(88 days)
The Invictus Robotic Navigation Instruments are indicated for use during the placement of Invictus Spinal Fixation System modular screws in either open or minimally invasive procedures. The Invictus Robotic Navigation Instruments are specifically designed for use with Globus Medical's Excelsius GPS® Robotic Navigation Platform, which is intended for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of an instrument holder or quide tube to be used by surgeons for navigating and/or quiding compatible surgical instruments in open or percutaneous procedures, provided that the required fiducial markers and rigid patient anatomy can be identified on CT scans or fluoroscopy.
The Invictus Robotic Navigation Instruments are surgical instruments that is designed to be compatible with Globus Medical's Excelsius GPS® Robotic Navigation Platform. The subject device is intended to facilitate the placement of screws during spinal surgery. The subject device are reusable instruments and offered non-sterile to be cleaned and steam sterilized by the end user.
The provided text is a 510(k) summary for the "Invictus Robotic Navigation Instruments." This document is a regulatory submission to the FDA, demonstrating substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for an AI/software as a medical device (SaMD).
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving device performance in the context of an AI/SaMD.
Specifically:
- There is no table of acceptance criteria and reported device performance.
- There is no mention of a test set, training set, sample sizes, data provenance, or ground truth.
- The document explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."
- It also states that performance data relied on "dimensional analysis and geometric comparison to the predicate devices."
The device described is a set of "surgical instruments" intended for use with a robotic navigation platform, not an AI or software algorithm that analyzes data or images. The "performance data" refers to engineering analyses to show substantial equivalence of physical instruments, not the performance of an AI model.
§ 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).