(64 days)
Ci TKR/UKR is intended to be an intraoperative image guided localization system to enable minimally invasive surgery. It links a freehand probe, tracked by a passive marker sensor system to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. The system is indicated for any medical condition in which the use of stereo tactic surgery may be appropriate and where a reference to a rigid anatomical structure, such as the skull, a long bone, or vertebra, can be identified relative to a CT, X-ray, MR based model of the anatomy. The system aids the surgeon to accurately navigate a knee prosthesis to the intraoperatively planned position. Ligament balancing and measurements of bone alignment are provided by Ci TKR/UKR.
Example orthopedic surgical procedures include but are not limited to:
Knee Procedures: Total Knee Replacement Unicondylar Knee Replacement Ligament Balancing Range of Motion Analysis Cruciate Ligament Surgery Patella Tracking
Ci TKR/UKR is intended to enable operational planning and navigation in orthopedic surgery. It links a surgical instrument, tracked by flexible passive markers to virtual computer image space on an individual 3D-model of the patient's bone, which is generated through acquiring multiple landmarks on the bone surface. Ci TKR/UKR uses the registered landmarks to navigate the femoral and tibial cutting guides and the implant to the planned optimally position.
Ci TKR/UKR allows 3-dimensional reconstruction of the mechanical axis and alignment of the implants. Ci TKR/UKR software registers the patient data needed for planning and navigating the surgery intraoperatively. No preoperative CT-scanning is necessary.
Ci TKR/UKR software has been designed to read in implant data from DePuy and offers to individually choose the prosthesis during each surgery.
The provided text describes the Ci TKR/UKR (Kolibri Knee) image-guided surgical system, but it does not contain information about the acceptance criteria or a specific study proving the device meets those criteria, nor any performance metrics.
The document is a 510(k) summary and FDA clearance letter, which focuses on establishing substantial equivalence to predicate devices rather than detailing performance studies with specific statistical outcomes or acceptance criteria.
Therefore, I cannot populate the requested table or answer most of the questions as the information is not present in the provided text.
Here's what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance:
- No specific acceptance criteria or reported device performance metrics are provided in this document. The document states "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510 (k) application was found to be substantially equivalent with predicate devices..." indicating that validation was performed, but the details of that validation (criteria, results) are not included here.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not specified in the document.
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 specified in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified in the document.
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. This device is an image-guided surgical system, not an AI or diagnostic imaging device that involves human "readers" or "interpreters" in the context of MRMC studies. Its purpose is to assist surgeons in navigation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This device is inherently "human-in-the-loop" as it's an image-guided surgical system designed to assist a surgeon. The document does not describe standalone algorithm performance for tasks like diagnosis or prediction. Its function is to provide real-time navigation assistance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the document. Given the nature of a navigation system, ground truth would likely relate to the accuracy of instrument positioning relative to planned positions or actual anatomical landmarks, but the method for establishing this is not detailed.
8. The sample size for the training set:
- Not applicable/Not specified. This document does not describe a machine learning model with a distinct "training set." The system uses 3D models generated from patient bone landmarks intraoperatively.
9. How the ground truth for the training set was established:
- Not applicable/Not specified.
Summary of what is known from the provided text:
- Manufacturer: BrainLAB AG
- Device Name: Ci TKR/UKR (Kolibri Knee)
- Intended Use: Intraoperative image-guided localization system to enable minimally invasive surgery, aiding surgeons to accurately navigate knee prostheses, provide ligament balancing, and measure bone alignment.
- Mechanism: Links a freehand probe (tracked by passive markers) to a virtual computer image space on an individual 3D-model of the patient's bone, generated through acquiring multiple landmarks on the bone surface.
- Key Feature: No preoperative CT-scanning is necessary.
- Regulatory Status: Cleared via 510(k) process based on substantial equivalence to predicate devices (BrainLAB Vector Vision® CT-free knee and BrainLAB Kolibri™ Image Guided Surgery System).
- Validation: The text states, "The validation proves the safety and effectiveness of the information provided by BrainLAB in this 510(k) application was found to be substantially equivalent with predicate devices..."
To answer the detailed questions, a more comprehensive technical report or validation study document would be required, rather than just the 510(k) summary and FDA clearance letter.
§ 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).