(111 days)
NuVasive® Navigation Instruments are intended to be used during the preparation and placement of NuVasive screws (Armada, Reline, Precept, MAS PLIF, and VuePoint fixation systems) during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. NuVasive® Navigation Instruments are designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
NuVasive Navigation Instruments are manual, non-sterile, re-usable, surgical instruments intended for use with Medtronic StealthStation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of NuVasive screws during spinal surgery.
The document provided does not contain a study that proves the device meets specific acceptance criteria in terms of reported device performance based on quantitative metrics. The FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.
The "Performance Data" section (G) on page 4 mentions "Accuracy testing," "Compatibility testing," and "Performance testing" were performed, and concludes that "results demonstrate that the subject NuVasive Navigation Instruments are substantially equivalent to the predicate." However, it does not provide details about the specific acceptance criteria for these tests, the reported performance metrics, the sample sizes, data provenance, ground truth establishment, or any information related to expert involvement or comparative effectiveness.
Therefore, I cannot provide the requested information from the given document as it is not present.
§ 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).