(538 days)
The eLIBRA® Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee replacement. The unit displays a number from 0-19 for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). The force sensor is sterile, for single patient use.
The device consists of two units, the force sensing unit and an electronic display. The eLIBRA® Uni Soft-Tissue Force Sensor for a Partial Knee Replacement is a single use battery powered device designed to transmit an electronic signal to the eLIBRA™ Display Unit. The eLIBRA Display Unit is a reusable battery powered device designed to receive an electronic signal from the eLIBRA® Uni Force Sensing Unit. The unit displays a number from 0-19 for both the for flexion and extension positions of the knee joint to aid the surgeon in developing a balanced implantation during a primary unicondylar knee arthroplasty (UKA). Each number is equivalent to 0.5 pounds of force.
The provided 510(k) summary for the eLibra® Uni Soft Tissue Force Sensor (K093046) describes the device, its intended use, and claims substantial equivalence to a predicate device (K070108 eLibra Dynamic Knee Balancer). However, it does not contain the detailed performance study information typically required to fully answer all aspects of your request regarding acceptance criteria and a study demonstrating performance against those criteria.
The summary states: "Performance: Both bench and test laboratory testing was performed. Bench testing included mechanical testing, radio frequency, and sterility testing, including EO residues. The results were satisfactory and revealed no concerns over safety and effectiveness as compared to our predicate device. The tests demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device."
This statement indicates that performance testing was conducted, but it does not provide specific acceptance criteria, reported performance metrics, sample sizes, ground truth establishment, or details about the study design (e.g., MRMC, standalone). The focus of the summary is on demonstrating substantial equivalence rather than presenting detailed performance validation against specific, quantified acceptance criteria.
Therefore, for many of your questions, the information is not available in the provided text.
Here's a breakdown of what can and cannot be answered based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Specified | "Satisfactory" and "revealed no concerns over safety and effectiveness as compared to our predicate device." "Demonstrated that the device is as safe, as effective, and performs in a substantially equivalent manner to the predicate device." |
- Note: The document states that "Each number [displayed on the unit] is equivalent to 0.5 pounds of force." This is a functional specification, but not an acceptance criterion against which performance was directly measured and reported in terms of accuracy or precision.
2. Sample size used for the test set and the data provenance
- Not specified. The document mentions "bench and test laboratory testing" but does not give sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe any study involving human experts establishing ground truth for a test set. The validation seems to be primarily through engineering and comparative testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified. This type of adjudication method is typically used in clinical studies with human readers interpreting data, which is not described here.
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
- No. An MRMC study was not described, nor is this device an "AI" device in the conventional sense (it's a force sensor and display). The device directly aids the surgeon with a display of force, not by processing complex imaging or clinical data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable/Not explicitly detailed as such. The device itself is designed to provide real-time information to a surgeon. The "performance" described is the device's ability to measure and display force. Bench testing would inherently be "standalone" in that it tests the device's intrinsic functions, but the details are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated. For mechanical and RF testing, ground truth would likely be established using calibrated reference instruments (e.g., highly accurate force gauges, RF measurement equipment). For "sterility testing," the ground truth would be the absence of viable microorganisms as per validated sterilization methods.
8. The sample size for the training set
- Not applicable/Not specified. This device does not appear to be an AI/machine learning device that requires a "training set." It's a sensor and display unit.
9. How the ground truth for the training set was established
- Not applicable. As above, a training set is not relevant for this type of device.
In summary, the 510(k) process for this device focused on demonstrating substantial equivalence through bench and laboratory testing without providing detailed quantitative performance metrics or descriptions of clinical studies in the summary document. The information provided is insufficient to answer most of your detailed questions about acceptance criteria and study particulars.
§ 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).