QUADSENSE
Eventum Orthopaedics LtdQUADSENSE is a surgical tool used during total knee replacement surgery to help surgeons measure and compare the forces in the patellofemoral joint before and after patella resurfacing. The device includes a sensor attached to the patella and displays real-time force data to support surgical decision-making, improving joint alignment and implant positioning.
Intended Use
The Quadsense is indicated for use in primary Total Knee Arthroplasty (TKA), where the patella is resurfaced. For use as a comparative tool to measure patellofemoral joint force. Quadsense sensor is sterile, for single patient use. The device does not make a diagnosis and is not intended to replace a surgeon's clinical judgement.
Technology
QUADSENSE system comprises a sensor attached to the patella that measures loads at multiple points (medial, lateral, superior, inferior) during range of motion trials, with data displayed in real time on a touchscreen panel PC controlled by the surgeon via a control puck. The sensor is sterile, for single patient use, and attaches to the patella allowing assessment of patellofemoral joint forces before and after implant trials. Data transfer is via wired communication. Compatible shims adjust sensor geometry to simulate surgical changes.
Performance
The device underwent biocompatibility testing, electrical safety and electromagnetic compatibility testing (IEC 60601-1 and IEC 60601-1-2), software verification and validation according to FDA guidelines, cybersecurity risk management, and performance testing including load measurement accuracy, sterilization, packaging, shelf life, and usability. No animal or clinical performance testing was conducted as it was not deemed necessary for substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/8/2024
4 months - 2
FDA Approval
10/4/2024
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