(46 days)
The NaviPro"" Shoulder Software Module is a system for computer-aided navigation of surgical instruments whose purpose is to intra-operatively report the orientation of the glenoid and humeral components during shoulder replacement surgery. General spatial measurements may be made and recorded as deemed necessary by the surgeon user.
The NaviPro" Shoulder Software Module is an extension of the previously cleared NaviPro Navigation System. It uses an optical localizing camera and infra-red reflective markers ("trackers") to track the spatial position of bones and medical instruments during shoulder replacement surgery. Measurements obtained from the system allow for intra-operative assessments of implant position and orientation.
The provided text is a 510(k) summary for the NaviPro™ Shoulder Software Module, focusing on its substantial equivalence to previously cleared devices. It describes the device's function, intended use, and technological characteristics. However, it does not contain any information regarding acceptance criteria, reported device performance, sample sizes, ground truth establishment, or study methodologies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided input.
The document essentially states that the device is substantially equivalent to a predicate device and provides its intended use, but it does not delve into the specific performance validation study details you've asked for.
To answer your questions, I would need additional information specifically outlining the performance study conducted for the NaviPro™ Shoulder Software Module.
§ 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).