(90 days)
The Naviswiss Knee Navigation System is a computer-controlled system intended to assist the surgeon in determining reference alignment axes to aid in the positioning of orthopedic implant system components where a reference to a rigid anatomical structure can be identified. The system aids the surgeon in performing intra-operative measurements of femoral and tibial alignment axes to assist in executing the distal femoral and proximal tibial resections. The equipment is intended for use by trained surgeons in operating theaters.
The Naviswiss Knee is a surgical navigation system which assists the orthopaedic surgeon during the implantation of an artificial knee joint. It consists of a navigation unit which is first used to register the patient's anatomy. Subsequently the navigation system supports the surgeon in guiding the surgical instruments with the implant according to the pre-operative planning. The navigation unit includes an infrared stereo camera which measures the position and orientation of small NAVItags.
The Naviswiss Knee is a surgical navigation system that assists orthopedic surgeons in knee joint implantation.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Benchtop Accuracy | All requirements met | All requirements met |
| Clinical Accuracy (Simulated Use) | Satisfies user needs, intended use, and clinical accuracy requirements | Measurements obtained in simulated use compared favorably with known values |
| Cadaver Simulated Use | Satisfies clinical use requirements and performs as intended on human specimens in an OR environment by trained surgeons | Met requirements |
2. Sample Size and Data Provenance:
- Test Set: No specific numerical sample size (e.g., number of cases or patients) is provided for the simulated use or cadaver testing.
- Simulated Use: Performed on a metallic bone simulator.
- Cadaver Simulated Use: Performed in multiple cadaver wet labs.
- Data Provenance: The study appears to be entirely benchtop and simulated-use based, not involving human patients in a clinical setting. Therefore, there is no country of origin for patient data, and it is not retrospective or prospective in a typical clinical trial sense.
3. Number of Experts and Qualifications:
- For the Anatomical Phantom Simulated Use, "orthopedic surgeons" were involved. No specific number or years of experience are detailed.
- For Cadaver Simulated Use, "trained surgeons" were involved. No specific number or qualifications are detailed.
4. Adjudication Method:
The document does not specify an adjudication method like 2+1, 3+1, or none. The assessment seems to be based on direct comparison of measurements to known values in the simulated environment and verification of meeting clinical use requirements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was mentioned. The study focused on the performance of the device itself rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance:
Yes, a standalone performance assessment was conducted through "Benchtop Accuracy" testing, where the device's accuracy was verified using calibrated test fixtures.
7. Type of Ground Truth Used:
- For Benchtop Accuracy and Anatomical Phantom Simulated Use, the ground truth was "known values" or "calibrated test fixtures." This implies established, precise measurements for comparison.
- For Cadaver Simulated Use, the ground truth was likely expert assessment by the trained surgeons on whether the system "satisfies clinical use requirements and performed as intended on human specimens."
8. Sample Size for Training Set:
The document does not provide any information regarding a training set sample size. This is typical for a navigation system where the core technology is based on precise physical measurements and algorithms rather than machine learning models that require distinct training data.
9. How Ground Truth for Training Set Was Established:
Not applicable, as no information on a training set or machine learning model is provided.
§ 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).