(351 days)
PERSEUS is a computer-controlled system, intended to assist in distal femoral resection and tibial resection during Total Knee Arthroplasty, determining reference alignment axes in relation to anatomical and instrumentation structures during stereotaxic orthopaedic surgical procedures.
PERSEUS is a computer assisted system, that helps surgeon in the positioning of implant components, during total knee implant surgical procedure, according to the conventional reference axes in relation to anatomical landmarks. Perseus System is configured to detect, measure, and display angular and positional measurement changes in a triaxial format. The device assists the surgeon in: Establishing the mechanical axis of the femur, determining the varus/valgus angle and the flexion/extension angle of the cutting block relative to the femur. Establishing the mechanical axis of the tibia, determining the varus/valgus angle and the posterior slope angle of the cutting block relative to the tibia. Perseus system utilizes triaxial accelerometer and triaxial gyroscope to determine, through limb movement, reference axes of femur and tibia and relative orientation of distal femoral and tibial cutting guide with respect to frontal and sagittal planes of the limb.
Here's a detailed breakdown of the acceptance criteria and the studies proving the device's performance, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Measure | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| HKA (Hip-Knee-Ankle) angle deviation | within 3° (for final leg alignment) | Average post-operative HKA angle deviation: 0.3 ± 1.5° |
| Average post-operative HKA alignment deviation: 0.7° (range 0-2°) | ||
| Femoral distal resection deviation | within 2° (for distal femoral resection, frontal and lateral planes) | Femoral distal resection deviation: |
§ 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).