(30 days)
The Smith & Nephew PiGalileo Total Knee Replacement (TKR) system is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. ligament tension, limb alignment, etc.).
Examples of surgical procedures include but are not limited to:
- Total knee replacement supporting bone referencing technique
- Total knee replacement supporting ligament balancing technique
- Minimally invasive total knee replacement
The PiGalileo Navigation System is a software-controlled electromechanical stereotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties.
The PiGalileo TKR CAS V4.1 and Base V2.3 software applications are surgical techniques for computer assisted navigation that leverages PiGalleo Total Khee Replacement (TKR) instruments as well as a number of non-navigated knee instruments with the intent to optimally position knee prostheses during total joint arthroplasty.
The provided text describes a medical device, the Smith & Nephew PiGalileo Total Knee Replacement (TKR) Software Applications CAS V4.1 and Base V2.3, which is a computer-aided navigation system for total knee replacement surgery. However, the document does not contain information regarding detailed acceptance criteria, specific device performance measurements, study design details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or comparative effectiveness studies (MRMC) or standalone algorithm performance studies.
Instead, the document is primarily a 510(k) summary and FDA clearance letter, focusing on device description, classification, indications for use, and a statement of substantial equivalence to previously cleared devices.
Therefore, I cannot provide the requested table and study details as that information is not present in the given text.
§ 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).