a training set. This is because TrackX v.2.0 is described as a software application that captures images and interfaces with a tracking system to translate and rotate images and track instrument location. It does not appear to be an AI/machine learning device that requires a training set in the conventional sense for image classification or prediction. The changes are "new features, Projection and Home Base Selector," which are functionally implemented, not learned.

9. How the ground truth for the training set was established

As no training set is mentioned or implied for this type of device and its new features, information on how its ground truth was established is not applicable.

Ask a specific question about this device

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:

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.

Ask a specific question about this device