(111 days)
The NaviPro™ Knee Software Module is an extension of the NaviPro™ Navigation System whose purpose is to measure the spatial orientation of the resection guides and limb alignment during total knee replacement surgery, and for assessing soft tissue balance and changes in the limb mechanical axis as a result of the knee replacement. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
The NaviPro™ Knee Software Module is an extension of the previously cleared The Navil Navigation System. It uses an optical localizing camera and infra-red Navil 10 - Navigation 173.60m. 'It ucces an valial position of bones and medical instruments during knee replacements obtained from the system allow for intra-operative assessments of implant position, orientation, and soft-tissue balance.
This 510(k) submission for the NaviPro™ Knee Software Module does not include a study describing acceptance criteria and device performance as typically expected for imaging or diagnostic AI/ML devices. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a surgical navigation system.
Therefore, many of the requested sections regarding acceptance criteria, study design, and ground truth cannot be directly extracted from the provided text.
However, I can provide information based on what is available:
1. A table of acceptance criteria and the reported device performance
The provided document does not contain an explicit table of acceptance criteria or reported device performance metrics in the way one would typically see for an AI/ML diagnostic device (e.g., sensitivity, specificity, AUC). The submission is for a surgical navigation software module, and its "performance" is more about its ability to accurately measure spatial orientation and alignment during knee replacement surgery, rather than a diagnostic output.
The summary of technological characteristics implies performance in terms of:
- Generating the position of tibial and femur resection guides.
- Measuring changes in the mechanical axis of the limb.
- Utilizing infra-red trackers for patient and instrument localization.
- Determining spatial information using trackers and palpated landmarks.
However, no quantitative acceptance criteria or specific performance data (e.g., accuracy in degrees or millimeters) are reported in this document.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not describe a "test set" in the context of validating an algorithm's diagnostic or predictive performance. As a surgical navigation system, its validation would likely involve precision and accuracy testing on models or cadavers, and potentially clinical use observational studies, but details of such studies (including sample sizes or data provenance) are not present here.
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)
Not applicable, as there's no mention of a "test set" requiring expert ground truth in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there's no mention of a "test set" requiring adjudication in the provided text.
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
Not applicable. The NaviPro™ Knee Software Module is a navigation tool for surgeons, not an AI-assisted diagnostic tool that would typically be evaluated with an MRMC study comparing human reader performance with and without AI. It assists the surgeon directly in guiding resections and assessing alignment.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently "human-in-the-loop" as it is a navigation system used by a surgeon during an operation. Its purpose is to provide real-time spatial information to the surgeon, rather than operate autonomously.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document focuses on the capabilities of the system to provide spatial measurements and guidance, rather than a diagnostic output that would have a "ground truth" established by pathology or expert consensus. The "ground truth" for a navigation system would relate to the physical accuracy of its measurements and guidance relative to a known reference standard (e.g., a highly accurate measuring device), but these details are not provided.
8. The sample size for the training set
The document does not describe a "training set" as it would for an AI/ML algorithm. The device is based on optical tracking and geometric calculations, not on a machine learning model trained on a dataset.
9. How the ground truth for the training set was established
Not applicable, as there's no "training set" in the AI/ML sense described.
Summary of the Device and Submission Context:
The NaviPro™ Knee Software Module is an extension of an existing surgical navigation system. Its function is to provide real-time spatial orientation measurements of resection guides and limb alignment during total knee replacement surgery. It also assists in assessing soft tissue balance and changes in the mechanical axis. The submission focuses on demonstrating substantial equivalence to predicate navigation devices, rather than presenting a performance study with acceptance criteria and ground truth typical for AI/ML diagnostic tools. The technology described relies on optical tracking of infra-red markers and palpated landmarks to determine spatial relationships.
§ 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).