(28 days)
The 360CAS is indicated for patients undergoing orthopaedic surgery and where reference to a rigid anatomical structure can be identified.
The 360CAS Knee is indicated for the following surgical procedures:
- · Any form of Total Knee Arthroplasty (TKA)
- · For conditions of the knee joint in which the use of computer assisted surgery may be appropriate
The 360CAS Hip is indicated for the following surgical procedures:
· Any form of Total Hip Arthroplasty (THA) e.g., open or minimally invasive, where a posterior or anterior approach is used
· For conditions of the hip joint in which the use of computer assisted surgery may be appropriate
The 360 Computer Assisted Surgery (360CAS) is a stereotaxic surgical navigation system for orthopaedic surgical procedures. The 360CAS is intended to be used as a planning and intraoperative quidance system with any manufacturers implant in open or percutaneous orthopaedic surgical procedures. The 360CAS uses optical tracking technology that allows surgeons to map subject's morphology, navigate surgical instruments and implants and assess state of the joint throughout the surgery. The system consists of 360CAS navigation software, which consists of two modules: 360CAS Knee and 360CAS Hip, surgical instruments, spatial tracking components and a navigation cart. 360CAS Knee is a 360CAS navigation software for knee replacement surgery. 360CAS Hip is a 360CAS navigation software for hip replacement surgery. The navigation software interfaces with the optical trackers which are attached to navigation instruments (e.g., pointer, bone fixator(s)).
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| System Accuracy (Translational Error) |
§ 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).