(197 days)
The Navitrack™ System – Total Hip Replacement is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system that integrates a threedimensional tracking sub-system and image-processing software. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images.
The Navitrack™ System - Total Hip Replacement 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 Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as onto fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intra-operatively. The bones of interest are displayed to the user as three-dimensional (3D) surface models, while the instruments are schematically represented. Models of the implant are also represented in order to visualize their placement using the instruments. The 3D models of the pelvis are reconstructed pre-operatively from given CT-images using image processing tools provided with the software. The software also provides planning features by allowing the user to determine pre-operatively an ideal location for the implants as based on the models.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Navitrack™ System - Total Hip Replacement:
1. Table of Acceptance Criteria and Reported Device Performance:
The document mentions that "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 to perform as intended." However, it does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. It broadly states that the system's "accuracy and performance...was adequate."
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy | Not explicitly stated in the document | "adequate to perform as intended" |
| Performance | Not explicitly stated in the document | "adequate to perform as intended" |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for the test set. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be non-clinical, implying it was likely conducted in a lab environment rather than with patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
The document does not mention the use of experts to establish ground truth for a test set. This is consistent with the nature of the "non-clinical tests" described, which likely involved technical verification rather than medical interpretation.
4. Adjudication Method for the Test Set:
Since there's no mention of experts or a test set requiring interpretation, there's no information on any adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on the device's standalone performance and its equivalence to predicate devices, not on how human readers perform with or without AI assistance.
6. Standalone (Algorithm Only) Performance:
Yes, a standalone performance assessment was done. The document 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 to perform as intended." This indicates that the device, as an "algorithm only without human-in-the loop performance" component, was tested.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used. Given the nature of the device (a stereotaxic instrument for hip replacement component positioning) and the "non-clinical tests," the ground truth was likely based on engineering specifications, physical measurements, and known geometric truths obtained in a controlled laboratory setting (e.g., using phantoms or precise physical models). It was not based on expert consensus, pathology, or outcomes data in a clinical sense.
8. Sample Size for the Training Set:
The document does not mention a training set sample size. The "non-clinical tests" seem to refer to verification and validation of the completed system, not a machine learning model that would require a separate training set. The device uses "models of the pelvis... reconstructed pre-operatively from given CT-images using image processing tools provided with the software," implying rule-based or traditional image processing rather than data-driven machine learning that typically requires a training set.
9. How Ground Truth for the Training Set Was Established:
Since a training set is not explicitly mentioned as being used for a machine learning model, there's no information on how its ground truth would have been established. The device relies on "image processing tools" and 3D surface model reconstruction from CT images, suggesting a deterministic approach rather than one requiring labeled training data for an AI model.
§ 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).