(70 days)
The Navitrack™ System - Total Hip Replacement CT-Free Cup is indicated for use as a stereotaxic instrument to assist in the positioning of hip replacement components. It is a computer controlled image-guidance system equipped with a three-dimensional tracking sub-system. It is intended to assist in precisely positioning hip replacement components intra-operatively by displaying their positions relative to the joint's alignment axes as based on user-identified anatomical landmarks.
The Navitrack™ System - Total Hip Replacement CT-Free Cup device consists of a software-driven workstation, an optical tracking system, surgical instruments, and tracking accessories. It is designed to assist the surgeon in the placement of Total Hip Replacement (THR) components. Tracking devices are incorporated with given surgical instruments, as well as on to fixation bases that attach to the pelvis, such to allow the ability to track and display to the user their respective positions intra-operatively. The pelvis is displayed to the user in the form of its main alignment axes. The alignment axes are determined and recorded intra-operatively by identifying the key anatomical references that are used clinically to align and position the THR components. The instruments are schematically represented.
The provided text does not contain any information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the Navitrack™ System - Total Hip Replacement CT-Free Cup, focusing on demonstrating substantial equivalence to a predicate device.
Specifically, the "Performance Data" section states: "Non-clinical tests were performed to assess that no new safety and efficacy issues were raised in the device. They consisted in verifying that the accuracy and performance of the system was adequate as compared to the predicate." This indicates that some form of comparison was done, but no specific acceptance criteria, study design, or performance metrics are detailed.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study to prove they are met. The information is simply not present in the provided 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).