(258 days)
NuVasive Navigation.S Instruments are intended to be used during the preparation and placement of NuVasive screws (Reline, Reline C, and VuePoint fixation systems) and disc preparation during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures.
The navigated disc preparation instruments are intended to facilitate a discectomy or boney resection during spinal surgery. The navigated trials are intended to be used to facilitate implant size selection of NuVasive intervertebral body fusion devices during spinal surgery.
NuVasive Navigation.S 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy.
NuVasive Navigation.S Instruments are manual, non-sterile re-usable, or sterile single use surgical instruments intended for use with the 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 and preparation for placement of interbody implants during spinal surgery.
The provided text is a 510(k) summary for NuVasive Navigation.S Instruments, which are orthopedic stereotaxic instruments. This document describes the device, its intended use, and its substantial equivalence to predicate devices. It does not contain the detailed information required to describe acceptance criteria and a study proving a software-based device meets those criteria, specifically concerning AI/ML performance.
The "Performance Data" section mentions "Dimensional analysis," "testing per ASTM F2554 Standard Practice for Measurement of Positional Accuracy of Computer Assisted Surgical Systems," and "compatibility testing for disc preparation instruments with Medtronic StealthStation." These are engineering and functional tests for a physical surgical instrument's accuracy and compatibility within a navigation system, not a study evaluating the performance of an AI/ML algorithm.
Therefore, within the provided text, it is not possible to answer the detailed questions about acceptance criteria and a study proving an AI/ML device meets them because the device in question is a physical surgical instrument, not an AI/ML diagnostic or prognostic system.
I cannot create the requested table or answer the specific questions about AI/ML study design, ground truth, expert adjudication, or MRMC studies based on the provided document.
If you have a different document describing an AI/ML medical device submission, please provide that.
§ 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).