(76 days)
The Navitrack® System – OS Knee Universal is indicated for use as a stereotaxic instrument to assist in the positioning of Total Knee Replacement components intraoperatively.
It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, and in precisely positioning the alignment instruments relative to these axes by displaying their locations.
The Navitrack System - OS Knee Universal device consists of software, a computer workstation, an optical tracking system, surgical instruments, and tracking accessories, designed to assist the surgeon in the placement of total knee replacement components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to each of the femur and tibia, such to allow the ability to track and display to the user their respective positions intra-operatively. The femur and tibia are displayed to the user in the form of their main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the components.
The provided text is a 510(k) summary for the Navitrack® System - OS Knee Universal, a computer-assisted surgical navigation system for Total Knee Replacement. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria and performance metrics typically found in efficacy trials for novel devices.
Therefore, much of the requested information regarding detailed acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods is not explicitly available in this document. The document describes non-clinical tests and validation on cadavers, but does not provide specific quantitative results against pre-defined acceptance criteria.
Below is an attempt to address the request based on the available information, noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No new safety and efficacy issues are raised by the modifications to the predicate device. | Non-clinical tests (bench tests, simulated use on cadavers) confirmed that the proposed bone references function as required, provide adequate fixation, and do not interfere with other instrumentation. For other changes, similar non-clinical verification and validation testing was performed. The device was deemed substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "simulated use on cadavers," implying a cadaveric study, but numbers are not provided.
- Data Provenance: The tests were conducted internally by the manufacturer ("Non-clinical tests were performed to assess...") as part of a 510(k) submission. The exact country of origin for the cadavers or test facility is not specified but the applicant is based in Montreal, Quebec, Canada. The testing was prospective for the device modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not explicitly mentioned. Given the nature of cadaveric testing for a surgical navigation system, ground truth would likely be established through direct measurement or observation during the simulated surgical procedures, potentially involving qualified surgical personnel, but the specific method is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document describes non-clinical testing for substantial equivalence, not a comparative study with human readers or clinical outcomes.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance: The performance data described is a form of standalone performance in a simulated environment (cadaveric testing) to assess the device's functionality. The focus is on the device's ability to track and display anatomical information and instrument positions accurately, rather than an evaluation of an algorithm's diagnostic output. Specific metrics of standalone accuracy (e.g., angular deviation, translational error) are not quantified in this summary.
7. Type of Ground Truth Used
- Ground Truth Type: Based on "simulated use on cadavers" and "Non-clinical tests," the ground truth was likely established through direct physical measurement and observation within the cadaveric environment of anatomical landmarks and instrument positions, to verify the system's accuracy and functionality. It would be a technical/engineering ground truth related to mechanical and tracking accuracy.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable in the traditional sense of machine learning training data. This device is a stereotaxic instrument for surgical guidance, not a diagnostic AI system that learns from a large dataset. The "training" in this context refers to the development and refinement of the software and hardware, which occurs iteratively rather than through a distinct "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set Establishment: Not applicable as there isn't a "training set" in the machine learning sense. The underlying physics and algorithms for tracking and navigation are based on established principles, and their accuracy would be continuously validated during the device's development cycle against known physical properties and measurements.
§ 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).